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Top Stories
AbbVie will grant Mylan license to launch a biosimilar to AbbVie's Humira.
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FDA is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
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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
Report predicts PAT, NIRS, continuous bioprocessing, and a 'technological arms race' could improve biopharma manufacturing efficiencies.
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Annual awards program recognizes innovation in bio/pharmaceutical drug development and
manufacturing.
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Supplier News
Catalent Biologics will adopt Berkeley Lights' Beacon optofluidic platform for its cell-line development workflow.
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Moderna's new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.
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Bio/Pharma News
Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.
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Next Generation Raman imaging
Renishaw has decades of experience developing flexible Raman systems that give reliable results, even for the most challenging measurements. Interested in learn more about our Raman systems? Come visit us at the M&M Show in Baltimore on August 5th – August 9th at Booth #408 and the ACS National Meeting & Expo in Boston on August 19th – August 23rd at Booth #2322.
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Regulatory News
Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom's departure.
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Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
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Cleaning Validation:
As the industry's leading hands-on cleaning validation training, IVT's Cleaning Validation conference goes beyond best practices and solution oriented approaches; from bring your own challenge workshops and brainstorming think-tank discussions to solutions showcases and faculty "office hours" attendees are guaranteed to walk away with key actionable items for tackling the top challenges faced throughout critical cleaning process and validation lifecycles specific to their own environment.
www.cbinet.com/cleaning |
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PACKAGING
Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.
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MANUFACTURING
The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.
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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems. www.cbinet.com/dataintegrity |
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EXCIPIENTS
With the right excipients, formulators can control when, where, and how an API is released.
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QUALITY SYSTEMS
Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
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UPCOMING WEBCAST
How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, and Risk
Tuesday, August 7, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Building a Faster, More Flexible Biologic Development Process for Targeted Therapies
Tuesday, July 31, 2018 at 10am EDT | 3pm BST | 4pm CEST
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How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
Wednesday, July 25, 2018 at 11 am EDT | 8 am PDT | 4 pm BST | 5 pm CEST
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A Short Journey to Bio/Pharmaceutical UHPLC Method Transfer Success
Tuesday, July 24, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
August 6–10, 2018
August 13–14, 2018
August 15–16, 2018
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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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