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.
- Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
- 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
- Will ESG Be 2023’s Hottest Business Topic In Bio/Pharma?
- Why Location Matters
- CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance
GUEST COLUMNISTS
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Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
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 itself, 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The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1.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.
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Will ESG Be 2023’s Hottest Business Topic In Bio/Pharma?
Sustainability used to be just about saving the planet. Today it has morphed into an umbrella term for environmental, social, and governance (ESG) issues. Mentions of ESG and related topics in pharma companies’ filings more than tripled between 2016 and 2021. What are the commitments that companies are making, and which Big Pharma companies are making those commitments?
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Why Location Matters
While many factors can dictate the choice of a CDMO partner, the CDMO's location can have a significant influence on the communications channels, facilities, and skillsets that a potential partner has to offer.
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CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance
While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.
BIOSIMILAR WHITE PAPERS
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Accelerate CHO Cell Characterization With The Blazar® Rodent Panel
The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
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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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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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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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End Of End Point Assays: SPR Analytics In Vaccine Design, Development2/18/2021
Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
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Key Stages In mRNA-Based Therapeutic Development9/13/2022
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
BIOSIMILAR APP NOTES & CASE STUDIES
- Building An Army: Cell Therapy Platforms With Dr. Helen Sabzevari, CEO Of Precigen
- Explore Protein Interactions Beyond Affinity To Boost Your Academic Research
- Selecting Drug Delivery Systems For Higher Doses, Higher Viscosities, And Lower Risk
- rAAV Production Using HEK293 Cell Line And Transfection Medium
- Preparing For Future Viral Vector Manufacturing Technologies And Platforms

- 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
- 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
- Dr. Reddy’s Successfully Completes Full Set Of Clinical Studies Of Its Rituximab Biosimilar For Filing In The U.S., Europe
- Celltrion Healthcare Announces Canadian Approval Of Vegzelma® (bevacizumab For Injection) For The Treatment Of Five Types Of Cancer
- China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar To Actemra (Tocilizumab)
- Stada And Xbrane Obtain British Approval For Ximluci (Ranibizumab) Biosimilar Referencing Lucentis
- Adalimumab, Infliximab And Etanercept Biosimilars Global Market Report 2023: Sector To Reach $5.59B By 2026 At A 15.2% CAGR
NEWSLETTER ARCHIVE
- 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
- 01.12.23 -- FDA Accepts Stelara Biosimilar BLA For Review
- 01.05.23 -- Where Do We Stand On Adopting Continuous Manufacturing For Biologics?