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Global Vision about the Biological Medicinal Products: Biosimilars (April, 2009).Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The prime difference between generics and biosimilars is that while generics contain the exact active ingredient as in the originator product, biosimilars are only "similar" and not "identical" to the originator biological medicine. This difference appears due to the nature of the biopharmaceutical medicines which are extremely complex to manufacture (it is not possible to make an exact copy of a biotech medicine in the same way as a traditional chemical molecule can be copied). In fact, it is widely accepted that for biopharmaceuticals, the "process is the product". Minor changes during the manufacturing process can h...
Source: Current Pharmaceutical Biotechnology - November 16, 2009 Category: Biotechnology Authors: Calvo B, Zuñiga L Tags: Curr Pharm Biotechnol Source Type: journals

HPV Viral Activity By mRNA-HPV Molecular Analysis To Screen The Transforming Infections In Precancer Cervical Lesions.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: the contemporary utilization of E6-E7 oncoproteins and related mRNA expression showed a more appropriate HPV evaluation in at risk women. The HPV-DNA tests does not distinguish between transient and potentially transforming infection, while the detection of E6-E7 mRNAs could early target the presence of an active HPV infection. PMID: 19912106 [PubMed - as supplied by publisher] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - November 16, 2009 Category: Biotechnology Authors: Tinelli A, Leo G, Pisanò M, Storelli F, Vergara D, Malvasi A Tags: Curr Pharm Biotechnol Source Type: journals

Effects of Arginine on Photostability and Thermal Stability of IgG1 Monoclonal Antibodies.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study demonstrates that arginine is a highly effective solvent additive which significantly reduces the light induced aggregation of four IgG1 type monoclonal antibodies (named as IMC-1A, IMC-1B, IMC-1C and IMC-1D) as measured by size exclusion chromatography. All experiments were performed in a phosphate buffer system containing either sodium chloride or arginine hydrochloride. The protein samples were exposed to light in a photo chamber according to ICH (International Conference on Harmonization) guidelines. Thermal unfolding transition temperature (T(m)) of IMC-1A as determined by differential scanning calorimetry ...
Source: Current Pharmaceutical Biotechnology - November 16, 2009 Category: Biotechnology Authors: Maity H, O'Dell C, Srivastava A, Goldstein J Tags: Curr Pharm Biotechnol Source Type: journals

The Hydroxyl-Functionalized Magnetic Particles for Purification of Glycan-Binding Proteins.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Glycan-protein interactions play important biological roles in biological processes. Although there are some methods such as glycan arrays that may elucidate recognition events between carbohydrates and protein as well as screen the important glycan-binding proteins, there is a lack of simple effectively separate method to purify them from complex samples. In proteomics studies, fractionation of samples can help to reduce their complexity and to enrich specific classes of proteins for subsequent downstream analyses. Herein, a rapid simple method for purification of glycan-binding proteins from proteomic samples was dev...
Source: Current Pharmaceutical Biotechnology - November 16, 2009 Category: Biotechnology Authors: Sun X, Yang G, Sun S, Quan R, Dai W, Li B, Chen C, Li Z Tags: Curr Pharm Biotechnol Source Type: journals

Bioactive Components and Pharmacological Action of Wikstroemia indica (L.) C. A. Mey and its Clinical Application.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Wikstroemia indica (L.) C. A. Mey. is a member of family Thymelaeaceae and mainly distributed in middle and southeast part of China. As a traditional Chinese herb, this plant has long been employed as antipyretics, detoxicants, expectorants, vermifuges as well as aborticides in clinic practice. However, its use has mainly been based on empirical findings during hundreds and thousands of years. Recent studies indicated that W. indica contains abundant active components including flavonoids, biflavonoids, coumarins, lignans, volatile oils, polysaccharides etc. This paper provides a comprehensive review of pharmacological...
Source: Current Pharmaceutical Biotechnology - November 16, 2009 Category: Biotechnology Authors: Li YM, Jiang JG, Yang L, Wang DY Tags: Curr Pharm Biotechnol Source Type: journals

