Pharma Logistics Editorial
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4 Risk Mitigation Strategies For mRNA Production
4/17/2023
Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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New DSCSA Compliance Blueprint Includes FDA & Industry Input
4/12/2023
Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.
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Final Guidance Locks In FDA’s Definitions For Suspect And Illegitimate Drug Product
4/7/2023
With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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Strategic Procurement For Emerging Pharmas & Biotechs
2/27/2023
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.
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Building In Boulder – A Biotech Finds A Manufacturing Base
2/13/2023
If any of you have thoughts of building internal development and manufacturing facilities (to supplement or augment your outsourcing,) this is a discussion for you. It describes how on cell-therapy company made key decisions.
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What Is Contributing To The API Shortage?
2/8/2023
No, you can’t have your cake and eat it, too. In this case, your “cake” is a 6-cents-worth generic pill. We have seen a precarious competitive situation with generic drug manufacturing for several years now; what are the key trends and their impacts on the pharma supply chain? Let's investigate.
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The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
1/19/2023
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
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The Best CDMOs Are Redundant
1/16/2023
The top CDMO-selection criteria for Perry Calias, Chief Operations Officer, Revolo Biotherapeutics, and a veteran outsourcer, is redundancy. Redundancy laced with relationships, that is. Here's how it can work for you.
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Recession? We’re Not Even Over COVID
12/19/2022
Executives say what began with the COVID-19 outbreak, and now the red flags raised over the state of the overall economy, feel like an inseparable supply-chain and outsourcing challenge. The unfortunate amalgam is expected to continue throughout 2023. Part 2 in our series ...