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Top Stories
Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.
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The acquisition allows Lonza to further develop technology for scalable autologous cell-therapy manufacturing.
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Industry News
Fujifilm Diosynth Biotechnologies and the Centre for Process Innovation (CPI) are collaborating to complete the technology transfer of the expression and purification of model monoclonal antibodies (mAbs) as part of AMECRYS, a research project funded by the European Commission.
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A project funded by BioProNET will investigate optimization for bioprocessing of gene therapy vectors using hydrodynamic fluid flow fields.
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Biopharma News
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
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The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie's blockbuster Humira (adalimumab).
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Supplier News
Thermo Fisher Scientific has entered into a collaboration with Symphogen to deliver validated, platform workflows for simplified characterization and quality monitoring of complex therapeutic proteins.
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IVT's 6th Annual Laboratory Week
IVT's 6th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Hear from FDA and choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding analytical procedures and methods validation, stability testing and lab data integrity.
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Regulatory News
A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA's new plan to advance plant and animal biotechnology innovation.
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The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
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DOWNSTREAM PROCESSING
This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
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REGULATORY
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
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Events
November 4–7, 2018
November 12–13, 2018
December 10–12, 2018
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eBook
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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