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.
- 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
- 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
- AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
- Digitizing CMC Knowledge Management
- Managing Supply Chain Risks Using Relational Risk Analysis
EDITOR'S DESK
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Doubling Down On Biopharma’s Growing Skills Drought
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.
In the U.K., a professor at the University of Birmingham is using virtual reality (VR) to help address the growing biomanufacturing skills shortage — using virtual reality (VR).
GUEST COLUMNISTS
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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.
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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.
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Managing Supply Chain Risks Using Relational Risk Analysis
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
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When Does GMP Matter In Non-GMP Settings?
Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.
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What Really Happens When A Cell Therapy Supply Chain Fails?
A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.
BIOPROCESSING 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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Cybersecurity And Product Design Of Automated Systems9/30/2022
Learn about the importance of cybersecurity for automated equipment, it's weaknesses and risks, and how to mitigate for them by sensible practice and good system design.
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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.
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Using SerumSub™ QualAssure™ To Assess Liquid Transfer Performance11/13/2023
In this study, SerumSub™ QualAssure™, a serum-like reference solution with liquid handling properties that are analogous to several commonly used sera, is compared to various commercially available mammalian sera.
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The Heroes Of Vaccine Development: Lipid Nanoparticles2/8/2024
Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.
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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.
BIOPROCESSING APP NOTES & CASE STUDIES
- Applying A Platform Approach To Bispecific Antibody Development
- Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies
- Comparison Of The Bioprocess Controllers For CHO Cultivations
- Peptide Mapping Study On Human Erythropoietin
- Reliability Assessments And Benchmarking In Life Sciences
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
- How To Get Started With Organ-On-A-Chip Technology
- ChipChat With Emulate: Answering Your Organ-Chip Questions Live
- Assessing Reproductive Health With A Human Vagina-On-A-Chip
- A Pharmaceutical Perspective On Generating And Utilizing Multiomic Data
- Efficacy Evaluation Of AAV-Delivered Liver-Specific Promoters
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 04.19.24 -- Developing & Implementing A Continuous Bioprocess Control Strategy
- 04.18.24 -- Bringing Therapies To Patients With Speed And Confidence
- 04.18.24 -- Process Mapping For More Effective Knowledge Management
- 04.17.24 -- Optimizing Drug Delivery Systems For Complex Biologics
- 04.17.24 -- Leverage Innovative Assays And Monitoring To Improve mAb Production