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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Digital Transformation: A Critical Component For CDMOs
Learn how embracing the digital transformation is key for managing complexity of speed, service, quality, regulatory compliance, and capacity as well as the obstacles facing CDMOs looking to innovate.
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CRISPR RNPs And The Future Of Cell And Gene Therapy
Explore the potential of ribonucleoprotein (RNP) to deliver CRISPR materials more accurately, efficiently, and effectively, as well as the manufacturing challenges which require further attention.
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Overcoming Challenges In AAV And LV Viral Vector Manufacturing
Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production.
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Optimization Of Hydrogen Peroxide Decontamination
Understanding critical influencing factors of hydrogen peroxide bio-decontamination is key for reliable process parameters.
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Taking Charge Of Your Stability Program
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
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Cell Line Development: The Linchpin In Successful Biotherapeutic Development
Review key factors for building a reliable CLD strategy and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.
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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