As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
- 7 Bioprocess Intensification Strategies
- Improving Governance And Compliance With Knowledge Management
- 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
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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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.
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GMP Plant Uniform Lockers And Procedures: Best Practices
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
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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.
BIOPROCESSING WHITE PAPERS
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Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.
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Generation Of Stable CHO Cell Lines For Protein Production3/22/2024
By following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.
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The Business Case For Pharmaceutical Continuous Manufacturing6/2/2023
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market2/15/2023
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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Critical Cleaning For 3D Printing In The Life Sciences8/17/2022
Here, we focus on the critical cleaning of hard surfaces utilized in 3D printing processes across industries, such as extruded plastics, photosensitive substrates, metals, and metal alloys.
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Selecting Optimal Chromatography Resins To Support mAb Purification10/2/2023
Discover key considerations when selecting resin options for mAb purification, including alternatives to the conventional affinity capture step.
BIOPROCESSING APP NOTES & CASE STUDIES
- How A Biotechnology Company Chose To Improve Their Data Management
- Implementation Of Raman Spectroscopy For In-Line Monitoring
- Electron Activated Dissociation Workflow For Biotherapeutics Characterization
- Rapid Separation Of Circular RNA Using An mRNA Analysis Kit
- Parallel Processing Of Charge Heterogeneity Analysis Of Protein Therapeutics
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.
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NEWSLETTER ARCHIVE
- 04.26.24 -- Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield
- 04.25.24 -- Digitizing CMC Knowledge Management
- 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.