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Preformulation Development of a Recombinant Targeted Secretion Inhibitor
Our company carried out a preformulation study on a recombinant targeted secretion inhibitor (TSI) with contract research organization (CRO) Avacta Analytical. In this protein, the binding domain of...
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Tunable Half-Life Technology
While a constantly developing market puts increasing pressure on pharmaceutical companies to provide advanced and personalized therapies, the industry is investing heavily in the development of...
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Drug Products for Biological Medicines
Traditionally, the CaSSS CMC Strategy Forum meetings have provided a scientific focus on the development of biotech drug substances and their manufacture and characterization, leaving the development...
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“Transformation By Infection”
Every bioprocess begins with an expression system, and every expression system begins with DNA transfection. Derived from transformation and infection, the word paradoxically has come to be applied...
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Development of Protein Capsular Matrix Vaccine Platform Technology
Polysaccharide vaccines account for about 30% of the total >$20-billion/year vaccine market. Despite efficacious vaccines in the field, diseases such as invasive Streptococcus pneumoniae and...
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Highly Concentrated Protein Formulations: Finding Solutions for the Next...
Therapeutic protein formulation is no easy task. Biological drugs may be destined for prefilled syringes or glass vials, or they may be made into lyophilized powders that will be reconstituted in a...
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Evaluation of a Variable-Pathlength Spectrophotometer: A Comparable...
WWW.PHOTOS.COM Protein concentrations in bioprocessing are determined by multiplying the measured absorbance of UV light as it passes through a sample by the protein extinction coefficient....
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Development of a High-Throughput Formulation Screening Platform for...
The goal of formulation development for therapeutic proteins is to find conditions under which a protein remains stable during storage, transport, and delivery to patients. Both chemical and physical...
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Biophysical Analysis: A Paradigm Shift in the Characterization of...
www.photos.com Generating a stable environment for a biopharmaceutical drug substance is a critical step for ensuring a long drug-product shelf life (1–6). This process begins early in development with...
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Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass...
Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the...
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Outsourcing Stability Testing: Discussions with Contract Laboratories
BIORELIANCE (WWW.BIORELIANCE.COM/US) Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of...
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Rapid Formulation Development for Monoclonal Antibodies
WWW.PHOTOS.COM Monoclonal antibodies (MAbs) are at the focal point of biologics development. Many of the best-selling drugs are therapeutic MAbs or related proteins (1–2). The combined world-wide sales...
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Validation of Controlled Freezing and Thawing Rates: A 16-L–Bag Study
Photo 1: Standard one-bag position in chamber It is well understood that freeze– thaw processes affect the product quality of biopharmaceuticals (1–3). It has been reported that there is no consistent...
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Critical Factors for Fill–Finish Manufacturing of Biologics
In perspective: aspirin (upper left, front), somatropin (middle molecule), and an antibody (lower right, back) — to approximate scale — molecular models from Wikicommons Over recent decades,...
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Ask the Expert Liposome and Viral Vector Characterization: Use of Electron...
with Dr. Josefina Nilsson For this webcast, Josefina Nilsson (EM Services business unit head) discussed Vironova’s work, including case studies. She focused on characterization of drug and gene...
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Osmolality Measurements for High-Concentration Protein–Polymer Solutions:...
BRISTOL-MYERS SQUIBB (WWW.BMS.COM) Osmolality is a critical attribute for injectable formulations. It is desirable to have products match physiological osmotic conditions. Furthermore, osmolality...
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Investigation of Foreign-Particle Contamination: Practical Application of...
Figure 1: Absorbance Fourier-transform infrared (FT-IR) spectra of different test articles made of polypropylene The presence of visible foreign particulate matter is considered a critical defect in...
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Aggregation from Shear Stress and Surface Interaction: Molecule-Specific or...
WWW.PHOTOS.COM Exposure to solid–liquid and air–water interfaces during production, freezing and thawing, shipment and storage of protein therapeutics may be a contributing factor in their degradation...
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Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass...
Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the...
View ArticleClik here to view.
Outsourcing Stability Testing: Discussions with Contract Laboratories
BIORELIANCE (WWW.BIORELIANCE.COM/US) Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of...
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