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…

          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…

          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…

          Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll…

Biotech companies appreciate the challenges involved in raising sufficient investment to support their drug development pipelines. In today’s economic conditions, it is even more critical that burn rates are minimised along with risks to achieving major product development and clinical milestones. Having reached the preclinical stage, the strategic decision whether to build in-house capability or outsource biopharmaceutical manufacturing will have been made. Limitations with investment is the main factor that will direct most companies to seek the services of a…

Avid Bioservices offers a fresh approach to the Contract Manufacturing organization (CMO)–client relationship: fully integrated services across the process chain, including cell line and process development, analytical methods development, cGMP manufacturing, fill/finish, regulatory submission, and commercialization of biologic drug product or drug substance. our expertise enables our clients to succeed in their ventures. As a wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage biotech company with a management team experienced in the commercialization of therapeutic proteins, we know what it…

          As the demand for plasmid DNA (pDNA)–based gene therapy and vaccines increases, large-scale, cost-effective, and reproducible pDNA production will be required. The key to success is a real-time, in-process control method that ensures a high percentage of supercoiled pDNA in the final product. CIMac pDNA Analytical Column allows the monitoring of degradation products (open circular and linear pDNA), the removal of impurities (RNA), and the assurance that each production step is yielding the amount of…

          Mycoplasma contamination of cell culture (both of primary and continuous eukaryotic cell lines) is common and represents a significant issue of importance in the basic research, development, and production of biologicals. Contamination can alter virtually every physical and chemical property of cells (depending on the contaminating species and the cell type), potentially leading to unreliable results and perhaps unsafe biologicals, biopharmaceutical drugs, or viral vaccines. In fact, contamination may be present with no obvious change…

          The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell…

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its comprehensive portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With over 250 different biomolecules successfully supported annually, Covance Biopharmaceutical Services provide…