The answer might be sooner than you think and entail more transparency than you're used to.
- 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?
- How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing
- A Quality-Led Approach To Drug Production Facility Design
- Quick Takes From Takeda Austria’s Annex 1 Rollout
GUEST COLUMNISTS
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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.
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A Quality-Led Approach To Drug Production Facility Design
There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late.
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Quick Takes From Takeda Austria’s Annex 1 Rollout
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
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Navigating Grades And Sources Of Materials In Drug Manufacturing
From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.
BIOSIMILAR WHITE PAPERS
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
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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The State Of Plastics Recycling In BioPharma8/9/2023
Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.
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Optimizing Lipid Formulations For Targeted RNA-LNP Applications9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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Manufacturing Challenges With High Concentration Biologics3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
BIOSIMILAR APP NOTES & CASE STUDIES
- Protein L Affinity Resin Is Ready To Move To Manufacturing
- Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges
- Automating And Optimizing The Cell Harvesting Process
- How Membrane Prefilters Enhance Bioprocessing Efficiency
- Optimizing DMSO Concentration And Freezing Technique For High Cell Density Cryopreservation In Upstream Bioprocessing
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
- 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
- Boan Biotech Completes Phase 3 Clinical Trial For Its Aflibercept Intravitreous Injection BA9101 In China, Planning To File A BLA
- MAIWEIJIAN, First Approved Biosimilar Of Denosumab (120mg) In China
- Phase 3 Comparative Clinical Study Of Prolia And Xgeva (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints
- Samsung Bioepis Initiates Phase 3 Clinical Trial For SB27, Proposed Biosimilar To Keytruda (Pembrolizumab)
- Teva And mAbxience Announce Strategic Global Licensing Agreement For Oncology Biosimilar Candidate
NEWSLETTER ARCHIVE
- 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
- 04.14.24 -- Proactive BioPharma Supplier Management
- 04.11.24 -- The Business of Biotech: Leaders in ADC Technologies