Top Stories
Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.
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Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.
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Best Practices for Effective Product Transfer
LIVE WEBCAST: Wednesday, January 20, 2016 at 11:00am EST
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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Industry News
Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.
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EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.
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Supplier News
Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.
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PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.
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Bio/Pharma News
AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.
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Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.
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Regulatory News
The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.
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Changes in China's Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.
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FEATURED TOPICS |
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FACILITIES
All openings and potential breaches for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.
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FORMULATION
Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.
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INGREDIENTS
A strong API market is expected in 2016 despite fewer new drug approvals.
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BIOSIMILARS
Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes for determining biosimilarity.
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WebcastS
On Demand
Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency's Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ
On Demand
In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services
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Events
February 2, 2016–February 4, 2016 | New Orleans, LA
March 14, 2016–March 16, 2016 | San Antonio, TX
May 23, 2016–May 25, 2016 | Berlin, Germany
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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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Pharmaceutical Technology's Drug Development Application Handbook is a compilation of technical articles from the magazine's archives and application notes, technical information, and educational materials from the handbook's sponsors.
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