This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
- What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
- What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
- New Group Wants 'Phase-Appropriate' Thinking To Retire
- Inside Arbor Biotech's In Vivo Gene Therapy Approach
- What Sponsors Must Know About Digital Systems And AI Compliance
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Blinded Randomization And Trial Supply Management Gets Support
Uncover how this global specialty pharmaceutical company was able to ensure the confidentiality of its blinded study data while receiving flexible and scalable unblinded support.
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Prepping For Commercialization Through Supply Chain Logistics
While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
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Providing Drug Supply Support In Complex Environments Through IRT
Learn how applying predictive data analytics can enable the creation of an ideal supply strategy capable of reducing the need for extra shipments, manual oversight, and supply waste.
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5 Common Clinical Supply Chain Speedbumps
Clinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.
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Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours
The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.
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Optimized Laboratory Kitting Is Key To Successful Clinical Trials
Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.
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Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
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Prefillable Syringe Plungers: A Solution For Low Temperature Storage
Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.
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Cryobag Container Development For Cell & Gene Therapies
ISR Reports addresses the logistical challenges faced by developers of cell and gene therapies regarding cold chain and cryopreservation.
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Transforming The Pharma Supply Chain
Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.