Pharmacopoeia Compliance
Series
Pharma companies must comply with the pharmacopoeia requirements for each country in which they plan to distribute drugs. Often, stakeholders do not have a sufficient understanding of these requirements. In the first article in a series, learn the legal and regulatory basis for pharmacopoeia compliance and the impact of pharmacopoeias throughout a drug’s lifecycle.
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What is necessary for compendial compliance? Bio/pharma companies face internal and external challenges when developing and maintaining effective compliance programs. This article, a second in a series of articles, reviews an end-to-end compendial framework to help drug companies understand why compliance with pharmacopoeia standards is challenging.
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Introducing ABITEC’s new line INJECTA™ parenteral grade lipid excipients
Our excipients enable improved solubilization of injectable active pharmaceutical ingredients (APIs). INJECTA lipid excipients undergo secondary sterile filtration and aseptic processing in state-of-the-art facilities to ensure products are of the highest quality. The entire INJECTA product line is tested for pyrogens, microbial contaminants, elemental impurities, and particulate matter by validated testing protocols.
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New Technologies
West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.
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During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity component needs.
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Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.
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The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.
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BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.
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The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.
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Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.
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A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.
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Contract Service News
Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.
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Catalent has named Mike Grippo as the new senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer.
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Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.
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New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more.
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Events
December 4-5, 2019
December 4-6, 2019
December 9–11, 2019
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eBook
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The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.
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