Outsourced Pharma App Notes & Case Studies
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Pluripotent Stem Cell Expansion And Scale-Up
8/5/2020
Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.
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The Value Of A BD Integrated System For Combination Products
7/24/2020
The growing complexity and regulatory rigour of combination products has called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers.
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Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies
12/26/2019
The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”
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A Practical Look At Flow Chemistry
11/17/2020
There has been much discussion about the potential impact of “flow chemistry” on pharmaceutical manufacturing. While the technology does hold promise for the future, it also presents many challenges and choosing the right application will be critical to overcoming them and ensuring a successful implementation.
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Upstream Platform For Continuous Lentiviral Vector Production
12/1/2020
Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.
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Align Your CMC Strategy With Clinical Path Requirements And Timeline
11/18/2020
Manufacturers must understand the challenges associated with creating a CMC strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.
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Securing Bioprocess Film Supply
7/9/2019
Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.
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Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda
4/8/2019
Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.
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Meet The Scientist — Sundeep Sethia, Ph.D.
2/26/2021
When meeting Dr. Sundeep Sethia, one is struck by the sense that they are speaking with someone who is engaged in their work each day, and according to Sundeep, “nothing is more fulfilling.” Sundeep has dedicated his life toward overcoming bioavailability and solubility challenges in the drug development process.
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How Should You Prepare For Foreign FDA Inspections During COVID-19?
2/25/2021
As the COVID-19 pandemic continues, it is important to understand the expectations of regulators about how to facilitate paper-based facility inspections in lieu of those performed on site.