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What is process characterization?

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
What is process characterization?
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News and Press Releases

Oxford Genetics licenses SnapFast™ expression vectors to Twist Bioscience

November 16, 2017, Oxford, England and San Francisco, US. – Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, announced today a new licensing agreement with Twist Bioscience Corporation, a company enabling customers to succeed through its offering of rapid, high-quality synthetic DNA. Oxford Genetics will supply Twist Bioscience with its SnapFast™ technology platform to provide a broad range of application-specific expression vectors which Twist Bioscience will use to clone synthesized DNA for its diverse customer base.
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White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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Cell Therapy Manufacturing & Gene Therapy Congress

6-7 December 2017, RAI, Amsterdam

Bringing together 300+ leaders and key influencers from pharma and biotech companies on 6 - 7 December 2017 in Amsterdam, Cell Therapy Manufacturing & Gene Therapy Congress will provide you with the latest advice for driving manufacturing and commercialisation through direct access to transforming innovative research to prosperous cell & gene manufacturing.
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