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2 months ago | 
pharmaceuticalonline.com | Stephen Aiken |Allison Jackson |Barbara Schulz |Yadnyesh Patel
Top Considerations For Risk-Based Cleaning Validation Process DesignLearn how implementing a systematic approach to cleaning validation can significantly enhance compliance and improve your audit readiness. How To Adapt Efficiently To A New Era Of Supply Chain ManufacturingCOVID-19 reshaped the pharmaceutical landscape, and its impact on the supply chain is undeniable. As the industry adapts to a new reality, executives are prioritizing reliable, forward-thinking partnerships.
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Jan 16, 2025 | 
biosimilardevelopment.com | ajaz Hussain |Yadnyesh Patel |Vaibhav Patel
With a third wave of biologics patents expiring, the race is on to seize the booming opportunities in the fast-evolving biosimilars field. What’s driving the patent scramble? What hurdles in manufacturing, regulation, and market access must be cleared for biosimilars to thrive? And how are global industry leaders carving out strategies to dominate the market? Don’t miss Bioprocess Online Live happening February 4th.
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Jan 15, 2025 | 
outsourcedpharma.com | Louis Garguilo |Yadnyesh Patel |Vaibhav Patel |Yves Massicotte
Transitioning Your Product from Phase 1 to Phase 2 Clinical StudiesTransitioning oral solid dosage (OSD) forms from Phase 1 to Phase 2 clinical studies demands effective strategies and solutions to overcome formulation and development challenges. This whitepaper explores practical techniques to refine formulations, manage Phase 1 outcomes, and optimize timelines.
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Oct 22, 2024 | 
laboratorynetwork.com | Yadnyesh Patel
By Yadnyesh Patel, microbiology subject matter expertSterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.
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Oct 18, 2024 | 
outsourcedpharma.com | Louis Garguilo |Yadnyesh Patel |Kimberly Shepard
Components of the WuXi global organization are for sale. It’s a forced divestiture. WuXi AppTec is marketing some of its U.S. and European operations. The ill-advised BIOSECURE Act targeting several China-based biopharma companies is having its intended effects, even before the legislation is fully passed by the U.S. government. Where do you stand?
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Oct 15, 2024 | 
pharmaceuticalonline.com | Yadnyesh Patel
By Yadnyesh Patel, microbiology subject matter expert
In my first article of this series on sterility assurance, I discussed fundamentals of sterility assurance, including terminologies and key components such as aseptic processing, terminal sterilization, and post-aseptic processing terminal sterilization. In this article, I continue the series by discussing nine key contributing factors for maintaining sterility assurance.
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Oct 8, 2024 | 
pharmaceuticalonline.com | Yadnyesh Patel
By Yadnyesh Patel, microbiology subject matter expert
Sterility assurance is a critical aspect of the production of pharmaceuticals, biopharmaceuticals, medical devices, and other sterile products, encompassing all measures taken to ensure the absence of viable microorganisms that could compromise patient safety.
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Sep 14, 2024 | 
bioprocessonline.com | Jon C. Strauss |Tim Sandle |Yadnyesh Patel |Jessica Carmen
AUGUST'S BEST FEATURED EDITORIAL9 Common Tech Transfer Pitfalls To AvoidMany issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each. Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. RecommendationsICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.
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Sep 10, 2024 | 
laboratorynetwork.com | Yadnyesh Patel |Tim Sandle
This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more. The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.
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Aug 15, 2024 | 
biosimilardevelopment.com | Yi Yang |Yadnyesh Patel |Samantha N. Atkinson
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| August 15, 2024
Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret WeaponAs the U.S. government works to pass the BIOSECURE Act, which aims to the protect the IP of U.S. pharma companies, the EU is simultaneously seeking to increase innovation across the European biomanufacturing industry.
