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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The Medicines Of Tomorrow: A Primer On The Gene Editing Landscape
Learn about the distinction between gene therapy and gene editing, as well as the therapeutic potential of CRISPR treatments and the challenges associated with clinical trials and commercialization.
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Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs
Explore how a platform which integrates drug substance, drug product, and clinical testing within a single organization accelerates development and reduces project costs, helping deliver positive outcomes earlier.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing
Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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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.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Applying High Throughput Processes To Optimize AAV Titers
- rAAV Production Using HEK293 Cell Line And Transfection Medium
- Recombinant Protein Purification Optimization With HIC
- Higher Order Structure Of Proteins By Circular Dichroism Spectroscopy
- Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges
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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- 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