Evaluation of ISCOMs for Immunization against Hepatitis B.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Immune stimulating complexes (ISCOMs) incorporating recombinant hepatitis B surface antigen (rHBsAg) were prepared for induction of humoral and cellular immunity by subcutaneous administration. Prepared ISCOMs were characterized for their size, shape, incorporation efficiency, zeta potential, antigen integrity, antigen conformation and immunogenicity by biophysical and immunological techniques including transmission electron microscopy (TEM), Dynamic light scattering (DLS), SDS-PAGE, fluorescence spectroscopy, in vitro potency test and in vivo humoral and cellular immune stimulatory efficacy in Balb/c mice. Prepared IS...
Source: Current Pharmaceutical Biotechnology - September 12, 2009 Category: Biotechnology Authors: Pandey RS, Dixit VK Tags: Curr Pharm Biotechnol Source Type: journals

Comparative Binding Analysis of Monoclonal Antibodies against Native and Mutant Type in ErbB2 Receptor: A Theoretical Modeling Approach.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In this study, we identified that the most detrimental single point mutation is from tryptophan to cysteine at the residue position of 452 on ErbB2 receptor by using I-Mutant 2.0, SIFT and PolyPhen programs. The modeled mutant showed less stability than native ErbB2 protein based on both total energy of the mutant and stabilizing residues in the mutant protein. This is due to deviation between the mutant and native ErbB2 having the RMSD of about 2.83A. Further, we found, pertuzumab showed a marginal higher binding affinity with ErbB2 receptor of native and mutant type with a binding free energy of -16.01 kcal/mole each as ...
Source: Current Pharmaceutical Biotechnology - September 12, 2009 Category: Biotechnology Authors: Rajasekaran R, Rao S Tags: Curr Pharm Biotechnol Source Type: journals

Efficient Production of Gossypol from Hairy Root Cultures of Cotton (Gossypium hirsutum L.).Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A protocol for induction and establishment of Agrobacterium rhizogenes mediated hairy root culture of Gossypium hirsutum was developed through infection with the A4 strain and co-cultivation on hormone-free semi-solid MS medium with B5 vitamins. It resulted in the emergence of hairy roots from the leaf explants, 21 days after infection. The transformation of hairy roots was established by PCR amplification of rol B and rol C genes of the Ri plasmid. All root lines expressed gossypol, although distinct inter-clonal quantitative variations were noticed. Five independent hairy root lines were studied for their growth kine...
Source: Current Pharmaceutical Biotechnology - September 12, 2009 Category: Biotechnology Authors: Verma PC, Trivedi I, Singh H, Shukla AK, Kumar M, Upadhyay SK, Pandey P, Hans AL, Singh PK Tags: Curr Pharm Biotechnol Source Type: journals

Clinical Applications of Creatine Supplementation on Paediatrics.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Creatine plays a central role in energy metabolism and is synthesized in the liver, kidney and pancreas. In healthy patients, it is transported via the blood stream to the muscles, heart and brain with high and fluctuating energy demands by the molecule creatine transporter. Creatine, although naturally synthesized in the human body, can be ingested in the form of supplements and is commonly used by athletes. The purpose of this review was to assess the clinical applications of creatine supplementation on paediatrics. Creatine metabolism disorders have so far been described at the level of two synthetic steps, guanidin...
Source: Current Pharmaceutical Biotechnology - September 12, 2009 Category: Biotechnology Authors: Athanasios E, Konstantina V, Paraskevi K, Nikolaos N Tags: Curr Pharm Biotechnol Source Type: journals

Momordica balsamina: A Medicinal and Neutraceutical Plant for Health Care Management.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Momordica balsamina, African pumpkin (Cucurbitaceae), is a tendril-bearing, wild climber containing wide spectrum of medicinal and nutritional values and has been used as a traditional folk medicine in many countries. The leaves, fruits, seeds, and bark of the plant contains resins, alkaloids, flavonoids, glycosides, steroids, terpenes, cardiac glycoside, saponins having various medicinal importance viz. anti-HIV, anti-plasmodial, shigellocidal, anti-diarrheal, anti-septic, anti-bacterial, anti-viral, anti-inflammatory, anti-microbial, antiviral, hypoglycemic, antioxidant, analgesic and hepatoprotective. The therapeuti...
Source: Current Pharmaceutical Biotechnology - September 12, 2009 Category: Biotechnology Authors: Thakur GS, Bag M, Sanodiya BS, Bhadouriya P, Debnath M, Prasad G, Bisen PS Tags: Curr Pharm Biotechnol Source Type: journals

