Top Stories
FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.
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NICE announces plans to back biosimilar alternatives to Remicade.
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Industry News
CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.
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Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.
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Supplier News
Vetter announces completion of multi-functional building for development service and IT functions.
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Siemens and ADENTS develop joint solution for drug serialization challenges.
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Technology Transfer from a CDMO Perspective
Joe Cobb, CPIP, director of pharmaceutical development at Metrics Contract Services, recently shared industry challenges from the contract manufacturing side of the industry on tech transfer, which continues to be one of the main challenges of the pharmaceutical industry when it comes to outsourcing.
 Learn more and view Cobb's presentation at metricsinc.com. |
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Bio/Pharma News
Amgen announces FDA will review the company’s BLA for ABP 501.
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The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.
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Cost Effective Solutions to Develop and Manufacture Product
INTERPHEX is a premier pharma, bio and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the full product development life cycle. Join us in New York, April 26-29, 2016. Register for your complimentary Technical Education and Exhibit Hall Pass Today at  www.INTERPHEX.com/Register. Discover what’s NEW at #INTERPHEX. |
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Join the conversation surrounding the newest trends in biopharmaceutical approaches and bioprocessing technologies and manufacturing sciences being applied for development and commercialization. The
 2016 PDA Annual Meeting continues to be the foremost event providing a platform for information sharing and networking, equipping participants and their companies with the best information to overcome the rapidly evolving challenges of yours.
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WebcastS
On Demand
Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by Dow
On Demand
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by Tosoh Bioscience LLC
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Thursday, February 11, 2016 at 8 am PST / 10 am CST / 11 am EST
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.  Register now
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on pharmtech tv
Tablet Coating
Resolving Drug Shortages
Pharma & Biopharma Outsourcing Association
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Events
February 21-25, 2016
March 14-16, 2016
April 26-28, 2016
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Best Practices for Effective Product Transfer
ON-DEMAND
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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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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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
more ebooks |
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