Author Archives: BPI Contributor

Optimizing Cell Culture Productivity: New Findings on the Impact of Recombinant Protein Supplements

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This webcast features: Harris Grevelis, Product Manager for Upstream Technologies at Repligen Cell culture supplements are essential for long-term growth and productivity of cell lines in serum-free media formulations. Both insulin and LONG®R3 IGF-I, a more potent supplement that directly targets and activates the IGF-I receptor, are employed by the biopharmaceutical industry today to support the growth of recombinant cell lines. This webinar will show how these two supplements, used separately and in combination, impact viable cell density and IgG…

October 29, 2015

EMD Millipore Introduces Millipore Express® PHF Hydrophilic Sterilizing-Grade Filters

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EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today introduced Millipore Express® PHF (process protection, high-flux) hydrophilic filters for fast, efficient and economical buffer filtration. The single layer, fast-flowing 0.2 µm PES membrane filters provide sterilizing-grade performance and are ideal for buffers, pH adjusters and other process additives and intermediate fluids as well as cleaning fluids. The single-use, gamma ready filters are available in a fully scalable range of sizes from 25 mm to 30 inch…

October 27, 2015

EMD Millipore to Provide Provantage® End-to-End Solution for Development and Manufacture of Biosimilars under Strategic Alliance with Turgut Ilaç

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EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced the Company has entered into a strategic alliance with Turgut Ilaç, a leading biosimilars company based in Turkey and will provide their Provantage® End-to-End services for development and manufacturing of biologics. EMD Millipore’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. The turnkey package includes process development, cGMP manufacturing, facility design,…

October 26, 2015

Lonza Authors Recent Publication on Availability of cGMP-Manufactured Human Induced Pluripotent Stem Cells for Pre-Clinical and Clinical Applications

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Lonza, a global leader in the field of cell therapy development and manufacturing, announced today the publication of an article about the recent completion of the production of clinical-grade induced Pluripotent Stem Cells (iPSCs). The success was reported in a peer-reviewed article titled “cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications†in the scientific journal Stem Cell Reports. The article can be found in Lonza’s Knowledge Center: www.lonza.com/ipscarticle The discovery of iPSCs and the availability…

October 15, 2015

Sartorius Stedim Biotech Launches Flexsafe® 3D Pre-Designed Solutions for Storage and Shipping Applications

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Today, single-use bags are increasingly used in all process steps of biopharmaceutical manufacturing. Their robustness, performance and quality consistency are crucial for ensuring the safety and economy of bioprocesses. This is why Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, developed a new polyethylene film and the Flexsafe® family of bags that provide outstanding quality and significantly facilitate implementation of next-generation single-use factories. The complete control of the resins, film, bags and their final assembly, as…

October 15, 2015

Characterization of Subvisible Particles in Vaccine Development

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Vaccine manufacturers want meaningful information that can be linked to process knowledge to increase product quality and eliminate patient safety issues. New requirements from the United States Pharmacopeial Convention (USP) and the U.S. Food and Drug Administration (FDA) put pressure for root cause analysis to understand impact on changes during process and product development. The new demands involve not only size and distribution but deeper characterization that involves morphology and composition studies as part of particle characterization. Nanoparticles like virus,…

October 14, 2015

Voisin Consulting Life Sciences Acquires B&H Consulting Services

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Voisin Consulting Life Sciences (VCLS), the global healthcare product development consultancy and B&H Consulting Services, Inc. (B&H), an experienced regulatory firm helping pharma and biotech companies facilitate interactions with FDA and navigate the regulatory process, today announced that they are joining forces. The transaction forms one of the largest independent consulting groups delivering high-end regulatory services to support the interactions with the U.S. Food and Drug Administration, the European Medicines Agency, and other global health authorities. VCLS and B&H now…

October 14, 2015

Lonza and Benitec Enter Agreement to Develop Scalable AAV Manufacturing Process for ddRNAi Therapeutics

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Lonza Houston, Inc., a global leader in biological, cell and viral gene therapy manufacturing, and Benitec Biopharma, a clinical stage biotechnology company commercializing a patented gene-silencing technology, DNA-directed RNA interference (ddRNAi), today announced that they have entered into a Manufacturing Services Agreement to develop a scalable manufacturing process for Benitec’s ddRNAi-based, Adeno-Associated Virus (AAV)-delivered products intended for therapeutic use in humans. This relationship will leverage Lonza’s expertise to facilitate the development of a cost-effective, scalable and robust suspension culture-based manufacturing…

October 7, 2015

Taking Medium and Feed Development Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up

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This webcast features: Serena Fries Smith, Process Science Manager, Thermo Fisher Scientific In the early 2000s when many processes were struggling to achieve 1 g/L, maximizing titers was the industry’s biggest challenge and was essential to having favorable cost of goods and an economically viable product. Over the last 10-15 years, the industry has made significant advances in media and feeds. Due to these advancements, today a standard fed-batch process can typically achieve 3 g/L and some processes are achieving…

October 1, 2015

Vetter to Invest 300 Million Euro in Manufacturing Sites

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Vetter has announced that it will invest approximately 300 million euros to expand and upgrade its manufacturing facilities over an estimated five-year period. As a leading contract development and manufacturing organization, Vetter is continuously developing its manufacturing sites and techniques to prepare them for future needs and requirements. The upgrades are being driven by a changing healthcare market that is affected by issues such as ever-more complex molecules, smaller batch sizes, and increasing regulatory requirements. The first of the facility…

September 30, 2015