August 2011

Viral Clearance Services at Lancaster Laboratories

The risk of viral contamination is a feature common to all biotechnology products produced by processes that use cell lines and raw materials of animal origin. Such contamination could have serious clinical consequences, and worldwide regulatory bodies expect that the viral safety of these products be ensured. Viral clearance studies are performed as one way of demonstrating viral safety. The studies are executed by intentionally adding or “spiking” large amounts of virus into the starting material for individual manufacturing steps…

Maximizing Gas-Transfer in Small-Scale Cultures

Research and early process development generally rely heavily on screening and examination of cultures grown in microtiter and shake-flasks. Unfortunately, the growth environment in these formats is extremely different from the bioreactor conditions used in larger-scale production. This application note describes two tools for improving growth conditions at these scales. Theµ-Flask: Cultures grown in traditional microplates are usually sealed using simple plastic lids or adhesive tape seals. Such systems suffer from well-to-well variability, poor gas transfer, excessive evaporation, and cross-contamination.…

Formulation and Fill for a Vaccine with Alum Adjuvant

The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The Outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time. About…

Expression of a Fab Fragment in Pfēnex Expression Technology™

          The Pfēnex Expression Technology™ platform is a powerful protein Expression Technology based on the novel host Pseudomonas fluorescens. Legacy recombinant protein expression hosts such as E. coli and yeast tend to have high failure rates with regard to expression of soluble, active protein. In addition, the time required to identify the optimal expression strain in these systems is protracted, resulting in significant opportunity cost for drug developers. Leveraging the Pfēnex Expression Technology™ shortens development time…

Performance Characterization of Batch-Fed Nonadherent CHO Cell Culture in Rocker Bags

Disposable cell culture bags are used in conjunction with rocker platforms in an array of cultivation applications (insect and mammalian cell lines, virus, protein expression). Rocking platforms provide the dynamic motion and oxygen transfer for cell culture environments. Disposable culture bags are designed to allow for a large air-liquid surface for oxygen transfer, easy access for sampling/filling, and a sterile environment. Venting issues have been reported in the field during rocking of disposable cell culture bags. Therefore, venting and cell…

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…