Top Stories
Industry experts identify the future focus of the biopharma industry in a new survey.
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FDA published a flurry of guidance documents in late 2016.
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Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?
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PODCAST
Keith Hutchison, senior vice president of Research and Development, Capsugel, speaks with Pharmaceutical Technology about the applications of this technology in formulation development.
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Industry News
An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.
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Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?
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Supplier News
With this new line, Bischof + Klein will double its extrusion capacities for its CleanFlex clean room films.
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The company made a new strain of the influenza virus available for use as a challenge agent in clinical trials.
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Get the best guidance for choosing, maintaining, supporting and installing a monitoring system. Learn how to choose the number and placement of sensors along with other details of a regulated monitoring system. Get the WHO Technical Supplement #6 for Temperature and Humidity Monitoring Systems for Fixed Storage Areas from Rotronic.
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Bio/Pharma News
The company announced that it has terminated an agreement made with UMN Pharma for the co-development of influenza vaccine programs in Japan.
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The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company's leading multiple sclerosis treatment.
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Regulatory News
FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.
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The agency plans on publishing more than 100 new or revised guidance documents in 2017.
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PARTICIPATE! Need your input for BioPlan's 14th Annual Global Biopharmaceutical Manufacturing Study -
BioPlan will donate $10 (up to $2,000) on your behalf to global health charities - Be the first to receive a FREE Aggregated Summary of this year's results AND receive our UPDATED 15 Top Trends in Biopharmaceutical Manufacturing White Paper.
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PEER-REVIEWED RESEARCH
The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
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Your Connection to Global Pharmaceutical Manufacturing Suppliers.
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QUALITY
A four-stage process to successfully make the switch from paper to electronic batch records is presented.
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MANUFACTURING
The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Events
February 1–2, 2017
February 27–March 2, 2017
March 5–9, 2017
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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