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Top Stories
Novartis will acquire assets associated with Takeda Pharmaceuticals' Xiidra (lifitegrast ophthalmic solution) 5%, an eye-care drug.
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The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.
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Industry News
AbCellera, Niaid Vaccine Research Center, and Ichor Medical Systems have formed a partnership to develop an end-to-end platform capable of developing field-ready, nucleic acid-based countermeasures against a pandemic strain of influenza.
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It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States.
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Biopharma News
Lonza will provide development and manufacturing services to two of Alector's neurodegeneration drug candidates.
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Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic's C1 gene expression system.
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Supplier News
Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.
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Vibalogics has increased its single-use bioreactor and purification capacity with a new manufacturing for its specialist oncolytic virus and viral vector manufacturing services as a result of a growth in demand.
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Regulatory News
EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.
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The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
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FEATURED TOPICS |
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DRUG DEVELOPMENT
Sterile filtration is often required for biologics but presents degradation and compatibility challenges
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UPSTREAM PROCESSING
Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.
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QUALITY SYSTEMS
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals' most significant critical quality attributes and enable real-time release.
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May 15–16, 2019
June 3–6, 2019
June 18–20, 2019
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eBook
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Experts share insight and advice for conducting CMC due diligence with contract development organizations, using multiple attributes methods to monitor quality attributes, and strategies for using specialized services for biopharmaceutical development applications.
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