The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.
- What Global Survey Says About Scant Patient Access To CAR-T Therapy
- Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
- Peeling Back The Layers Of Radiolabeled Peptide Production
- Multispecific Trial Supply Stability Hinges On CDMO Agility
- Bracing For The Impact Of The Federal Workforce Reduction
- A Road Map For Transitioning From A Research-Focused To Commercialization Mindset
- Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations
- Formulation Is Key For Y-mAbs' Self-Assembling Antibody
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Outlook 2025: Key Trends & Insights
Dive into the key trends and challenges shaping the year ahead, from geopolitical uncertainties to cutting-edge innovation in AI, oncology, and weight-loss therapies.
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Investigational Medicinal Products: Labeling Changes And Their Implications
Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.
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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.
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Enhancing Clinical Supply Chain With Signant SmartSignals Supplies
A global pharma leader improved supply chain efficiency and compliance by digitalizing processes with Signant's SmartSignals Supplies, achieving better visibility, traceability, and reduced errors.
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Inside A Gene Therapy Facility, Commercialization & Industrialization Project
An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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Building A Global Cell And Gene Supply Chain Serving Personalized Medicine
Clinical distribution paths can be fragile for a multitude of reasons, making it critical that pharmaceutical sponsors and their partners orchestrate supply chain logistics even before site initiation.
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IRT? RTSM? What's The Difference?
What are the components of Randomization and Trial Supply Management (RTSM) and the critical role of RTSM and Interactive Response Technology (IRT) in clinical trials?
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Logistics In Cell Therapy: Reducing Workflow Risk
Explore key steps that should be taken when executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention.
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Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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Insights from Catalent's Clinical Supply Experts |
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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.