08-Oct-2026
From Mouse Bioassays to Predictive Human Biology: Rethinking EPO Potency Testing
For decades, the pharmaceutical industry has accepted a fundamental compromise in biologics quality control: medicines developed for humans are often functionally characterized using biological systems that do not fully reproduce human physiology.
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05-Oct-2026
HUMAN BIOLOGY BEFORE HUMAN TRIALS
HUMAN BIOLOGY BEFORE HUMAN TRIALS
The Next Competitive Advantage in Drug Development
The industry does not have a data problem. It has a translation problem.
Drug discovery has become extraordinarily sophisticated. We can characterize molecules at atomic resolution, generate enormous omics datasets, engineer increasingly precise biologics, and apply AI across discovery pipelines.
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08-Jun-2026
AI-enabled DART uses human microphysiological systems for non-animal drug and vaccine testing
DART is a continuously learning human simulation infrastructure Regulatory bodies are actively piloting alternative methods frameworks Pharmaceutical companies are buying cruelty-free testing systems And computational analytics is no longer theoretical — it is made operational The ecosystem is ready as Human Moment
,the science is ready, the urgency is undeniable
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18-Apr-2025
Key Guidance in Adopting and Integrating Non-Animal based New Approach Methodologies
Non-animal New Approach Methodologies (NAMs) are transforming pharmaceutical and biotherapeutic research by combining human cell and tissue models with advanced computational tools. These strategies offer ethical, cost-effective, and scientifically relevant alternatives to traditional methods. NAMs are emerging as a revolutionary approach in human Readmore..
17-April-2025
Reimagining Drug & Vaccine Testing: The Feasibility of Animal-Free Platforms with Artificial Intelligence
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27-Jan-2025
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
n a landmark move, the FDA has announced plans to phase out animal testing requirements for monoclonal antibodies (mAbs) and other therapeutics, marking a significant shift in drug development. Readmore......
2024
Transcell’s scientific leadership confronts the challenges inherent in first-in-human trials and confidently introduces DART: Preparing for First-in-Human Trials – A Strategic Intervention
2023
Animal-Free Testing Strategy for Potency Assessment As Critical Quality Attribute – Digital Potency Testing – Invaluable Strategy To Support Antisera Industry
It is an animal-free technology that delivers human-relevant potency values for clinical correlation and extra benefits to antivenom producers to reduce time, effort, and resources on batch releases. Readmore..
2022
Transcell’s scientific leadership discusses new engagement models with the pharmaceutical and biopharmaceutical industry: New Approach Methodologies Concept – Creating a New World Order
The 21st century pharmaceutical and biotech sector has come a long way from its heritages in 19th century pharmacy, with differentiated contract testing services business models. Traditional contract research testing services that follow the outsourcing model offer low-cost options to pharma that come with advantages and disadvantages. With New Approach Methodologies (NAM) Readmore......
27-Sep-2016
Potency testing of cell and gene therapy products
Potency testing of cell and gene therapy products Potency is one of the critical quality attributes of biological medicinal products Readmore......
27-Jan-2025
An industry perspective on the FDA Modernization Act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development
Pharmaceutical developers are encouraged to adopt the best practices of being purposefully thoughtful about the use of animals, seeking alternatives wherever possible. Readmore......
26-Sep-2016
Precision oncology using ex vivo technology: a step towards individualised cancer care
Precision oncology using ex vivo technology: a step towards individualised cancer care Despite advances in cancer genomics and the increased... Readmore..
15-September-2016
Vaccine testing without animal experiments?
Vaccines must provide effective protection against disease without any harmful side effects. Antigen purity is a crucial factor which until now has had to be tested on animals. However, recent scientific Readmore....