The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.
- Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation
- New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
- A Justification For Using In-Process Controls In Place Of Cleaning Validation
- 7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
- Deploy AI To Become A cGMP "Special Agent" With A License To Care
- 11 Key Contributing Factors For Maintaining Sterility Assurance
- ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction
GUEST COLUMNISTS
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Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation
API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.
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New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.
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A Justification For Using In-Process Controls In Place Of Cleaning Validation
This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.
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7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
Working with a CDMO doesn’t always go as planned. This article outlines the factors that will impact project success and set up a “win-win” relationship.
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Deploy AI To Become A cGMP "Special Agent" With A License To Care
Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."
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11 Key Contributing Factors For Maintaining Sterility Assurance
Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.
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ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction
This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.
BIOSIMILAR WHITE PAPERS
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
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.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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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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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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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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The Evolution Of Antibody-Drug Manufacturing6/3/2024
Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the 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
- Formycon Receives EU Approval For FYB203 (Aflibercept), A Biosimilar To Eylea, Under The Brand Names AHZANTIVE And Baiama
- Sandoz To Confirm Strategic Roadmap And Highlight Pipeline Catalysts At 43rd Annual J.P. Morgan Healthcare Conference
- Henlius Broadens Access To Multiple Biologics In Emerging Markets
- Teva Announces Collaboration To Commercialize Formycon's Biosimilar Candidate To Eylea® (aflibercept) In Major Parts Of Europe And In Israel
- Samsung Bioepis And Teva Enter Into A Strategic Partnership For Commercialization Of EPYSQLI® (eculizumab-aagh) In The United States
- Fresenius Kabi Canada Has Received A Health Canada Notice Of Compliance (NOC) For Otulfi™* An Ustekinumab Biosimilar
- Expanding Horizons: Xentria Achieves Milestone Success With Biosimilar Development
- Formycon And Fresenius Kabi Canada Receive Health Canada's Approval For FYB202/Otulfi (ustekinumab), A Biosimilar To Stelara
NEWSLETTER ARCHIVE
- 01.23.25 -- How To Establish A Win-Win Relationship With Your CDMO
- 01.16.25 -- Become A cGMP "Special Agent" With A License To Care
- 01.09.25 -- AP Biosciences' Approach To Complex Antibody Manufacturing
- 01.02.25 -- Cell Culture Trends To Watch In 2025
- 12.19.24 -- How To Ensure 21 CFR Part 11 Compliance