Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.
- A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
- These Were FDA's Top Citation Issues For Data Quality In 2024
- 2024 Trends In FDA Observations For Sterile Drug Manufacturers
- Top 10 Data Auditor Statistical Software Requests
- Computer Systems Validation Pitfalls, Part 4: Inattention To Details
- How 'Explainable ML' Can Improve Process Performance
- Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data
GUEST COLUMNISTS
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
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Top 10 Data Auditor Statistical Software Requests
Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.
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Computer Systems Validation Pitfalls, Part 4: Inattention To Details
The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
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How 'Explainable ML' Can Improve Process Performance
In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.
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Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data
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.
BIOSIMILAR WHITE PAPERS
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Business Continuity Management: The Benzonase® Endonuclease Success Story
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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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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Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection10/3/2024
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies2/24/2023
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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Five Essentials For Accurate Oligonucleotide Chemistry3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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
- Dr. Reddy's Enters Into Collaboration With Henlius For Commercialization Of HLX15 (daratumumab), A Biosimilar Candidate To Darzalex & Darzalex Faspro In The U.S., And Europe
- US FDA Accepts Biologics License Application (BLA) For HLX11, Biosimilar Candidate Of Perjeta (pertuzumab)
- U.S. FDA Approves Celltrion's AVTOZMA® (tocilizumab-anoh), A Biosimilar To ACTEMRA®
- Kashiv Biosciences Announces Successful Phase 1 Results For Abatacept Biosimilar Candidate, KSHB002
- Alvotech And Teva Announce Filing Acceptance Of U.S. Biologics License Applications For AVT05, A Proposed Biosimilar To Simponi® And Simponi Aria® (golimumab)
- Formycon Receives EU Approval For FYB203 (Aflibercept), A Biosimilar To Eylea, Under The Brand Names AHZANTIVE And Baiama
- Tanvex BioPharma Completes Acquisition Of Bora Biologics, Launching New Era In Biologics Development
- Sandoz To Confirm Strategic Roadmap And Highlight Pipeline Catalysts At 43rd Annual J.P. Morgan Healthcare Conference
NEWSLETTER ARCHIVE
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