The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Data Analytics For Better ClinRO Quality
Many 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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How Pharmaceutical Manufacturers Can Take Control Of Their Supply Chain
In an increasingly competitive and regulated landscape, the right ERP system is no longer optional—it’s essential to reclaim control and drive growth in pharmaceutical manufacturing.
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Flexible Integrations To Reduce Risks And Increase Efficiencies
Learn 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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Developmental Testing Of IV Solutions
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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Advantages Of Robotic Aseptic Processing
Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.
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Transportation Solutions For Cell And Gene Therapy Supply Chains
Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.
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Considerations When Selecting An Interactive Response Technology Provider
Interactive response technology (IRT) systems ensure clinical trial participants receive the correct treatment, facilitate enhanced logistics tracking, and empower users to obtain real-time data.
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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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Risk Mitigation Planning For Pharmaceutical Tariffs
Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.
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RTSM: Randomization And Cohort Management, IP Inventory Management
Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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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.