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TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.
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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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SubscribeSubscribers can enjoy each full issue of BioPharm International in print, or via BioPharm apps.
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Industry News
A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.
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The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020.
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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.
Learn More »  |
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Biopharma News
Boehringer Ingelheim will use the partnership to reveal novel insights into the complexities of various inflammatory diseases, which opens the potential for a clearer understanding of potential candidate biomarkers.
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The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.
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Supplier News
Remote, machine health monitoring services reduce the need for on-site visits.
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The collaboration will add diversity to Alexion’s commercial portfolio and will give the company access to Portola’s commercialized medicine, Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo).
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Regulatory News
A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.
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Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.
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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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QUALITY/REGULATIONS
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
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WEBCASTS
Practical Method Development Strategies for the Analysis of Monoclonal Antibodies by Reversed-Phase HPLC
Thursday, May 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Vaccines Illuminated: Biophysical Characterization, PAT, and Quality Control via Light-Scattering Techniques
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Are You Seeing the Whole Picture? Backgrounded Membrane Imaging (BMI) as a Multi-Use Analytical Tool for Developability Assessment through Late Stage Formulation
Tuesday, May 12, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Accurate Weighing of Reference Standards in a QC Laboratory
Thursday, May 28, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Viral Vector Process Development:
Applying CE and MS Techniques for In-Process Testing
Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
CPhI North America has been rescheduled for September 2020.
CPhI Japan has been rescheduled for September 2020.
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
Interphex 2020 has been rescheduled for April 2021.
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eBook
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The Pharmacopoeia Compliance Series features a description of ways biopharma companies can participate in monograph development, a case study of a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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