A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.
- 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
- The Matryoshka Model: The New Face Of Contract Packaging In Pharma
GUEST COLUMNISTS
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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.
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The Matryoshka Model: The New Face Of Contract Packaging In Pharma
Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.
BIOSIMILAR WHITE PAPERS
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Manufacturing Challenges With High Concentration Biologics3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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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.
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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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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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Revolutionizing Drug Discovery From "Undruggables" To AI6/10/2024
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
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
- 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)
- Biocon Biologics Receives Health Canada Approval For Yesafili™ (aflibercept); First Global Launch Scheduled For July 2025
- Kashiv BioSciences Announces Positive Topline Results From Confirmatory Efficacy Study Of ADL-018, Biosimilar Candidate To XOLAIR (omalizumab)
- Bio-Thera Solutions And SteinCares Expand Partnership To Commercialize Biosimilars For Treatment Of Inflammatory Diseases Across Latin America
- Amneal Highlights Positive Topline Results From Confirmatory Clinical Study Of Biosimilar Candidate To XOLAIR® (omalizumab), Developed By Kashiv BioSciences
- Positive Top Line Results From Confirmatory Efficacy Study For Proposed Biosimilar To Xolair® (omalizumab)
- Biocon Biologics Collaborates With National Cancer Society Malaysia
NEWSLETTER ARCHIVE
- 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
- 06.06.25 -- Master The Final Critical Step In Drug Manufacturing