Chlorophytum borivilianum: A White Gold for Biopharmaceuticals and Neutraceuticals.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Chlorophytum borivilianum Santapau & Fernandes (Liliaceae) also known as 'Safed Musli' is a traditional rare Indian medicinal herb which has many therapeutic applications in Ayurvedic, Unani, Homeopathic and Allopathic system of medicine. Its roots (tubers) are widely used for various therapeutic applications. It is used to cure physical illness and weakness, as an aphrodisiac agent and revitalizer, as general sex tonic, remedy for diabetes, arthritis and increasing body immunity, curative for natal and postnatal problems, for rheumatism and joint pains, increase lactation in feeding mothers, as antimicrobial, anti...
Source: Current Pharmaceutical Biotechnology - September 12, 2009 Category: Biotechnology Authors: Thakur GS, Bag M, Sanodiya BS, Debnath M, Zacharia A, Bhadouriya P, Prasad G, Bisen PS Tags: Curr Pharm Biotechnol Source Type: journals

Pharmacology and Chemistry of a Potent Hepatoprotective Compound Picroliv Isolated from the Roots and Rhizomes of Picrorhiza kurroa Royle ex Benth. (Kutki).Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Natural products from plants are of major pharmaceutical and therapeutic importance, several of which are often obtained from the underground parts of the concerned plants. Deviation from standard rules in modern medicines, where instead of a single isolated fraction, a group of naturally occurring components exerts the desired therapeutic effect, was noted in case of Picroliv or Kutkin of Picrorhiza kurroa. "Picroliv" mainly a glucoside, is one such compound, normally obtained from 3 - 4 years old roots and rhizomes of an endangered medicinal plant - Picrorhiza kurroa (kutki) and constitute an important component of m...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Verma PC, Basu V, Gupta V, Saxena G, Ur Rahman L Tags: Curr Pharm Biotechnol Source Type: journals

Microdialysis: A Technique for Pharmacokinetic-pharmacodynamic Studies of Oncological Drugs.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In conclusion, the role of MD in preclinical PK-PD studies of oncological drugs has been confirmed and it has provided a strong foundation for further clinical research. PMID: 19619119 [PubMed - as supplied by publisher] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Wei YH, Xu LZ, Shen Q, Li FZ Tags: Curr Pharm Biotechnol Source Type: journals

In silico Studies on Tryparedoxin Peroxidase of Leishmania infantum: Structural Aspects.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Tryparedoxin peroxidase (TryP) is a key enzyme of the trypanothione-dependent metabolism for removal of oxidative stress in leishmania. These enzymes function as antioxidants through their peroxidase and peroxynitrite reductase activities. Inhibitors of this enzyme are presumed to be antilesihmania drugs and structural studies are prerequisite of rational drug design. We have constructed three dimensional structure of TryP of Leishmania infantum using comparative modeling. Structural analysis reveals several interesting features. Moreover, it shows remarkable structural difference with human host glutathione peroxidase...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Singh BK, Dubey VK Tags: Curr Pharm Biotechnol Source Type: journals

Effects of pH and Arginine on the Solubility and Stability of a Therapeutic Protein (Fibroblast Growth Factor 20): Relationship between Solubility and Stability.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of this study was to dramatically enhance the solubility (> 400 fold) and stability of a therapeutic protein (Fibroblast Growth Factor 20) and to perform detailed biophysical characterization for the optimization of its formulation. The solubility of FGF-20 strongly depends on pH, arginine concentration and anions present in a buffer system. In the absence and presence of arginine, solubility was higher at lower pH (5 </= pH </= 6) and then decreased steadily with a minimum solubility at around pH 6.3 and plateaus at around pH 7.5 respectively. For a given pH, the protein was most soluble in argini...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Maity H, Karkaria C, Davagnino J Tags: Curr Pharm Biotechnol Source Type: journals

Preparation of Polymeric Carriers for Drug Delivery with Different Shape and Size Using an Electric Jet.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A method for generating poly(lactic-co-glycolic acid) and polycaprolactone biodegradable particles of different size and shape using a jet generated in an electric field is elucidated. These particles are suitable for use as drug carriers and the method can be developed into a mass production route. The effect of different parameters such as applied voltage, collecting distance, flow rate and polymer concentration on inducing size and shape differences for these particles was studied. It was found that the flow rate, polymer concentration and collecting distance have a significant impact on the size of the generated pa...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Enayati M, Ahmad Z, Stride E, Edirisinghe M Tags: Curr Pharm Biotechnol Source Type: journals

