Biologic Drugs

Industry, FDA, and World Health Agencies Boost Pandemic Preparedness

Collaboration Targets Single-Shot Japanese Encephalitis Vaccine

A fleet of pharmaceutical manufacturers have green lighted new bar coding and e-pedigree pilots using electronic barcodes. But is Industry ready for full-scale RFID?

Contract manufacturers serving the biopharmaceutical market add capacity in a bet on renewed growth for biomanufacturing.

Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.

Microbioreactor Array System Boost Cell Culture Capacity

Protein Refolding Technology Improves Yields

Can macromolecular processes learn from small-molecule experience? Burdened by exploding bioreactor productivity, architects of downstream bioseparation technology are looking into the drug industry's past for inspiration, while small-molecule companies adopt techniques pioneered by biotechnology. (The first of three articles on the current state of separations.)

FDA Posts Q5E Biotech and Biological Products Comparability Guideline

Vaccine developers are using novel drug delivery methods that offer advantages over traditional techniques such as improved immunogenicity, better stability, specific control over antigen release, and a wider pool of targeted diseases.

Pure water is a raw material of particular importance to the pharmaceutical industry. Drinking water is the basis for the treatment of water for pharmaceutical applications; it is the starting point for the production of the various pharmaceutical water qualities, such as purified water, highly purified water and water for injection.

Crucell and NIH Sign Ebola Vaccine Manufacturing Contract

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

ISA-88 Automation Standard Gains IEC PAS Status

Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.

Single-use products enhance sterile filtration by making it easier to maintain sterility and reduce cross-contamination risks.

The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.

The authors establish a quantitative framework for understanding the correlation between the segregation of pharmaceutical powders and various physical and process parameters.

Single-use filtration technology is becoming increasingly popular as manufacturers seek to cut costs and minimize processing times.

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

Sterilizing grade filters are widely used in the biopharmaceutical industry and were once thought of as being perfect. However, these filters have experienced rapid developments and improvements during the last decade, which have resulted in enhanced thermal and mechanical resistance. Moreover, their performance levels have been raised, which has led to significant cost savings within production processes.

Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.

In this study, the authors examine the suitability of 0.45 &#181m&#150rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.

Special considerations and cautions must be adhered to when designing virus safety studies and developing appropriate virus contamination control programs.