As production facilities strive for greater efficiency, a common practice is to seek process improvements in quality control (QC) operations. All production facilities share some common requirements for these QC checks, especially that they can be fast, simple, proven, and economical. In addition to this, the production of biological materials such as proteins frequently presents additional requirements, including the need to perform QC tests using very small volumes and the ability to measure the protein…

          The complete characterization and analysis of biopharmaceuticals includes the application of size- exclusion chromatography (SEC) to measure protein aggregates and other size variants. Soluble protein aggregates in particular can contribute to immunogenicity. Accurate analysis and quantitation of biotherapeutic protein aggregates is therefore often required. Current HPLC/silica-based SEC methods can be time- consuming and unreliable. Their uncertain results may be due to changes in retention time, peak shape, or spacing between peaks as well as irreproducibility…

The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices, and components used in product manufacturing. Packaging includes components such as vials, caps, and stoppers. Drug delivery devices include nebulizers and inhalers. Components used during product manufacturing include filters, tubing, fittings, connectors, bioprocess bags, and bioreactors. Lancaster laboratories provides support by performing extractables and leachables testing. Extractables are compounds that can be extracted from a…

FrieslandCampina Domo, a division of the Ingredients Business Group of Royal FrieslandCampina BV, is one of the operating companies formed as a result of the merger between Friesland Foods and Campina in January 2009 to form Royal FrieslandCampina. Royal FrieslandCampina is a leading global multinational company, with 22,000 employees and revenues of over 9 billion Euros. Formerly Known As DMV International The operating company FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods…

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…