Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
- Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
- Ask The Pros — The Latest In Downstream HCP Mitigation
- How Is RIM Software Transforming Regulatory Compliance?
- Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
- A Look At Elsa, The FDA's New AI Digital Assistant
- Bracing For The Impact Of The Federal Workforce Reduction
- Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
GUEST COLUMNISTS
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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Ask The Pros — The Latest In Downstream HCP Mitigation
Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.
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How Is RIM Software Transforming Regulatory Compliance?
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.
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A Look At Elsa, The FDA's New AI Digital Assistant
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
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Bracing For The Impact Of The Federal Workforce Reduction
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.
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Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.
BIOSIMILAR WHITE PAPERS
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Five Essentials For Accurate Oligonucleotide Chemistry
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Business Continuity Management: The Benzonase® Endonuclease Success Story8/21/2024
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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Sterile Filtration And Quality Risk Management8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Process Analytical Technology In The ADC Bioconjugation Process4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer3/24/2025
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency, reliability, and innovation in bioprocessing workflows.
BIOSIMILAR APP NOTES & CASE STUDIES
- AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
- Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest
- Selecting A Platform Filter For High Concentration mAbs
- Implementation Of Multi-Column Chromatography Systems
- Accelerating Bulk Harvest Release Testing With A PCR-Based Solution
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
- Celltrion USA Announces U.S. Launch Of Denosumab Biosimilars, STOBOCLO® And OSENVELT® (denosumab-bmwo)
- Advancing Bone Health: European Commission Approves Biocon Biologics' Denosumab Biosimilars
- Sunshine Biopharma Launches NIOPEG(R) Into $10B Biologics Market
- mAbxience Announces European Commission Approval Of Denosumab Biosimilars
- Apotex Receives Health Canada Approval For Aflivu™, A Biosimilar To Eylea®, Available In Pre-Filled Syringe And Vial Formats
- Fresenius Expands Biosimilars Portfolio With The Launch Of Denosumab Biosimilars In The US
- Alvotech And Advanz Pharma Enter Into European Supply And Commercialization Agreement For Biosimilar Candidate To Cimzia® (certolizumab pegol)
- Bio Usawa Biotechnology And Bioeq AG Partner To Create Widespread Access To Vision-Saving Medicine Across Sub-Saharan Africa
NEWSLETTER ARCHIVE
- 07.03.25 -- How APBio Builds Multispecific Analytical Target Profiles
- 06.26.25 -- Formulation Is Key For Y-mAbs' Self-Assembling Antibody
- 06.19.25 -- Your helping hand in filtration for high concentration drugs.
- 06.19.25 -- A Common Sense Approach To Sustainability In The Biosimilar Business
- 06.12.25 -- 8 Ways To Drive Resilience In Oncology Drug Supply Chains