FEATURED EDITORIAL
With explosive demand, expanding indications, and rapid innovation, the GLP-1 revolution is reshaping dealmaking. Here's a practical guide for companies negotiating M&A in this arena.
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- The Transition To E-Labeling Is More Than Uploading PDFs
- Are You Still Evaluating CMOs When You Really Need A CDMO?
- Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?
- Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs
- Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry
- Program Manager Alignment And Integration: Best Practices When Working With A CDMO
GUEST COLUMNISTS
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Are You Still Evaluating CMOs When You Really Need A CDMO?
Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.
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Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?
Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.
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Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs
Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.
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Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry
Among other benefits, the approach can help compare CAR constructs, evaluate the effects of manufacturing processes, and monitor changes in protein interactions.
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Program Manager Alignment And Integration: Best Practices When Working With A CDMO
This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.
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New Guide Aims To Build Robust Framework For Digital Validation Tools
The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.
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Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms
The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.
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How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides
A class of enzymes previously believed to be specific and intolerant of change might actually have broad applicability.
PHARMA OUTSOURCING WHITE PAPERS
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A Powerful Non-Destructive Tool For Tablet Characterization
Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.
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Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
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Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
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Designing, Selecting, And Developing Bioconjugates For Clinical Success
Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.
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Placing Drug Strategies On A Solid Foundation For Success
Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 11.04.25 -- Transforming Oral Therapeutics With Advanced TPD Technologies
- 11.04.25 -- Will It Not Die? The BIOSECURE Act Back With Iterations
- 11.03.25 -- Simplify The Journey Of Advancing Your Therapies To Patients
- 11.03.25 -- STREAM Edition: Second Sourcing Is Natural ... Your Current CDMO Should Understand
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ON-DEMAND WEBINARS
- How To Select The Right Bioanalysis CRO For Your Program
- The Future Of Gene Therapy Production: Enriching Full Capsids, Reducing Costs
- Developing Your Risk-Based Approach To Single-Use System Integrity
- Smarter CMC Strategies To Accelerate Next-Gen Biologics To The Clinic
- Your Journey To GMP With Emphasis On Linker Payload Development