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Top Stories
The agency has approved Mylan's Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen's Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.
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The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie's Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche's Herceptin.
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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
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
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The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.
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Supplier News
FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.
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Bio/Pharma News
Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.
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GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
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When it comes to patient safety, should close enough ever be good enough? Celsis® rapid microbial detection takes the guesswork out of determining your product's sterility by providing a definitive yes or no result for the most critical of decisions. Through reagent-catalyzed amplified ATP-bioluminescence detection, even the lowest levels of microbial ATP can be rapidly intensified to detectable levels.
Take the guesswork out at criver.com/celsis |
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Regulatory News
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
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FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
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Eurofins Lancaster Laboratories PSS Insourcing Solutions (PSS) is a global, award-winning managed service provider that employs and manages full-time employees to perform a defined scope of work at your facility. Our project-based insourcing solutions are specifically designed to give you laboratory services support with flexible timeframes and no worries about co-employment and other regulatory concerns, at lower costs than fixed headcounts.
Learn more about PSS |
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ASEPTIC/STERILE
Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
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DRUG DEVELOPMENT
Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.
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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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PROCESS VALIDATION
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
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MANUFACTURING
Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
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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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Events
June 11–15, 2018
June 14–15, 2018
June 20–21, 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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