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Top Stories
Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.
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The companies will partner in research for HIV and hepatitis B immunotherapies, and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead.
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Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.
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Industry News
A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.
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Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.
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Supplier News
Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.
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Bio/Pharma News
The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.
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Alexion Pharmaceuticals and Complement Pharma will partner to develop a preclinical C6 complement inhibitor to treat neurodegenerative disorders.
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At the 2018 PDA/FDA Joint Regulatory Conference, Sept. 24-26 in Washington, DC, industry experts and U.S. FDA regulators will explore the circumstances that impact the quality, safety, and availability of drugs. Gain new perspectives and best practices on the evolving regulatory landscape, supply chain risks, quality culture, and challenges in manufacturing.
Register by Jul. 16 and save up to 400! |
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Regulatory News
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
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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to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing.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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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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MANUFACTURING
From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.
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REGULATORY/GMP COMPLIANCE
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
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UPCOMING WEBCASTS
Engineering and Manufacture of Second Generation ADCs: Tools and Techniques
Wednesday, June 27, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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A Rational Approach to Excipient Selection
Wednesday, June 20, 2018 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
Register now
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
Register now
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
Register now
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Events
June 11–15, 2018
June 14–15, 2018
June 20–21, 2018
more events |
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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