Tryptophan Fluorescence Quenching by Enzyme Inhibitors as a Tool for Enzyme Active Site Structure Investigation: Epoxide Hydrolase.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We present the strong fluorescence effect, a new 392 nm emission peak appearing after binding of a naphtol-urea inhibitor XIIa to the enzyme epoxide hydrolase (EH), along with the quenching of the EH tryptophan fluorescence. We have studied the quenching of the 392-nm peak (attributed to XIIa bound inside the active center of the enzyme) of the mixture EH +XIIa by various strong transparent inhibitors (competing with XIIa for binding to EH), and measured the corresponding values of the Stern-Volmer constants, K(mix)(SV). Strong EH inhibitors demonstrate different replacement behavior which can be used to distinguish them. ...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Matveeva EG, Morisseau C, Goodrow MH, Mullin C, Hammock BD Tags: Curr Pharm Biotechnol Source Type: journals

Cellular Uptake of Neutral Phosphorodiamidate Morpholino Oligomers.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Phosphorodiamidate morpholino oligomers (PMO), which have a neutral chemistry, are extensively being used as tools for selective inhibition of gene expression in cell culture models and are currently in human clinical trials. Unlike phosphorothioates (PS ODN) and other charged oligonucleotides, little is known about the uptake characteristics of neutral oligomers. The purpose of this study was to understand the kinetics of PMO transport in cells and correlate with antisense activity. In contrast to primary cells and some transformed cell lines which were uptake permissive, established cancer cell lines showed very poor...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Iversen PL, Aird KM, Wu R, Morse MM, Devi GR Tags: Curr Pharm Biotechnol Source Type: journals

Trafficking of Mature miRNA-122 into the Nucleus of Live Liver Cells.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The binding of superquencher molecular beacon (SQMB) probes to human single-stranded cellular miRNA-122 targets was detected in various single live cells with femtosecond laser microscopy. For delivery of the SQMB-probes, 3D-nanoprocessing of single cells with sub-15 femtosecond 85 MHz near-infrared laser pulses was applied. Transient nanopores were formed by focusing the laser beam for some milliseconds on the membrane of a single cell in order to import of SQMB-probes into the cells. In single cells of the human liver cell lines Huh-7D12 and IHH that expressed miRNA-122, we measured target binding in the cytoplasm by...
Source: Current Pharmaceutical Biotechnology - July 23, 2009 Category: Biotechnology Authors: Földes-Papp Z, König K, Studier H, Bückle R, Breunig HG, Uchugonova A, Kostner GM Tags: Curr Pharm Biotechnol Source Type: journals

Aggregation detection and removal biopharmaceutical proteins.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19519408 [PubMed - in process] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Gagnon P, Arakawa T Tags: Curr Pharm Biotechnol Source Type: journals

Mechanisms of protein aggregation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Aggregation or reversible self-association of protein therapeutics can arise through a number of different mechanisms. Five common aggregation mechanisms are described and their relations to manufacturing processes to suppress and remove aggregates are discussed. PMID: 19519409 [PubMed - in process] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Philo JS, Arakawa T Tags: Curr Pharm Biotechnol Source Type: journals

Immunogenicity assessment of therapeutic proteins and peptides.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Assessment of immunogenicity is a major aspect in evaluating the safety of biological therapeutic proteins. It is important to evaluate the immunogenic potential of the biologics in an appropriate fashion using clearly defined strategy and clinical trials. The studies must include the appropriate risk assessment procedures using validated methods. The immune responses against the therapeutic biologics can be studied using various methodologies. These include enzyme linked immunoassays (ELISA), surface plasmon resonance (SPR), chemiluminescence, and flowcytometry assays for binding antibodies and cell based assays for n...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Kaliyaperumal A, Jing S Tags: Curr Pharm Biotechnol Source Type: journals

