July 2010

Maximize Protein Expression in CHO Suspension Cells

          Transient transfection in mammalian cell lines provides an avenue for researchers to bridge the development bottleneck and shorten the time to usable protein. The method also maintains post translational modifications crucial for biotherapeutic function. Chinese hamster ovary (CHO) suspension cells are especially suited for high-yield production of recombinant proteins, despite being refractory to commonly used transfection methods (e.g., 25-KDa linear PEI). Mirus Bio has developed a more effective alternative, the TransIT-PRO™ transfection kit. Using this…

SAFC Centers of Excellence for Liquid and Powder Manufacturing

Biopharmaceutical manufacturers are under increasing pressure to improve efficiency while maintaining consistent quality and supply of raw materials. SAFC has supplied the top 20 global biopharmaceutical companies for 30 years with custom-made solutions to complex challenges in the manufacture of monoclonal antibodies, recombinant proteins and vaccines. SAFC simplifies the complex task of supplying critical raw materials for your process with worldwide distribution channels and warehousing to ensure inventory where and when you need it. Packaging, testing, and labeling are customized…

Development and GMP Manufacturing of Biopharmaceuticals

With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany). Preclinical to Commercial Supply Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm…

Cell Harvesting of Biotechnological Processes By Depth Filtration

          In the pharmaceutical industry, there is a strong desire to introduce new drugs on the market as fast as possible (time-to-market) due to time-limited patent protection for new pharmaceutical products. The thinking behind this desire is simple: the sooner a new product can be introduced to the market, the sooner patients can benefit, and the better are the manufacturer’s prospects of financial returns. This consideration, however, should not allow compromises to enter into the manufacturing…

CelliGen® BLU Single-Use, 5-L and 14-L Bioreactor

          Whether you are culturing animal cells in an R&D laboratory or in a pilot production facility, your ability to precisely control all process parameters is critical. Culture yield depends on it, and should your process go into production, FDA requirements mandate it. Therefore the performance of your bioreactor’s controller is as important as a good vessel design, as an optimized medium formulation, or selection of the right cell line. This article focuses on the process…

Performance Enhancing Synergy

          In an effort to mitigate potential risks associated with the introduction of adventitious agents from animal-derived media components, the biopharmaceutical industry has largely shifted to serum-free and/or chemically defined media in cell culture production systems. Successful serum-free media formulations have been developed using plant-derived protein hydrolysates in combination with recombinant supplements such as insulin, transferrin, and human serum albumin, produced in nonanimal systems. The performance benefit provided by any medium supplement is subject to its…

New Therapeutics Through Fermentation Technology

          Applications of microbial fermentation technology in new therapeutics are expanding. SAFC offers unique cGMP fermentation-based manufacturing capabilities through its Jerusalem facility, including highly potent APIs and biologics. SAFC scientific teams provide a complete range of services, including process evaluation and development, optimization and scale up, technology transfer, manufacturing, analytical testing and regulatory filing to help customers bring new drugs to market faster. SAFC is finding new applications for its expertise in fermentation technology, including the…

An Improved Performance Affinity Adsorbent

          Albumin and albumin-related proteins such as albumin fusion proteins represent an increasingly important platform for production of therapeutic proteins with extended in vivo half-lives. Affinity ligands directed to the albumin portion of the molecule are ideally suited to development of a purification platform for albumin containing proteins. In addition, significant reductions in manufacturing costs are possible, especially if processing times can be shortened through use of higher flow rates.   Introduction   Mimetic Blue® SA…

Single-Use Bioreactors with Unparalleled Mixing, Scalability, and Ease of Use

        PBS 3-L benchtop bioreactor ()   PBS Biotech has emerged into the growing single-use bioprocessing space with an offering truly unlike any other: elegant, powerful, and incredibly easy-to-use bioreactors. A commitment to quality and innovation is evident in every design element of PBS Biotech’s Pneumatic Bioreactor System™. The proprietary Air-Wheel™ agitation mechanism powered by gas buoyancy provides unparalleled mixing performance for cell cultivation. The result is rapid liquid mixing, efficient mass transfer, and significantly lower shear…

AAIPharma Services Corp.

          For more than 30 years, AAIPharma Services has provided drug product development services to pharmaceutical, biotechnology, and medical device companies around the world. Our team of 400+pharmaceutical scientists and professionals, including 20 PhDs, pride themselves on providing solutions to the most difficult drug development and manufacturing challenges. We have developed drugs in all major therapeutic areas, have had our work included in over 500 INDs, and currently provide services in support of more than 50…