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Top Stories
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.
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The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.
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Industry News
Researchers who are younger than 35 years with an advanced degree and working within Europe will be able to apply for the award.
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CPhI releases the bio trends portion of its annual report, which predicts an increase in bioconjucation expertise and biopharma productivity over the next five years.
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Biopharma News
The divestiture of the European generic-drug business of Sanofi—Zentiva—to Advent International has been completed.
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The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.
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Did you know you can streamline your workflows with a faster, more in-depth view of your biologic with Multiple Attribute Methodology (MAM).
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Supplier News
Kangstem Biotech has selected Orgenesis subsidiary, MaSTherCell, as its contract manufacturing partner for the European clinical trial of Furestem-AD.
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A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.
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Regulatory News
As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.
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The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.
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24th Annual Validation Week
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.
 Learn more
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FEATURE TOPICS |
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QUALITY BY DESIGN
Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
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MANUFACTURING
While food, shelter, and clothing are the primal essentials for life, hope—as embodied by modern medicine—has now become part of that human expectation.
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QUALITY SYSTEMS
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
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UPCOMING WEBCASTS
Timely, Accurate Analytical Purity Data Helps to Avoid Late Surprises When Scaling Up.
Automated TEM Analysis Data of Gene Therapy Vectors and VLPs
Thursday, November 1, 2018 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Using High-Throughput Automation to Accelerate Biologic Drug Formulation
Thursday October 25, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Protein A Chromatography: Important Features in Purification to Reduce mAb Aggregation and Increase Recovery
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Bispecific Single-Domain Antibody Fused to Monoclonal Antibody (SMAB): The Natural Form
Wednesday, October 17th, 2018, at 11am EDT|8am PDT|4pm GMT|5pm CEST
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Make Better Decisions, Faster with Highly Reproducible, High-Throughput Glycan Screening
Europe Broadcast: Friday, October 12, 2018 at 3pm BST | 4pm CEST
US Broadcast: Friday, October 12, 2018 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific Broadcast: Monday, October 15, 2018 at 11am CST | 12pm JST | 1pm AEST
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Events
October 9–11, 2018
October 9–11, 2018
October 14–17, 2018
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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