As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
- What Time Is Best To Bring My CDMO On Board?
- Single Use In Biopharma: Beyond Savings & Sustainability
- FDA Publishes Final Guidance On Reporting Listed Drug Amounts
- 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
- Managing Supply Chain Risks Using Relational Risk Analysis
- Designing Highly Agile Bio/Pharma Manufacturing Facilities
- Who The Heck Designed This Biopharm Plant?
GUEST COLUMNISTS
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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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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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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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Designing Highly Agile Bio/Pharma Manufacturing Facilities
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
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Who The Heck Designed This Biopharm Plant?
The Bozenhardts have seen some absurd, expensive facility design errors in their work. They talk about some of the worst ones here so you can avoid the same mistakes.
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How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing
Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.
BIOSIMILAR WHITE PAPERS
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Frontiers In Digital Bioprocessing: Modular Plant Automation And Cloud
As the biopharmaceutical industry is embracing digital transformation and thus evolves in its digital maturity, future-ready concepts will play a leading role in the shift toward bioprocessing 4.0.
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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Controlling Trace Impurities In Chemically Defined Media4/10/2023
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.
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A Risk-Based Approach To Injectable Combination Product Development3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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Establishing Analytical Methods For mRNA-Based Therapies6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
BIOSIMILAR APP NOTES & CASE STUDIES
- Get Full Control Of Your T Cell Isolation
- Scalability And Performance Of Single-Use Bioreactors
- Optimizing DMSO Concentration And Freezing Technique For High Cell Density Cryopreservation In Upstream Bioprocessing
- Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges
- Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Biogen Receives Positive CHMP Opinion For TOFIDENCE™ (tocilizumab), A Biosimilar Referencing ROACTEMRA®
- Evernorth Announces Humira Biosimilar Available At $0 Out Of Pocket For Accredo Patients In June
- Alvotech Announces Topline Results From A Confirmatory Clinical Study For AVT05, A Proposed Biosimilar For Simponi® (golimumab)
- Samsung Bioepis Gains European Commission Approval For PYZCHIVA7™, A Biosimilar To Stelara (Ustekinumab)
- Sandoz Confirms European Commission Approval Of Pyzchiva (ustekinumab), Further Strengthening Immunology Offering
- Alvotech Signs U.S. Agreement To Expand Access For Newly Approved High-Concentration Interchangeable Biosimilar To Humira® (adalimumab)
- Alvotech And Teva Announce U.S. FDA Approval Of SELARSDI™ (ustekinumab-aekn), Biosimilar To Stelara® (ustekinumab)
- Fresenius Accelerates Momentum In Its (Bio)Pharma Business And Launches Tyenne, Its Third Approved Biosimilar In The U.S
NEWSLETTER ARCHIVE
- 04.25.24 -- How Continuous Manufacturing Is Shaping Biopharma
- 04.23.24 -- Novel Approaches In Chromatography Process Development
- 04.18.24 -- Optimizing Drug Delivery Systems For Complex Biologics
- 04.18.24 -- Fine-Tuning Analytical Development Strategies For Every Phase
- 04.17.24 -- Leverage Innovative Assays And Monitoring To Improve mAb Production