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
ON-DEMAND WEBINARS
Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient and hybrid services utilizing a global GMP depot network.
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
This webinar provides strategies for clinical supply planners to make immediate improvements in their strategy as well as discuss the need for a holistic end-to-end approach to supply planning.
Choosing the right clinical packaging and supply chain partner to support APAC studies can vary significantly based upon which countries are involved and the types of services required.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![trends-for-2025-GettyImages-2161094939]( "Outlook 2025: Key Trends & Insights")
Outlook 2025: Key Trends & InsightsDive 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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![Medical-Research-laborratory-GettyImages-1354172439]( "Investigational Medicinal Products: Labeling Changes And Their Implications")
Investigational Medicinal Products: Labeling Changes And Their ImplicationsLearn 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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![GettyImages-1333159166-cold-chain-shipping-logistics-transportation]( "Transforming The Pharma Supply Chain")
Transforming The Pharma Supply ChainStart 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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![Supply Chain Management GettyImages-1304746031]( "Enhancing Clinical Supply Chain With Signant SmartSignals Supplies")
Enhancing Clinical Supply Chain With Signant SmartSignals SuppliesA 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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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Inside A Gene Therapy Facility, Commercialization & Industrialization Project")
Inside A Gene Therapy Facility, Commercialization & Industrialization ProjectAn 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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![GettyImages-184945838-cold-chain-cryopreservation]( "Building A Global Cell And Gene Supply Chain Serving Personalized Medicine")
Building A Global Cell And Gene Supply Chain Serving Personalized MedicineClinical 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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![Doctor Clinical Trial]( "IRT? RTSM? What's The Difference?")
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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![GettyImages-1221576332 cell therapy]( "Logistics In Cell Therapy: Reducing Workflow Risk")
Logistics In Cell Therapy: Reducing Workflow RiskExplore 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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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage")
Overcoming The Challenge Of Maintaining Sterility At Low Temperature StorageLearn 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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![GettyImages-1288118586 cell development]( "Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials")
Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical TrialsLearn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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.
