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TOP STORIES
Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.
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Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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Industry News
The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.
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The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.
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Sartorius Smart Consumables
Cell expansion of the future: MYCAP® CCX combines integral tubing and a specially-designed gas exchange cartridge in the same cap closure. Grow cells in the incubator and passage between flasks without ever opening a flask or going into a biosafety cabinet.
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Biopharma News
Aimmune plans to introduce the antibody as an adjunctive treatment with its Characterized Oral Desensitized ImmunoTherapy programs to research treatment outcomes in patients with food allergies.
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The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.
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Supplier News
The new facility includes six classified environment rooms with space to expand.
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The knockout CHO K1 cell line will be used to support biotherapeutic R&D across a range of therapeutic indications.
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Regulatory News
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.
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The FDA Commissioner plans to address drug prices, the drug approval process, and supply chain issues during his time as commissioner of FDA.
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FEATURED TOPICS |
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MANUFACTURING
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
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FORMULATION
Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.
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ANALYTICAL METHODS
Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
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QUALITY/REGULATIONS
Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.
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New Products and Services
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With more than 30 years of experience in biologics services, Catalent’s Paragon Gene Therapy provides industry-leading process development, scale-up, and cGMP manufacturing services for leading innovators of transformative therapies.
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Eurofins BioPharma Product Testing offers complete CMC Testing Services for the bio/pharmaceutical industry, including all starting materials, process intermediates, drug substances, drug product, packaging, and manufacturing support through our broad technical expertise in biochemistry, molecular and cell biology, virology, chemistry, and microbiology.
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TAKE THE SURVEY
Expert input is needed for the bio-industry's most in-depth, global benchmarking and analysis study, which examines current global and regional trends affecting the bioindustry. Participants who complete the survey receive a free aggregated summary of the study results, a free whitepaper on the Top 15 Trends in Biopharmaceutical Manufacturing, and the opportunity to share insight about trends in biomanufacturing. For each completed survey, BioPlan Associates will contribute $10 (up to $3000) to a global health charity.
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February 18–20, 2020
February 23–26, 2020
March 10–11, 2020
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eBook
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In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.
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