FEATURED EDITORIAL
Jesse Mendelsohn, a "pharmaceutical regulatory compliance and government pricing” guru, who manages a life sciences group of over 100 consultants, says currently the biggest disruptor to our industry in 2004 is the Inflation Reduction Act (IRA), the 2023 legislation passed by Congress and signed into law by President Biden.
- BIO Expels WuXi, Agrees With U.S. Government
- Doubling Down On Biopharma’s Growing Skills Drought
- A Structured Approach To Regulatory Information Management Vendor Selection
- Super Generics: Market Trends In Europe
- What Investors Teach Us About CDMO Selection
- Getting To Know MAM, The New Quality Control Strategy On the Block
- What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
GUEST COLUMNISTS
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Super Generics: Market Trends In Europe
Super generics combine advanced formulations and delivery methods, and improved bioavailability, compared to traditional generics. This article shares market research trends in the market in Europe.
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Getting To Know MAM, The New Quality Control Strategy On the Block
When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.
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What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.
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Navigating China's Biologics Approval And Accelerated Pathways
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Drugging The Undruggable: Strategies And Future Directions
Progress with PROTACs and molecular glues hasn’t come without challenges, particularly in identifying the right chemistry starting point for drug development — a process known as hit discovery. This article looks at the role of CRISPR, screening assays, and more.
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8 Key Takeaways Of The Proposed FDA Modernization Act 3.0
On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.
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Shocking! Biotech Facilities Don't Maintain Themselves
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.
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Green Gains In Biopharma Without Closing Facilities?
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
PHARMA OUTSOURCING WHITE PAPERS
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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Accelerating The Development Of Orphan Drugs For Rare Diseases
Explore four principal CMC challenges for the developers of orphan drugs and the potential emerging solutions.
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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Partnering With Clinicians To Improve Pediatric Formulation Development
Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
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Sterile Filtration And Quality Risk Management
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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The Promise Of PCM: Getting To Maturity
PCM offers a number of advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Streamlining The Integrity Testing Process – From Test To Report
- Overcoming Inventory Challenges For A Complex, Global Study
- Automating And Optimizing The Cell Harvesting Process
- Empty/Full Capsid Ratio Of AAV By Sedimentation Velocity – Analytical Ultracentrifugation
- Process Control And Performance Of A Depth Filtration System
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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ON-DEMAND WEBINARS
- Identify And Quantify AAV Fill States Using Analytical Ultracentrifugation
- De-Risking Development With Analytical Characterization Capabilities
- Identify And Mitigate Absorption Risks With PBPK Modeling
- Idea To Clinic: Accelerate Your Manufacturing Timeline To FIH Studies
- Breaking Bad Manufacturing Habits: Attaining Sustainable API Production