Production Featured Articles
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How A CDMO Achieves Finished Product Lyophilization With Limited And Expensive API
6/27/2022
Agile, cost-effective lyophilization services can accelerate the development of complex drug candidates that present stability challenges, but lyophilization can be challenging, expensive, and time-consuming.
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What CDMO's Should Know About Digitization
6/24/2022
Explore how embracing digitization in manufacturing can help CMOs and CDMOs improve the efficiency of their operation and attract company partnerships.
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FDA Updates Guidance For Investigating OOS Test Results for Pharma Production
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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Tips For Successfully Scaling Your cGMP Manufacturing
6/23/2022
What are the specific obstacles to expanding manufacturing capacity? Cell therapy industry leaders share what to look for in a solutions provider and recommendations for navigating your road ahead.
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Real-Time Visibility In Pharmaceutical Manufacturing: Needs & Solutions
6/21/2022
We take a deep dive into real-time visibility and consider the top needs faced by three major players in pharma manufacturing: quality assurance, supervisors, and operators.
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Simplify Bioreactor Scale Up And Scale Down
6/20/2022
We give an overview on the theory of scaling, present workflows and strategies and discuss which data are needed for successful scaling, and present case studies that use a web-based scaling tool.
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A New Mindset For Combination Product Development
6/15/2022
As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.
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Accelerating Novel Therapies To The Market
6/15/2022
The formulations for novel therapeutics 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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mRNA Manufacturing: Overcoming CMC Development Challenges
6/15/2022
A lack of standardization as well as cost-effective techniques for manufacturing and analytics for product characterization create challenges when it comes to establishing CMC principles for mRNA-based products.
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Computational Modeling Of Injection-Related Tissue Responses In Drug Delivery
6/15/2022
Optimizing delivery along with the formulation is the key for successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force and needle length.