A critical review of methods for size characterization of non-particulate protein aggregates.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Although size exclusion chromatography (SEC) has been, and will continue to be, the primary analytical tool for characterization of the content and size distribution of non-particulate aggregates in protein pharmaceuticals, regulatory concerns are driving increased use of alternative and complementary methods such as analytical ultracentrifugation and light scattering techniques. This review will highlight and critically review the capabilities, advantages, and drawbacks of SEC, analytical ultracentrifugation, and light scattering methods for characterizing aggregates with sizes below about 0.3 microns. The physical pr...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Philo JS Tags: Curr Pharm Biotechnol Source Type: journals

A critical review of analytical methods for subvisible and visible particles.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article will focus on methods for analyzing and quantitating sub visible particles (SbVP) of 2 microns or larger. At the present time there is no routine method for quantitating sub visible particles (SbVP) between 0.1 microns and 2 microns. The most common technique for quantitating the amount of subvisible particles between 2 and 100 microns is the light obscuration method. This technique can determine size and amount of particles, but cannot differentiate between the types of particles, such as protein particles, foreign material, micro bubbles or silicone oil droplets, that can be present in protein solutions. The...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D Tags: Curr Pharm Biotechnol Source Type: journals

Separation and characterization of protein aggregates and particles by field flow fractionation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Field flow fractionation (FFF) is a technique that holds great promise for the analysis and characterization of protein aggregates and particles, due to its wide dynamic range and matrix-free separation mechanism. FFF can be routinely used to achieve good monomer-oligomer separation and quantification for a variety of protein types, and is a reasonable choice for an orthogonal method for size exclusion chromatography and analytical ultracentrifugation. Quantifying sub-micrometer particles in protein therapeutics is a potential of the FFF technique that is yet to be realized, due to the lack of detection with sufficient...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Cao S, Pollastrini J, Jiang Y Tags: Curr Pharm Biotechnol Source Type: journals

Application of vibrational spectroscopy to the structural characterization of monoclonal antibody and its aggregate.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Aggregation is often the major issue during formulation and manufacturing development of therapeutic proteins, in particular human monoclonal antibody. Currently, there is a lack of structural information of aggregates of such large protein as human antibodies, due to the large molecular sizes of the aggregates. In this article, we shall discuss the application of vibrational spectroscopies including FT-IR, Raman and Raman Optical Activity (ROA), to characterize the structures of various types of monoclonal antibody aggregates formed under different stresses. Two different classes of human monoclonal antibodies, namely...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Li CH, Li T Tags: Curr Pharm Biotechnol Source Type: journals

Effect of additives on protein aggregation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This paper overviews solution additives that affect protein stability and aggregation during refolding, heating, and freezing processes. Solution additives are mainly grouped into two classes, i.e., protein denaturants and stabilizers. The former includes guanidine, urea, strong ionic detergents, and certain chaotropic salts; the latter includes certain amino acids, sugars, polyhydric alcohols, osmolytes, and kosmotropic salts. However, there are solution additives that are not unambiguously placed into these two classes, including arginine, certain divalent cation salts (e.g., MgCl(2)) and certain polyhydric alcohols ...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Hamada H, Arakawa T, Shiraki K Tags: Curr Pharm Biotechnol Source Type: journals

Suppression of protein aggregation by L-arginine.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article aims at giving a brief overview about the discovery of the arginine effect, the range of its applications that have been explored over the past two decades, and of the current state of the discussion regarding the mechanisms responsible for the action of L-arginine as suppressor of aggregation. PMID: 19519416 [PubMed - in process] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Lange C, Rudolph R Tags: Curr Pharm Biotechnol Source Type: journals

To be excluded or to bind, that is the question: Arginine effects on proteins.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In spite of its wide application to protein refolding, purification, and storage, we have not yet addressed a general solution to the mechanism of the effects of arginine hydrochloride on proteins. To elucidate the mechanism of the effects on proteins, several attempts have been reported. In this review, we would review the attempts from thermodynamic and kinetic viewpoints. PMID: 19519417 [PubMed - in process] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Nakakido M, Kudou M, Arakawa T, Tsumoto K Tags: Curr Pharm Biotechnol Source Type: journals

Ion exchange chromatography of proteins and clearance of aggregates.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Clearance of product related aggregates in therapeutic proteins is a major focus of purification process development. A typical purification process will have one or two chromatographic steps that remove these product related aggregates to an acceptable level. Both cation exchange and anion exchange chromatography can provide robust clearance of aggregates. The primary factors that are critical for aggregate clearance are: resin chemistry, binding and elution condition, peak collection and column load factor. This review covers how these factors can be optimized to increase the effectiveness of ion exchange chromatogra...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Yigzaw Y, Hinckley P, Hewig A, Vedantham G Tags: Curr Pharm Biotechnol Source Type: journals

