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.
- 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
- What Time Is Best To Bring My CDMO On Board?
- Single Use In Biopharma: Beyond Savings & Sustainability
- Unpacking The Importance Of Lipid Nanoparticle Production Platforms
- Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
EDITOR'S DESK
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Eying Up The Era Of Topical Biologics
Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis (NK) is breaking new ground in the development of topically administered biologic therapies.
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.
The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.
Check out the results of DeciBio's Antibody-Drug Conjugates 2024 Industry Survey, which predict another bullish year for the growing modality.
The U.S. imported $6.95 billion worth of pharmaceuticals from China in 2022. That was 8x the amount we imported in 2021. A proposed Act of Congress puts that supply, and U.S. biotech itself, in serious peril.
GUEST COLUMNISTS
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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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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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Unpacking The Importance Of Lipid Nanoparticle Production Platforms
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
BIOPROCESSING WHITE PAPERS
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A Framework For Controlling Variability And Optimizing Assay Performance
By employing a process optimization approach to assay development, you can improve overall assay performance.
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Fc-fusion Cell Line Development: Expression And Analytical Strategies5/15/2023
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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Development And Optimization Of Suspension-Adapted 293T Cell Line3/21/2024
Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.
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Modeling The Economics Of Vaccine Manufacturing5/26/2023
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Response To FDA Black Box Warning3/1/2024
The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.
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COGs Process Economics For Autologous Cell Therapy8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.
BIOPROCESSING APP NOTES & CASE STUDIES
- Quantify Secreted T Cell Activation Markers
- The Application Of The Species-Specific Liver-Chip In Predicting Hepatoxicity
- Culturing Of Sf 9 Insect Cells With The BEVS, And SEAP Production
- Sterilizing Grade Filter Performance With Biologic Drugs
- A Perspective On Various Use Cases Of Osmolality In Quality Control
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Culturing And Characterizing Organoids And Cancer Spheroids
- How To Get Started With Organ-On-A-Chip Technology
- Optimizing Perfusion Parameters For Intensified Production Of CAR-T Cells
- Innovative Preservation Solutions For Cell Therapy
- De-Risking The Aseptic Drug-Filling Process And Optimizing Production
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.24.24 -- Biopharma Equipment Sourcing Strategies To Reduce Costs And Risks
- 04.24.24 -- Improve Your Process Development To Accommodate Diverse mAbs
- 04.23.24 -- Genetic Stability Simplified. One Method, Multiple Answers.
- 04.23.24 -- Business Of Biotech Newsletter
- 04.23.24 -- Novel Approaches In Chromatography Process Development