FEATURED EDITORIAL
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
- Improving Governance And Compliance With Knowledge Management
- China’s Rising Role On The Global Stage In The Oncology Market
- Nothing To See Here! Just Big Pharma Investments In China
- GMP Plant Uniform Lockers And Procedures: Best Practices
- A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
- Developing A Process Performance Qualification Master Plan For Gene Therapies
- CDMOs Pelted By Slings And Arrows
GUEST COLUMNISTS
-
Improving Governance And Compliance With Knowledge Management
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
-
China’s Rising Role On The Global Stage In The Oncology Market
The oncology pharma market has largely been dominated by European and U.S. companies. With the ongoing expansion of the Chinese biopharma sector, innovative oncology drugs will emerge from China and compete on the international market.
-
GMP Plant Uniform Lockers And Procedures: Best Practices
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
-
A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
-
Developing A Process Performance Qualification Master Plan For Gene Therapies
This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
-
The EU’s Ban On TiO2 In Food May Impact Pharma. Here’s What You Should Know.
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
-
What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
-
Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
PHARMA OUTSOURCING WHITE PAPERS
-
Can Yeast Be The Future Of Efficient Subunit Vaccine Manufacturing?
To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.
-
Intro To USP <1062> - What It Is And Why You Should Use It
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.
-
Switching From Vials To PFS And Intravenous To Subcutaneous Formulations
Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.
-
Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® Technology
The objective of this study was to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Kytopen’s Flowfect® technology.
-
Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
-
Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Streamlining The Integrity Testing Process – From Test To Report
- Protein L Affinity Resin Is Ready To Move To Manufacturing
- Tangential Flow Filtration System Coupling To Enhance Solution Offerings
- Chromatography Solutions For AAV Full And Empty Capsid Separation
- Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma
NEWSLETTER ARCHIVE
CONTENT COLLECTIONS
They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out. In this latest e-book, Chief Editor, Louis Garguilo sits down with Francis Dumont just after he retired from Pfizer for an in-depth conversation on drug development and manufacturing outsourcing.
More Content CollectionsPRODUCTS & SERVICES
ON-DEMAND WEBINARS
- Risk Control | Bulk Filling Application
- The Synergistic Role Of Drug Safety In Clinical Trial Operations
- De-Risking The Aseptic Drug-Filling Process And Optimizing Production
- Outsourcing High Potent Oral Solid Dose Late-Stage Development: CDMO Insights
- Process Development Optimization For GMP CAR-T Manufacturing