Recent advancement in application of hydrophobic interaction chromatography for aggregate removal in industrial purification process.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Hydrophobic interaction chromatography (HIC) is a classic purification tool applied in protein and antibody, laboratory and industrial production process. It has been mainly used for the removal of both product-related impurities such as aggregates, as well as process contaminants such as host cell proteins. This review will focus on the recent development of HIC in its applications in the industrial purification processes. The process economy and requirements of high product purity and quality have driven much of the recent advancement in HIC chromatography in terms of increased throughput and enhanced selectivity or ...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Lu Y, Williamson B, Gillespie R Tags: Curr Pharm Biotechnol Source Type: journals

IgG aggregate removal by charged-hydrophobic mixed mode chromatography.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Charged-hydrophobic mixed mode chromatography methods have been applied to antibody purification for decades and have focused more recently on the specific task of aggregate removal. They exploit various combinations of alkyl and aromatic hydrophobic groups with positively and/or negatively charged residues. Charge and hydrophobicity remain relatively constant as function of pH for some ligands; one or both vary for others. All of these compound selectivities and their associated elution strategies are intended to achieve purification of native IgG through preferential retention of aggregates. This review focuses on th...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Gagnon P Tags: Curr Pharm Biotechnol Source Type: journals

Antibody aggregate removal by hydroxyapatite chromatography.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Hydroxyapatite (HA) has proven in recent years to be one of the most versatile and powerful methods for removing aggregates from antibody preparations. It is effective with IgA, IgG and IgM, and it reduces aggregate levels from above 60% to less than 0.1%. Three basic elution strategies have evolved, one that removes aggregates from a modest proportion of clones, another from the majority, and one that appears to be universally effective. Each has distinct development and process ramifications. This review defines what HA is, how it interacts with various classes of biomolecules, how those interactions are controlled b...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Gagnon P, Beam K Tags: Curr Pharm Biotechnol Source Type: journals

Application of high hydrostatic pressure to dissociate aggregates and refold proteins.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Non-denaturing pressures of around 2000 bar are effective for eliminating and refolding protein aggregates and may be applicable in various phases of protein manufacturing to decrease aggregate levels in products and improve process yields. Lower aggregate levels can result in reduced immunogenicity of proteins and enable the correct refolding of proteins that might not be recovered with traditional techniques. High pressure treatment can also be used to conduct selective PEGylation and protease cleavage reactions while minimizing protein aggregation. High pressure processes have been used in the food industry for over...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Seefeldt MB, Rosendahl MS, Cleland JL, Hesterberg LK Tags: Curr Pharm Biotechnol Source Type: journals

Stress-free chromatography: affinity chromatography.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A number of approaches are available in minimizing aggregation of the final protein products. This chapter describes one such approach, i.e., an attempt to avoid stressful conditions that may eventually lead to protein aggregation. Affinity chromatography uses specific interaction between protein to be purified and ligand attached to the column. Due to high affinity, dissociation of such interaction and hence elution often require harsh solvent conditions. Ion exchange and hydrophobic interaction chromatography also pose certain stressful conditions on proteins. Here we describe development of mild elution buffer using...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Arakawa T, Kita Y, Sato H, Ejima D Tags: Curr Pharm Biotechnol Source Type: journals

Stress-free chromatography: IEC and HIC.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Ion exchange chromatography (IEC) poses stresses on proteins in both binding and elution steps. Proteins often bind to the column with high affinity, resulting in concentration of the protein upon binding. Elution often requires high salt concentration, leading to high protein concentration with high salt concentration. Although hydrophobic interaction chromatography (HIC) involves weak interaction, salting-out salts are used for binding. These conditions may cause protein aggregation. This short article describes an approach to reduce such aggregation in IEC and HIC. This was achieved by adding small amount of salt or...
Source: Current Pharmaceutical Biotechnology - May 31, 2009 Category: Biotechnology Authors: Arakawa T, Kita Y, Ejima D Tags: Curr Pharm Biotechnol Source Type: journals

The calcium-sensing receptor: pathophysiology and pharmacological modulation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19355936 [PubMed - in process] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Armato U Tags: Curr Pharm Biotechnol Source Type: journals

