The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- 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
ON-DEMAND WEBINARS
This webinar will offer best practices for UAT for sponsor organizations with the aim of changing the conversations and expectations around the UAT process.
This webinar presents the ultimate guide to scenario planning through modern technology as a way to inform clinical supply decisions.
Learn about strategies that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.
This panel webinar discusses the importance of clinical supply agility and how to mitigate supply chain risk that comes along with clinical supply decisions.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1276580570-cryopreservation]( "Key Considerations For Labeling Your Cell Or Gene Therapy")
Key Considerations For Labeling Your Cell Or Gene TherapyAs sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.
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![GettyImages-836663414 medical team meeting]( "Sponsor Overcomes Hold And Steers Products Through Development")
Sponsor Overcomes Hold And Steers Products Through DevelopmentUncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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![Risk Management-GettyImages-665231256]( "Flexible Integrations To Reduce Risks And Increase Efficiencies")
Flexible Integrations To Reduce Risks And Increase EfficienciesLearn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.
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![GettyImages-1265108955 data]( "Level Up Your Supply Chain Initiatives")
Level Up Your Supply Chain InitiativesShipping and storing advanced therapeutics are complex processes, but advancements in accountability, wearables, and technology capture real-time factors critical to safety and protocol.
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![GettyImages-2170642314-year 2025]( "What Does 2025 Hold For Pharma?")
What Does 2025 Hold For Pharma?Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.
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![An Insider’s Guide To Interactive Response Technology (IRT) For Clinical Trials]( "Modern Architecture's Impact On UX In Next-Gen Interactive Response Tech")
Modern Architecture's Impact On UX In Next-Gen Interactive Response TechExplore how Interactive Response Technologies (IRTs) built around microservices models can provide faster initial builds, more rapid change management, and improved built-in test automation.
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![GettyImages-1425605790 Life Sciences Training. Scientists Using A Computer In A Lab]( "Treating Deficiencies In Employee Training And Mentorship")
Treating Deficiencies In Employee Training And MentorshipInvesting in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.
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![Computer analytics, planning-GettyImages-1473508663]( "Data Analytics For Better ClinRO Quality")
Data Analytics For Better ClinRO QualityMany trials fail not because of ineffective treatments, but due to challenges in detecting treatment signals. Explore how advanced data analytics can improve ClinRO quality.
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![GettyImages-1156884561-fill-finish]( "Key Considerations For Selecting Flexible Fillers")
Key Considerations For Selecting Flexible FillersFlexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Top Clinical Research Themes And Trends")
Top Clinical Research Themes And TrendsWe analyzed web traffic, content downloads, social media engagement, webinar attendance, and other metrics to determine the themes that caught your attention and aligned with broader industry trends.
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.
