Search results for " supply chain" in Articles / App Notes
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Unlike other biological drug products such as therapeutic proteins, monoclonal antibodies, or vaccines, drugs based on living cells are by nature uniquely vulnerable to supply chain complications and …
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Managing Risk in Raw Material Sourcing
In a business environment in which final drug product manufacturers with even the most advanced programs can typically only see two levels deep into their supply chains (3), this represents progress. …
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
“[In the US,] we have been supporting the [pharmaceutical] industry for the final milestone, the Drug Supply Chain Security Act (DSCSA) deadline of November 27, 2023,” says Sturtevant, and advances ha…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Another important consideration in selecting single-use consumables is ensuring the supply chain is robust. Switching out any element of a validated process requires significant additional work. There…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
When mitigating the risk of drug shortages, it is important to take a global view of the overall supply chain, in addition to establishing comprehensive risk-management programs at each manufacturing …
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Raw Material Variability
Raw material supply chains are complex and multi-tiered. Risk management tools are expected and widely used for impact assessments and to focus on the most important issues.
The industry is now …
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A Look Ahead at BioPharma Manufacturing and Regulation
BioPharm: How will these new requirements affect the supply chain and drug shortages?
FDA: The new drug safety authorities FDASIA grants FDA reflect a more comprehensive and transparent view of…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Properly optimizing cleaning and sterilization cycles where stainless-steel equipment is used, validating procedures, having a well-trained staff, and having a robust yet simplified supply chain are k…
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The Challenge of Disruptive Technologies in Bioprocessing
Customers are demanding overall efficient, cost-effective solutions, faster, just-in-time service and delivery, supply chain logistics, full [good manufacturing practice] GMP documentation, high consi…
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Managing Biomanufacturing Capacity Expectations
When the date for market launch is set, these companies will often look for additional CMOs to back up their supply chain.”
Excess capacity
As mentioned, it is common to overestimate or undere…