Regulation of cellular signal transduction pathways by the extracellular calcium-sensing receptor.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The extracellular calcium-sensing receptor (CaR) is a class III G-protein coupled receptor that coordinates cellular responses to changes in extracellular free Ca(2+) or amino acid concentrations as well as ionic strength and pH. It regulates signalling cascades via recruiting and controlling the activities of various heterotrimeric G-proteins, including G(q/11), G(i/0), and G(12/13), even G(s) in some "unusual" circumstances, thereby inducing changes in the metabolism of membrane lipids, the phosphorylation state of protein kinases and their targets, the activation state of monomeric G-proteins and the levels of intra...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Brennan SC, Conigrave AD Tags: Curr Pharm Biotechnol Source Type: journals

Expression and role of the calcium-sensing receptor in the blood vessel wall.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The calcium-sensing receptor (CaSR), which is involved in systemic calcium homeostasis, has also been found to be functionally expressed on cells of the vascular wall. Its activation on perivascular nerves and endothelial cells has been shown to regulate arterial tone, peripheral vascular resistance and possibly local tissue perfusion. The expression of the CaSR on immune cells involved in vascular inflammation, such as macrophages, and its increased expression in inflammation indicates the central role extracellular calcium plays in vascular inflammation and repair. Further detailed analysis will clarify the role the ...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Molostvov G, Bland R, Zehnder D Tags: Curr Pharm Biotechnol Source Type: journals

The role of the calcium-sensing receptor in bone biology and pathophysiology.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We present the evidence for a non-redundant role for CaR in skeletal mineralization, including our experience in patients with activating CaR mutations. Additionally, we review emerging research on the importance of the CaR to the regulation of serum calcium homeostasis independent of PTH, the role of the CaR in the hematopoietic stem cell niche with implications for bone marrow transplant, and early evidence that implies a role for the CaR as a factor in skeletal metastasis from breast and prostate cancer. We conclude with a discussion of drugs that target the CaR directly either as agonists (calcimimetics) or antagonists...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Theman TA, Collins MT Tags: Curr Pharm Biotechnol Source Type: journals

Roles of calcium-sensing receptor (CaSR) in renal mineral ion transport.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Calcium-sensing receptor (CaSR), a member of family C of the G protein-coupled receptors, is expressed most abundantly in the parathyroid glands and kidney. It plays key role in these two organs because it senses changes in extracellular calcium and regulates PTH secretion and calcium reabsorption to suit the extracellular calcium concentration. In kidney, CaSR is expressed in all nephron segments. It has an inhibitory effect on the reabsorption of calcium, potassium, sodium and water, depending on the particular function of the different tubular tracts. Among its inhibitory effects, CaSR modulates the signaling pathwa...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Vezzoli G, Soldati L, Gambaro G Tags: Curr Pharm Biotechnol Source Type: journals

The calcium-sensing receptor--a driver of colon cell differentiation.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dietary Ca(2+) reduces colon cell proliferation and carcinogenesis, but it becomes ineffective or even tumor-promoting during carcinogenesis. It appears that Ca(2+) and the colon cell CaSR together brake the massive cell production in normal colon crypts. The rapid proliferation of the transit-amplifying (TA) progeny of the colon stem cells at the bases of the crypts is driven by the "Wnt" signaling mechanism that stimulates proliferogenic genes and prevents apoptogenesis. It appears that TA cell cycling stops and terminal differentiation starts when the cells reach a higher level in the crypt where there is enough ext...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Whitfield JF Tags: Curr Pharm Biotechnol Source Type: journals

Calcium-sensing receptor (CaSR) in human brain's pathophysiology: roles in late-onset Alzheimer's disease (LOAD).Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Although the calcium-sensing receptor (CaSR) is expressed by all types of nerve cells in widespread areas of the human central nervous system (CNS), so far its roles in brain pathophysiology remain largely unknown. Here, we review the available evidence concerning the stages of development of sporadic late-onset Alzheimer's disease (LOAD) and the roles therein played by CaSR signaling. As the brain ages, its ability to dispose of dangerous synapse-targeting soluble amyloid beta-(1-42) (sAbeta42) oligomers released from normal neuronal activity declines. As their levels slowly rise, these oligomers increasingly target a...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Chiarini A, Dal Pra I, Marconi M, Chakravarthy B, Whitfield JF, Armato U Tags: Curr Pharm Biotechnol Source Type: journals

