With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.
- 6 Strategies To Protect Your Biologics Supply Chain In 2023
- Considerations For Microbial Enumeration Methods When Working With CDMOs
- EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
- What's Behind The ASTM E3263 Standard Revision?
- Considerations For Sterility Test Methods When Working With CDMOs
- FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
- FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
GUEST COLUMNISTS
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6 Strategies To Protect Your Biologics Supply Chain In 2023
Instead of automating everything — which costs a lot and doesn't solve every problem — drug makers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.
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Considerations For Microbial Enumeration Methods When Working With CDMOs
In microbial enumeration testing, the product-specific interferences are addressed during method development. The execution can vary between laboratories. This article examines general considerations, membrane filtration, and the pour plate method.
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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What's Behind The ASTM E3263 Standard Revision?
ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.
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Considerations For Sterility Test Methods When Working With CDMOs
Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.
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FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
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FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
BIOSIMILAR WHITE PAPERS
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Optimizing Lipid Formulations For Targeted RNA-LNP Applications
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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The Science Of Cell Therapy Thawing4/5/2021
A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.
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The Dynamic Regulatory Environment Of Drug-Device Combination Products11/29/2022
Examine the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.
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Explore Protein Function Using Surface Plasmon Resonance (SPR)5/20/2021
We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.
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Process Development Considerations For RNA-LNP Therapeutics9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
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Placing Drug Strategies On A Solid Foundation For Success4/21/2022
Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.
BIOSIMILAR APP NOTES & CASE STUDIES
- Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market
- Dilution Of Multiple Buffer Concentrates With One Single-Use Flow Path
- Designing Successful Viral Clearance Studies
- Outsourcing Process Dev: Key Considerations For Biopharma
- Maximize Product Recovery In Bulk Filtration And Filling Flow Paths

- The Biosimilar Leadership Playbook: 5 Tips For Success
- Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?
- The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021
- The Top 5 Biosimilar Developments Of 2020
- Will These Big Biosimilar Questions Be Answered In 2021?
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 Announces Global License Agreement With Formycon AG To Commercialize Proposed Ustekinumab Biosimilar
- First Subject Dosed For Phase 1 Clinical Trial Of Henlius’ Daratumumab Biosimilar HLX15
- AMJEVITA™ (Adalimumab-Atto), First Biosimilar To Humira®, Now Available In The United States
- The Biosimilars Forum Calls On Decisionmakers To Deliver On Humira Biosimilars
- Sandoz Receives Positive CHMP Opinion For Citrate-Free High Concentration Formulation Of Adalimumab Biosimilar
- Brand Institute's President Of Central European Market Analyzes Drug Brand Name Approvals For Biosimilars
- Hk Inno.N Licenses In Mabxience’s Denosumab Biosimilar
- Alvotech And Bioventure Announce Approval Of AVT02 (adalimumab) As Simlandi In Saudi Arabia
NEWSLETTER ARCHIVE
- 02.02.23 -- Maximizing Cell Culture Productivity
- 02.02.23 -- Why Location Matters In CDMO Selection
- 01.26.23 -- Make The Service Agreement Work For You And Your CDMO
- 01.20.23 -- De-Risking Combination Product Development For Biosimilars
- 01.19.23 -- 4 Key Takeaways For Combination Products As We Move Into 2023