Top Stories
In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen's patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.
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Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.
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Pressure is mounting to reduce costs and spending on prescription drugs.
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Industry News
The agency provides quality, development, manufacturing, and labeling recommendations.
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FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.
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EXPERT INTERVIEW
Nicolle Courtemanche, senior applications engineer at SPX Flow, sat down with Pharmaceutical Technology to discuss scale up of biologic products.
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Supplier News
Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.
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Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.
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Bio/Pharma News
Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.
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Emergent is seeking approval for the manufacture of BioThrax at the company's large-scale manufacturing facility.
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For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.
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Regulatory News
The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
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ASEPTIC/STERILE
Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.
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Bio/Pharma in China
New Initiatives, New Opportunities
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Webcasts
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When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
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An understanding of the variable process parameters that have a significant impact on the final pharmaceutical product is necessary to successfully manage a hot-melt extrusion process when using twin-screw extrusion. Experts will discuss residence time, mechanical-energy consumption, and other critical parameters, as well as their effects on a scientific approach to process scale-up. Sponsored by Thermo Fisher Scientific
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Events
August 10-11, 2016
August 17-18, 2016
September 12-14, 2016
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.
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