FEATURED EDITORIAL
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
- It's Years Later And We Still Disagree: Free WuXi From The BIOSECURE Act
- Data Confirms Europe's CDMOs Succeed Despite U.S. Gyrations
- FDA's Guidance On Cell And Gene CMC Codifies Flexibility
- Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?
- AI And Data Pull CDMOs Into Pharma's Commercial Strategy
- Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
- Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
GUEST COLUMNISTS
-
Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?
Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.
-
Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.
-
A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.
-
Managing Organic Impurities And Nitrosamines In APIs
How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.
-
AI Has Arrived In Biotech CMC Amid Patchwork Governance
AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.
-
Avoiding Common Pitfalls In CDMO–Sponsor Relationships Through Integrated Execution Models
Let's delve into the key pitfalls to avoid when working with a CDMO and the integrated execution model that solves or mitigates these pitfalls before they occur.
-
The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process
Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.
PHARMA OUTSOURCING WHITE PAPERS
-
Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies
Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.
-
Advancing Drug Development With Optimized LC-MS/MS Bioanalysis
Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.
-
Transformative Innovation: Advancing Drug Development Using In Silico Modeling
Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.
-
Next-Generation CRISPR Approaches
By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.
-
Bispecific Antibodies Unleashed
Explore how leveraging expert CDMO partnerships can streamline the development process and enhance the efficacy of your bispecific antibody therapies.
-
Speeding Up Safety: An Evaluation Of Mycoplasma Technology
Rapid mycoplasma testing enhances cell and gene therapy safety by reducing turnaround time, minimizing sample needs, and delivering sensitive, reliable contamination detection across diverse matrices.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Development Of A Non-Standard Protein Therapeutic
- Diversifying Single-Use Technology With Cytiva XDR Bioreactors
- Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process
- Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool
- Bend Successfully Rescues Powder-Filled Capsule Program
REPORTING
PRODUCTS & SERVICES
ON-DEMAND WEBINARS
- Solving Formulation Challenges Across Modalities
- Viral Safety Testing In Biologics: Detecting What Current Methods Miss
- Cracking Complexity: Learnings From 70+ Bispecific Antibody Programs
- Faster Clones, Simpler Process: What's Changing In CHO Expression?
- How Solid-State Science Solves Your Toughest API Challenges