FEATURED EDITORIAL
New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.
- Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
- Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
- Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview
- Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
- A Spy At Moderna
- Assessing pDNA Purity For Cell & Gene Therapies
- SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
GUEST COLUMNISTS
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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview
This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.
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Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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Assessing pDNA Purity For Cell & Gene Therapies
Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.
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SUS, PAT, And Other Tech Advancing Upstream Bioprocessing
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
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Integrating Quality Processes And Documentation After A Merger
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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NK Cell Therapies: How Artiva Biotherapeutics Leverages Its “Manufacturing First” Approach
We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.
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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.
PHARMA OUTSOURCING WHITE PAPERS
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Validated HPLC-UV Method For Quantification Of Paxalisib
Examine research into the development and validation of a HPLC method for the quantitation of paxalisib in mouse plasma and its potential use for routine therapeutic drug monitoring.
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Match Your Development And Manufacturing Path To Your IND Milestones
The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.
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β-Glucan As A Process-Related Impurity In Biopharmaceuticals
In this white paper, we dig deeper into the sources of β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.
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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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The Role Of The Technical Transfer Executive Sponsor
Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.
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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.
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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