Author Archives: BPI Contributor

Safety Considerations for Gas Filtration in High-Temperature and Oxygen Enrichment Applications

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Gas filtration using sterilization-grade filters is a key part of the production, manufacturing and packaging process of biopharmaceuticals and other products. While it may seem a simple step, there are major safety considerations that have to be taken in to account to protect staff, equipment and facilities from hazard, particularly when working in high temperature and oxygen enrichment applications. This paper examines the safety issues involved, looks at material design considerations and introduces a ready-made solution for safe, effective, robust…

August 5, 2015

BioOutsource Opens New Facility in Glasgow

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BioOutsource Ltd. (“BioOutsourceâ€), part of Sartorius Stedim Biotech Group and a global leader in biologics contract testing and biosimilar characterisation for the biopharmaceutical industry, today announced the opening of a new facility which doubles Biooutsource’s capacity for future growth. “Our opening of this new, state-of-the-art facility demonstrates our commitment to our growing list of global customers,†commented BioOutsource CEO, Gerry MacKay. “Demand for our services remains high and we are doubling our capacity to make sure we are ready to support the…

July 29, 2015

EMD Millipore Adds Protein Pegylation to Portfolio of Services for Biopharmaceutical Industry through Collaboration with celares GmbH

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EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced a collaboration with celares GmbH to provide pegylation services to customers developing protein-based therapeutics and biosimilars. The new service offering enabled by the collaboration includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale. Pegylation, the attachment of polyethylene glycol to a molecule, can significantly improve the pharmacological and physicochemical properties of peptide and protein…

July 27, 2015

The ViMix Vertical Shaker for Viscous Sample Mixing

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Zinsser Analytic GmbH has developed a multi-position vertical shaker that can mix several samples in parallel using a 15 mm vertical movement at up to 1200 cycles per minute. Traditionally, samples can be mixed in many ways: magnetic stirring, orbital vortexing, horizontal shaking, rocking, overhead stirring etc. But in the main rotational mixing through vortexing is mainly used. However, with a vertical “up and down†motion, substantially higher acceleration can be achieved and hence better sample mixing. A vertical shaker…

July 24, 2015

Monoclonal Antibody Production: Viral Clearance and Host Cell Protein Reduction Using a High Capacity Single-Use Strong Anion Exchange Device

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Strong anion exchange (Q) chromatography is an industry standard for polishing purification steps of mAb production. It is a proven technology which removes viruses, and host cell proteins from process feed streams in flow through mode. NatriFlo HD-Q devices adsorbers feature a hydrogel membrane which combines high dynamic binding capacity and salt tolerance to deliver best-inclass performance. This makes it possible to rapidly process large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q…

July 20, 2015

Monitoring Protein Unfolding and Refolding

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Proteins exist in a highly ordered, folded state. This highly ordered structure of a protein is integral to the efficacy and safety of a protein-based biotherapeutic. Protein unfolding and refolding are an indicator of protein stability. As a protein begins to unfold, the hydrodynamic radii of the protein species change. Denaturation of proteins may range from slight and reversible conformational changes to a drastic loss of solubility, leading to irreversible aggregation. Monitoring the stability of the different protein conformations is…

July 15, 2015

Goodwin Biotechnology Announces the Completion of cGMP Manufacturing of an IgM Monoclonal Antibody and IgM : Ligand Conjugate for Q Therapeutics

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Goodwin Biotechnology, Inc., a biological Contract Development and Manufacturing Organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing Mammalian Cell Culture expression systems and Bioconjugation technologies, has partnered with Q Therapeutics, Inc., a clinical-stage developer of novel cellular therapies for central nervous system (CNS) diseases to provide GMP antibodies for manufacture of clinical trial materials. To do so, Goodwin Biotechnology completed Process Development, Scale Up, and cGMP manufacturing of an IgM antibody and an IgM: Ligand…

July 13, 2015

Changing Column Packing from an Art into a Science

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Chromatography is often the most critical step in biopharmaceutical downstream processing because of its role as the engine for separating impurities from target biologics. The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards. Traditionally column packing has been the responsibility of a few specialist operators and has been regarded almost as an art by most observers. When the…

July 7, 2015

Lonza Announces Additional Long-Term Agreement with Alexion

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Lonza Group Ltd today announced the signing of a new long-term product supply agreement with Alexion. Under the agreement Lonza will construct and launch a new suite dedicated to Alexion manufacturing. Lonza will own and operate the suite as part of its Portsmouth, NH (USA) site. This contract is an expansion of an existing manufacturing agreement. This agreement will supplement existing production of Alexion products at multiple Lonza facilities. The expansion of the existing site in Portsmouth, near Boston, MA…

July 2, 2015

EMD Millipore Expands Provantage® Biodevelopment Services with Addition of Provantage® Clone Generation Service

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EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced expansion of its Provantage® Biodevelopment Services to include a Clone Generation Service. With this addition, the Company now provides a full range of services for optimizing yield, productivity, consistency and efficiency of clinical scale drug products. The new Clone Generation Service includes expression of recombinant proteins such as hormones, growth factors and mono- and bi-specific monoclonal antibodies. Customers can choose from DG44 and CHO-S cell lines,…

July 1, 2015