August 2011

Helium Integrity Testing (HIT™) for 2-D Bioprocessing Vessels

Technology Innovation ATMI® is an acknowledged technology leader in the development and manufacture of single-use bioprocess systems and consumables. Its innovative disposable technologies, best-of-breed polymer films, ultraclean ISO Class 5 manufacturing conditions and whole-bag integrity testing set a high bar for the single-use industry. Today, ATMI is raising the bar even higher with the introduction of Helium integrity Testing (HIT™). Helium Integrity Testing ATMI’s patent-pending HIT technology allows each ATMI 2-D Bioprocess vessel (BPV) to be tested for defects that…

Your Partner for Quality Protein Hydrolysates

FrieslandCampina Domo is a subsidiary of the dairy multinational Royal FrieslandCampina, which has 20,000 employees, active in over one hundred countries. Our revenues are over 9 billion Euros. Formerly Known as DMV International FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods Domo. These entities have over 75 years of experience in ingredient discovery, development, and marketing. With a new name and an expanded product portfolio, FrieslandCampina Domo is strengthening the presence in…

Bench to Bedside

Over the past decade, the cell therapy field has matured into the next generation of medical technology. In both the United States and the European Union, physicians now have an option to write prescriptions for manufactured engineered cell therapeutics, as they routinely do for prescription medications. And the number of available commercial cell therapies is expected to grow. However, unlike traditional pharmaceuticals, engineered cell therapeutics require geographically dispersed networks of cell collection, engineering, manufacture, distribution logistics, and treatment facilities, thus…

Capacity to Accelerate Success

As a CMO partner, Avid Bioservices provides fully integrated services across the process chain to develop and commercialize a biologic including cell line and process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory submissions. We provide first-hand expertise and knowledge to navigate a biologic from concept to commercialization because we are a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage, publicly traded biotech company with a management team experienced in the development and commercialization of therapeutic proteins.…

A CMO’s Approach

          Industry leading biologics contract manufacturer Fujifilm Diosynth Biotechnologies located in Research Triangle Park, NC (formerly Diosynth Biotechnology) and in Billingham, UK (formerly Avecia Biologics) provides third-party contract development and manufacturing services to the biopharmaceutical industry. Fujifilm Diosynth Biotechnologies has supplied clinical and commercial recombinant proteins produced in cell culture for more than 14 years. We have extensive experience in microbial development and manufacturing and equal experience in the cell culture space. Our development experience includes…

Unique Competence in Biopharmaceuticals

          Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 35 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 650. As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of…

Experience Makes the Difference

BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support your commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face. Experience Makes the Difference: With 80 years of parenteral expertise, we can help to navigate the pathway of success for your molecule. As a dedicated CMO with over 20 years of experience devoted to our customers’ clinical and commercial success,…

Improved Capture with Better Productivity in MAb Bioprocessing

Growing commercial demand for therapeutic monoclonal antibodies (MAbs) has increased the need for efficient and cost-effective manufacturing processes. The development of cell cultures with very high expression levels is one clear example. over recent years, the antibody titers of mammalian cell culture have risen dramatically, and today we often see titers of 5–10 g/L. Expression levels as high as 15 g/L or greater have even been reported. Chromatography media (resins) that can capture these high-titer antibodies are therefore essential for…

OPUS™ Prepacked Chromatography Columns with CaptivA™ PriMab™ Protein A Resin Speed Time-to-Market

Repligen™ OPUS (open Platform User Specified) prepacked columns packed with CaptivA™ PriMab™ Protein A resin offer high performance and all the advantages of single-use technology (reduced validation effort, reduced risk, faster time-to market). What makes this solution truly unique, however, is that oPUS prepacked columns provide lower total cost of ownership in many applications compared with conventional stainless steel or glass columns. Single-Use Chromatography Study BioPharm Services ltd (Chesham, UK) conducted a study to assess the impact on total cost…

BD Recharge™

Peptones have a long history of use in cell culture media. However, increasing emphasis has been placed on growing cells in animal-free and chemically defined systems for the production of biopharmaceuticals. This has created a demand for cell culture media supplements that equal the performance of peptones but have greater certainty of composition. This demand prompted BD’s efforts to identify the functional components of yeast extract to develop a chemically defined supplement, BD recharge. Formulation The keys to making a…