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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing
Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.
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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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Using Next Generation Sequencing Methods For Virus Vector Identity Testing
Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.
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Remote Access And Monitoring Of Bioprocess Unit Operations
Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.
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Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.
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Nasal Vaccine Development, Manufacturing, And Device Selection
When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
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.
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