Friday, December 14, 2018 Daily Archives

Development and Application of a Simple and One-Point Multiparameter Technique: Monitoring Commercial-Scale Chromatography Process Performance

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In commercial-scale biopharmaceutical manufacturing, downstream chromatography steps are still a bottleneck and contribute to significant operational costs (1, 2). Some of those costs are inherent (e.g., resins, large buffer quantities, and cleaning) whereas others are avoidable (e.g., product loss due to rejected lots or deviations that result in production downtime). Maintaining efficient and robust chromatography process performance is therefore critical for minimizing operating costs. To do so, we introduce a simple and one-point multiparameter technique (SOP-MPT) for monitoring chromatographic process…

December 14, 2018

Speeding Characterization of Biologics: Replace Traditional Assay Technologies with Label-Free Quantification and Kinetics

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FortéBio’s Octet instruments are an ideal replacement for ELISA, HPLC, and SPR techniques in quantification of antibodies and recombinant proteins and in testing product potency for lot release. Bio-Layer Interferometry (BLI) technology monitors biomolecular interactions in real time to determine affinity, kinetics, and concentration. The plate-based, microfluidics-free format offers users several distinct advantages over other technologies. BLI-based systems can achieve higher throughput, with the flexibility to measure two to 96 samples simultaneously. Lower maintenance requirements and increased ease-of-use further shorten…

December 14, 2018

Elucidation: Changes in VA Healthcare Pose New Implications for Drug Companies

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Veterans of the US military still struggle to access healthcare despite the 2014 congressional passing of the Veteran’s Choice Program (VCP), a US$10 billion-dollar “fix†that allows qualifying veterans to see community physicians who have contracted with the Department of Veterans Affairs (VA) to provide care. Veterans who enrolled in VCP to avoid long wait times at department medical facilities still have faced month-long delays before seeing a doctor, according to a 2018 GAO report. Investigators have found that the…

December 14, 2018

FDA paves way for insulin biosimilars, but will they be interchangeable?

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Sanofi will see its short-acting follow-on insulin Admelog be regulated as a biosimilar from 2020 under US FDA plans to promote competition. But the need for additional studies to show interchangeability could delay any impact, the firm says. The US Food and Drug Administration (FDA) has been actively pursuing efforts to increase adoption of biosimilar products over the past year. In July, the Agency published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire…

December 14, 2018

Ask the Expert November: Expediting Characterization and Maximizing Reliability of Process Validation

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On 24 October 2018, BPI presented a free “Ask the Expert†webinar with Abel Hastings, director of process sciences at Fujifilm Diosynth Biotechologies. He discussed the use of systematic tools to expedite process characterization and maximize reliability of process validation campaigns. Hastings’s Presentation As a project moves from clinical manufacturing toward process validation — and ultimately toward preapproval inspections — project timelines can become hypervisible at all levels of an organization. Missteps can be costly. The commercial viability of a…

December 14, 2018

Ask the Expert November: Improving CHO-Cell Biomanufacturing with a Whole-Genome CRISPR Screening

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On 18 October 2018, BPI presented a free “Ask the Expert†webinar with Jamie Freeman, a bioproduction product manager at Horizon Discovery. His company is developing a whole-genome screen using clustered regularly interspaced short palindromic repeats (CRISPR) for improving the capacity of Chinese hamster ovary (CHO) cells in biomanufacturing. Freeman’s Presentation Freeman described the screening approach that Horizon developed to improve its own CHO cells. It also may be used to improve other such cell lines for biomanufacturing. Founded 11…

December 14, 2018

Ask the Expert November: New High-Performance AEX Resin for Purification of Large Biomolecules

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On 20 September 2018, Jiali Liao (principal scientist in process chromatography R&D at Bio-Rad Laboratories) led a BPI “Ask the Expert†webinar introducing the high-performance, high-capacity Nuvia HP-Q Anion Exchange Resin, which can be used for purifying large biomolecules. Liao’s Presentation Purifying large biomolecules — e.g., plasma proteins, immunoglobulins, viruses, virus-like particles (VLPs), and PEGylated proteins — can be difficult. Their size makes for slow diffusion through the pores of traditional chromatography resins and poor mass-transfer kinetics, which decreases binding…

December 14, 2018

Stilmas buys MarCor to boost global biopharma water biz

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Stilmas Americas has been formed from the acquisition of Canada’s MarCor, bringing its purified water and water for injection (WFI) solutions to North America. The deal sees Stilmas add the high purity division of MarCor to its business. Finanacial details have not been divulged. Stilmas is a subsidiary of the Masco Group, a conglomerate which offers engineering, pure media systems – including WFI stills, purified water systems, pure steam generators – and super skid preparation systems to the biopharma industry,…

December 14, 2018