Article
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By Jan Vertommen, Iwan Bertholjotti, and Dr. Bernhard Stump,
Lonza
Improving your ADC’s chance of clinical success requires an understanding of what potential obstacles lie ahead and what capabilities and expertise are necessary to overcome them.
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Article
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By Brian Ball,
Nikka Densok USA, Inc.
In pharmaceutical and food packaging, there are multiple methods widely used to test if these container-closure systems pose any risk of leakage from pinholes, cracks, or defective seals.
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Article
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By Dr. Felix Heise and Dr. Thomas Kosian,
Syntegon Pharma Technology Inc.
Read how experience and analyses can counteract the risks associated with the effects of hydrogen peroxide (H2O2) when it is used for decontamination.
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Article
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By Christy Eatmon,
Thermo Fisher Scientific
It is important to adopt strategies that create simple but stable formulations for your sterile injectable, thereby establishing a solid foundation for the entire life cycle of your product.
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Article
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By Tyler Harris,
PTI Packaging and Inspection Systems
What do CDMOs need to know about container closure integrity testing and the solutions available that will help protect products and drive quality?
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Article
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By Lisa Cherry, Ph.D.,
Pfizer CentreOne
Changes in raw materials are inevitable over a drug's lifespan, but even small modifications can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.
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Article
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By Eleonora Bellissimi, Hue Rose Pham, and Paul Magreta,
CHIRON Recombinant Proteins
Learn how a CDMO helps biopharma organizations predict and mediate technical transfer risks before they become costly, time-consuming problems.
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Article
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By Keith Bowen,
Apprentice
Like it or not, your next FDA audit is coming. With the help of these guidelines, you’ll have no issues passing your next inspection.
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White Paper
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By Josh Hoops,
CAI
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
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White Paper
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By Suzanne Kuiper, Ph.D.,
Lighthouse Instruments
Nondestructive headspace analysis can be used to directly quantify the gas concentration inside a sealed parenteral package. It can be applied to a range of product configurations and formulations.
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White Paper
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By Garrett Krushefski,
Mesa Laboratories
We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.
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Q&A
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By Yves Massicotte,
Ropack Pharma Solutions
Learn how outsourcing this key aspect of bringing product to market can benefit your organization and overall supply chain optimization.
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Article
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Thermo Fisher Scientific
Though there are many factors that can challenge a drug candidate’s progress, one of the most critical is managing the sourcing, supply, and manufacturing of cell culture media.
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Article
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Cytiva
We describe a straightforward way to achieve a high-performing fed-batch process for a knockout cell line. This workflow improved titers 500% compared with CHO cell culture in basal medium.
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Case Study
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Silverson Machines, Inc.
A manufacturer was producing medical paste using a 5 to 10 gallon drum using a simple propeller mixer. The FMX25 helped them to produce larger batches in a much shorter time and improve the quality of the product, which was consistent from batch to batch.
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Webinar
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Altis Biosystems
See how a simpler approach utilizing a monolayer of primary human epithelial cells can more accurately predict GI toxicity.
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