Author Archives: BPI Contributor

Enabling Custom Solutions for Downstream Processing for Future Therapies: AAV Case Study

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This webcast features: Orjana Terova, Purification Product Manager, Thermo Fisher Scientific There is a need in the industry for a standard purification strategy for the manufacture of novel molecules including viral vectors and oligomeric therapies. Working with customers, Thermo Fisher Scientific has developed innovative purification resins through the POROS™ custom resin program and CaptureSelect™ ligand technology. This combination of ligand and resin development has allowed for development of platform purification processes that increase productivity and improve product yield for gene therapies.…

December 12, 2016

The Standardization of Single-use Components for Bioprocessing

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As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology. This paper discusses standardization in…

December 12, 2016

Challenges of Scale Up and Development of Insect Cell Culture and BEVS

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This webcast features: Sharyn Farnsworth, Associate Principal Scientist, FUJIFILM Diosynth Biotechnologies A strategy for scale up and implementation of Insect Cell Culture (ICC) should be assessed at the earliest stages of process development as there are a different set of challenges in the culture of ICC and BEVS versus a CHO culture and a limited number of vendors experienced enough to guide you through the adventure of manufacturing ICC. Each system has a unique problem set ranging from which cell…

December 8, 2016

Lonza to Divest Peptides Business and Operations in Braine-l’Alleud, Belgium, to PolyPeptide

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Lonza and the PolyPeptide Group jointly announced today that PolyPeptide Laboratories Holding (PPL) has entered into a definitive agreement with Lonza Sales AG and Lonza AG (both 100% affiliates of Lonza Group AG) to acquire the peptides business and operations of Lonza in Braine-l’Alleud, Belgium. Lonza’s Braine facility, with approximately 280 employees, is the center for peptide chemical development and manufacturing within Lonza. The agreement is expected to close in the next weeks, subject to customary closing conditions. The acquisition…

December 7, 2016

Finesse® Solutions Launches Second Generation G3Lite+™ SmartController for Single-Use Bioreactor Systems

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Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life sciences process applications, announced the launch of its new G3Lite+ SmartController for upstream cell culture and fermentation. The G3Lite+ extends the capabilities of Finesse’s G3Lite product for all major brands of single-use bioreactors (50L to 2,000L operating volume) and single-use fermenters (30L to 300L operating volume). The G3Lite+ is now available for Mobius® CellReady, Thermo Scientificâ„¢ HyPerformaâ„¢ TK SUB, GE Xcellerex XDR, and Pall PadReactor® single-use vessels. The…

December 6, 2016

MilliporeSigma to Provide Provantage® End-to-End Services to Acticor Biotech SAS

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MilliporeSigma today announced that it will provide its Provantage® End-to-End services to Acticor Biotech SAS for accelerated development and manufacturing of Acticor’s antibody fragment used for the primary treatment of ischemic stroke. MilliporeSigma’s Provantage® End-to-End solution is a comprehensive suite of products and services enabling biopharmaceutical companies to accelerate progress of molecules into the clinic and toward commercialization. “Our Provantage® End-to-End solution will provide Acticor with a fast and flexible approach to development and clinical-scale manufacturing,” said Udit Batra, Member of…

December 5, 2016

The Total Cost of Buffer Preparation and Handling

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This webcast features: Eric Langer, Managing Partner, BioPlan Associates, Inc. Most bioprocessing facilities consider in-house preparation of buffers and bulk liquids to be a core bioprocessing task. However, some companies are now outsourcing liquid manufacturing, by purchasing ready-to-use materials from vendors or hiring CMOs to prepare these. Buffers and bioprocessing liquids are one area of upstream production operations that is seeing an increase in outsourced operations. Bulk liquids can be a bottleneck in downstream processing, with buffer volumes often required…

December 5, 2016

MilliporeSigma Launches Parteck MXP Excipient for Increased Solubility

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MilliporeSigma, a leading science and technology company, today introduced Parteck® MXP, a polyvinyl alcohol-based excipient that enhances solubility of a wide range of active pharmaceutical ingredients (APIs) with poor bioavailability. Parteck® MXP excipient maintains stability at temperatures above 200 degrees Celsius, making it well-suited for hot melt extrusion (HME), a process used by drug manufacturers to enhance the solubility and bioavailability of APIs. The new excipient can achieve drug loads of 30% or more, while other excipients may be limited…

December 2, 2016

MilliporeSigma Expands Distribution Agreement with Roche in Canada

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MilliporeSigma today announced an expansion of its distribution alliance with Roche to include the polymerase chain reaction (PCR) and quantitative real-time PCR (qPCR) enzyme products of Kapa Biosystems, a company acquired by Roche in 2015. The addition of the Kapa portfolio strengthens MilliporeSigma’s existing distribution relationship with Roche by providing one of the most complementary suites of high-performance tools for PCR and qPCR in the industry today. “The alliance extension with Roche will offer our customers greater access to novel products…

December 1, 2016

Natrix Separations Announces Collaboration Agreements with Merck and Sanofi for the Development of Membrane-Based Protein A Purification Platform

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Natrix Separations Inc. today announced development agreements with Merck, known as MSD outside the United States and Canada, and Sanofi to advance Natrix’s new membrane-based Protein A platform for antibody purification. The Natrix Protein A platform is expected to pave the way for a new generation of more flexible, highly-productive single-use based biologics production facilities for both batch and continuous processes. The platform is predicted to increase purification productivity by a factor of up to 10x, while reducing both cost…

November 30, 2016