“Process intensification” is one of those big umbrella terms that unfairly implies a concept that comes with an instruction manual. It doesn’t. It isn’t prescriptive. It doesn’t have to start in a specific place, and it really never ends.
- 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
- FDA Publishes Final Guidance On Reporting Listed Drug Amounts
EDITOR'S DESK
-
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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Digitizing CMC Knowledge Management
Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.
BIOPROCESSING WHITE PAPERS
-
Next Gen Plasmid Technology: Improve Performance, Safety, Manufacturing
Nanoplasmids have paved the way for facilitating a wide range of cell and gene therapeutic applications. Gain an overview of a novel technology and specific benefits.
-
Improve Your Molecular Cloning Process With Synthetic Biology Automation5/25/2023
Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.
-
Aseptic Sampling Devices In A Bioburden Reduction Strategy8/31/2022
This paper delves deeper into aseptic sampling devices to explain how they offer exceptional performance in the effort to control contamination.
-
A Mammalian Suspension Technology For Scalable rAAV Production3/13/2024
Explore a HEK293 derived animal component-free suspension cell line as the foundation of an up to 2000-liters scalable and robust platform process that increases the speed of AAV manufacturing.
-
Understanding Potency In Gene Therapy Development2/28/2024
Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.
-
Strategies For Ensuring Biomanufacturing Resilience For Biologics6/29/2023
Long-term collaboration in resilient biomanufacturing capacity and supply chains ensures the reliable delivery of health technologies. Investigate biomanufacturing resilience strategies for biologics.
BIOPROCESSING APP NOTES & CASE STUDIES
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 -- 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
- 04.23.24 -- Women In Biotech With Bill & Melinda Gates MRI's Piper Trelstad, Ph.D.