Umbilical cord stem cell: an overview.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In recent years, human umbilical cord blood (HUCB) has emerged as an attractive tool for cell-based therapy. Although at present the clinical application of human umbilical cord blood is limited to the fields of hematology and oncology, a rising number of studies show potential for further application in the treatment of non-hematopoietic diseases. Stem cells (SC) from umbilical cord blood (UCB) are now a new reliable alternative to treat different blood diseases, if the samples are frozen at the moment of birth. This procedure is an easy and safe way to preserve genetic materials for future therapeutic uses. It can be...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Ruhil S, Kumar V, Rathee P Tags: Curr Pharm Biotechnol Source Type: journals

Multiple myeloma bone marrow niche.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
"Niche" is defined as a specialized regulatory microenvironment, consisting of components which control the fate specification of stem and progenitor cells, as well as maintaining their development by supplying the requisite factors. Bone marrow (BM) niche has a well-organized architecture and is composed of osteoblasts, osteoclasts, bone marrow endothelial cells, stromal cells, adipocytes and extracellular matrix proteins (ECM). These elements play an essential role in the survival, growth and differentiation of diverse lineages of blood cells, but also provide optimal growth environment for multiple hematological mal...
Source: Current Pharmaceutical Biotechnology - April 1, 2009 Category: Biotechnology Authors: Basak GW, Srivastava AS, Malhotra R, Carrier E Tags: Curr Pharm Biotechnol Source Type: journals

The utilization of gene targeting models during in preclinical study of drug discovery process--example of phenotypic and functional analysis of Cacna1beta gene product.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Using gene knockout mice of particular genes is one of the most effective methods in conducting successful study on the mode of action of target gene products in targeted organs. So called the knockout technology is now a powerful tool that can lead us to find clear understanding on difficult questions such as the effects of full antagonist against target molecules. Cacna1b (alpha(1B)) gene knockout mouse was generated to study mechanisms of N-type calcium (Ca(2+)) channel. The model was able to overcome physiological obstacles in studies of N-type Ca(2+) channel selective blockers, such as unspecific binding to struct...
Source: Current Pharmaceutical Biotechnology - February 1, 2009 Category: Biotechnology Authors: Miyamoto N, Namiki K, Tokuhara N, Uesugi M, Takahashi E, Kuromitsu J, Kasuya Y Tags: Curr Pharm Biotechnol Source Type: journals

Novel targets in cancer therapy.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
PMID: 19199945 [PubMed - in process] (Source: Current Pharmaceutical Biotechnology)
Source: Current Pharmaceutical Biotechnology - February 1, 2009 Category: Biotechnology Authors: Banerjee D Tags: Curr Pharm Biotechnol Source Type: journals

Potential novel targets in breast cancer.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This review focuses on the properties of different breast cancer cell subsets, including cancer stem cells (CSCs) and cancer progenitors. The premise is that an understanding of self-renewal, the effects of aging microenvironment on the behavior of cancer cell subsets will map the path of development from CSCs to progenitors. The basic characterization of different cancer cell subsets will lead to their signatures and open the field to novel methods of prognosis and diagnosis. The identification of cancer progenitors would allow scientists to modify the cells genetically for de-differention to CSCs. This will benefit t...
Source: Current Pharmaceutical Biotechnology - February 1, 2009 Category: Biotechnology Authors: Rameshwar P Tags: Curr Pharm Biotechnol Source Type: journals

Notch inhibitors as a new tool in the war on cancer: a pathway to watch.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Notch was first recognized as an important developmental pathway in Drosophila in the first half of the 20(th) century. Many decades later, this pathway has been found to play central roles in humans in stem cell maintenance, cell fate decisions, and in cancer as well. Notch family members are being revealed as oncogenes in an ever-increasing number of cancers. Though significant progress has been made in dissecting the complex workings of this signaling pathway, there are very limited options available for Notch inhibitors. However, the pioneering class of Notch inhibitors is already in clinical trials for two cancer ...
Source: Current Pharmaceutical Biotechnology - February 1, 2009 Category: Biotechnology Authors: Purow B Tags: Curr Pharm Biotechnol Source Type: journals