Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.
- Suppliers Pushing Novel Analytical Methods Testing Forward
- Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL?
- 3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche
- Survey Says Downstream Biomanufacturing Bottleneck Is Over
- The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
- Computer Systems Validation Pitfalls, Part 1: Methodology Violations
- Sterility Assurance: The Fundamentals
GUEST COLUMNISTS
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Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL?
When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.
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3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche
Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.
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Survey Says Downstream Biomanufacturing Bottleneck Is Over
BioPlan's 21st annual survey finds that downstream processing capacity constraints are at their lowest reported in years.
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The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
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Computer Systems Validation Pitfalls, Part 1: Methodology Violations
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.
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Sterility Assurance: The Fundamentals
Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.
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Expert Voices: Why Aren't QC Labs Fully Automated Yet?
Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.
BIOSIMILAR WHITE PAPERS
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Inspection Of Injectable Products For Visible Particulates8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
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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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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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The Role Of Extractables Data In The Adoption Of Single-Use Systems8/29/2024
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
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Development And Regulation Of Veterinary Monoclonals2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
BIOSIMILAR APP NOTES & CASE STUDIES
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
- Fresenius Kabi lLaunches Tyenne7®*, The First And Only Approved tocilizumab Biosimilar In Canada
- Henlius Shines At CPHI Worldwide 2024, Expanding New Opportunities For International Collaboration
- US FDA Approves Dong-A ST's IMULDOSA (ustekinumab-srlf), A Biosimilar To STELARA
- EMA Accepts Marketing Authorization Applications For AVT03, A Proposed Denosumab Biosimilar
- European Medicines Agency Confirms Acceptance Of Marketing Application For AVT03, A Proposed Biosimilar To Prolia® And Xgeva®
- Bio-Thera And Richter Execute Exclusive Commercialization Agreement For BAT2206, A Proposed Stelara® Biosimilar, For EU countries, UK, Switzerland And Other Selected Countries
- Biocon Biologics' Commissioned Report Highlights Pathways To Increase Adoption Of Biosimilars In LMICs
- Teva Prolia® (Denosumab) Biosimilar Candidate Is Accepted For Review By U.S. FDA And EU EMA
NEWSLETTER ARCHIVE
- 10.18.24 -- Resources For Trouble-Free Validation
- 10.17.24 -- Outsourcing Considerations For Complex Protein Development
- 10.16.24 -- Curious About Diverse Antibodies?
- 10.10.24 -- Tips For Addressing Vaccine Demand – No Matter Your Therapeutic Background
- 10.10.24 -- Upping Flow of Advanced Technologies Into Commercial Manufacturing