Top Stories
The acquisition of AurKa Pharma will help strength Eli Lilly’s oncology pipeline.
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Right-to-Try bill has been sent to White House for President Trump’s signature after passage by Congress.
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Industry News
ExcipientFest has been acquired by IPEC and rebranded as Excipient World.
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The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
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Supplier News
Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.
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Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.
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Bio/Pharma News
The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
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Regulatory News
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
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Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
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As the landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data, it is critical for the biopharmaceutical industry to adhere to new regulatory expectations.
Analytical Procedures & Methods Validation Europe provides a comprehensive understanding of regulatory trends and requirements, "hands-on" training for executing procedures that survive the lifecycle and solutions to challenges within the laboratory.
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ANALYTICS
This article looks at a simple structured approach to assigning variance contributions and to assuring that the analytical procedure is fit for purpose.
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OUTSOURCING
Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.
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IVT's Stability Testing Europe allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Don't miss the chance to participate in hands-on training for small molecules, biologics and medical devices to harmonize global systems and enhance stability programmes.
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SUPPLY CHAIN
Shipping biopharmaceuticals in single-use containers requires a thorough understanding of the distribution cycle and potential transportation risks.
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QUALITY ASSURANCE/QUALITY CONTROL
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
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UPCOMING WEBCASTS
A Rational Approach to Excipient Selection
Wednesday, June 20, 2018 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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E&L and Beyond: Qualifying Plastic Materials for Contaminants and Failure
North America: Tuesday, June 19, 2018 at 11am EDT | 10am CDT | 8am PDT
Europe: Tuesday, June 26, 2018 at 9am BST | 10am CEST
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Continuous Processing in Biomanufacturing Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
Thursday, June 14, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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How to Package Highly Complex Biologics
Wednesday, May 30, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The Pharma Supply Chain Revolution
Thursday, May 24, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
June 4–7, 2018
June 6–7, 2018
June 14–15, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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