FEATURED ARTICLES
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Women In Bio Profile - Lessons Learned From 10 Years Performing Tech TransfersKelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.
I spoke with Kral about what her experience has taught her about the tech transfer process and her thoughts on single use versus disposable.
- Innovations In UV Oxidation Direct Conductivity TOC Measurement To Improve Accuracy And Precision
- Analytical QbD at Teva: Knowledge Is Power Only When You Share It
- The Falsified Medicines Directive – What Does It Really Mean?
- FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
WHITE PAPERS & CASE STUDIES
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Serialization And The Drug Quality & Security Act: A Top-Down Synergistic Approach
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA).
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The Hidden Value Of Instrument ManufacturersFor those of you who work with any analytical/lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the work flow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process, you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly. By Tara S. Hundley
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Don’t Get Blindsided By New USP Quality StandardsThe U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
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Points To Consider When Developing A TMF (Trial Master File) StrategyMany organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
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3 Tips For Safe, Secure Healthcare ShippingAll businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
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Using Collaborative Review And Authoring Technology Increases Productivity And Drives Value Across The CompanyConatus Pharmaceuticals Inc. is headquartered in San Diego, California and is a privately-held biotechnology company focused on the development of human therapeutics to treat liver disease and cancer. Currently, the company’s primary activity is based on the clinical trials for the treatment of Hepatitis C Virus.
PRODUCTS & SERVICES
EMC® Documentum® Research And Development
Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you’ve outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.
EZ BioPac™: Powder Transfer Process
Advanced Powder Transfer for Media and Buffer preparation and Solids additions.
LIFE SCIENCE WEBINARS
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Common Misconceptions in Freeze-Drying: Part Two
This is the second of two presentations addressing some of the most common misconceptions in freeze-drying (lyophilization) relating to formulations, process cycles, equipment and scale-up.
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Overcoming Analytical Method Development Challenges: Analysis Of Nonclinical Dose Formulations From hERG Studies
This webinar is about overcoming analytical method development challenges with analysis of nonclinical dose formulations from hERG studies.
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Delivering Biologics With A Difference
In this webinar you will learn about delivering intravenous-dosed biologics in an aseptically-filled intravenous bag and increase your understanding of the business drivers and potential value added with this strategy.
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Digital Signatures: Enabling Compliant Collaboration and Streamlined Corporate GovernanceIn this webinar, we’ll focus on the middle office where life sciences organizations can achieve tangible operational improvements and cost savings.