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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Key Stages In mRNA-Based Therapeutic Development
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
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Fc-fusion Cell Line Development: Expression And Analytical Strategies
Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support through the predicted growth in Fc-fusion clinical applications.
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Process Development Considerations For RNA-LNP Therapeutics
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
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Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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GMP-Validated Adventitious Virus Testing By Next Generation Sequencing
Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 03.18.24 -- BIO Agrees With U.S. Government: WuXi Is An Enemy Of The State
- BIO Agrees With U.S. Government: WuXi Is An Enemy Of The State
- 03.15.24 -- BIO Agrees With U.S. Government: WuXi Is An Enemy Of The State
- 03.14.24 -- Stable Cell Lines: Stepping Stones For Continuous Viral Vector Manufacturing
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
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- 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