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Essential Insights Into Pharmaceutical Product Release: Part 1
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Article | By Rebecca Waterbury, BatchWize and Kimberly Snyder, Exemplar Compliance, MasterControl, Inc.
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Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical process essential for FDA approval and patient safety.
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By Louis Garguilo, chief editor, Outsourced Pharma
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Ali Pashazadeh is "a deep thinker" that our chief editor visits with annually. Recently, he asked Pashazadeh to help us contemplate the evolving policies of the new U.S. presidential administration and the tariff turbulence, as they relate to outsourcing in biotech.
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INDUSTRY INSIGHTS CONTINUED
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Accelerating Novel Therapies To The Market
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Article | By Asmita Khanolkar, Cambridge Pharma, SMC Ltd.
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Formulations require flexibility to support adaptive sterile manufacturing and an integrated approach for a path from development, to small batch manufacturing, to commercialization.
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Capacity Update April 2025: Fill/Finish
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Bora Pharmaceuticals
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Tara Lorenz, Sr. Director of Commercial Operations, speaks on our latest investments and expanded fill/finish capabilities and capacity for small molecules, biologics, and other sterile injectable products.
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Our Biotech Success — Levicept
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Lonza
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Simon Westbrook formed Levicept to develop an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway, and being a true virtual company, he needed a CDMO.
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Commercial/Clinical cGMP Quality Control Analysis
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Lifecore Biomedical
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We implement a system-wide QbD approach to different phases of a clinical or drug product, including raw materials, in-process, batch release, and stability / shelf-life evaluation.
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OUTSOURCED PHARMA CAPACITY UPDATE
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.
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Connect With Outsourced Pharma: |
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