Analytical Method Transfer: 7 steps to get it right
An analytical method can work well in one laboratory and still create problems when another laboratory takes it over. The SOP is the same. The method is the same. But…
A validated assay is not always a useful assay
A validated assay can still be the wrong assay. This is one of the most important distinctions in analytical development. Validation tells you if a method performs against predefined criteria.…
A Complete Guide to ELISA Kits for Research, Diagnostics & Drug Development
If you are developing a biosimilar, validating a biomarker, monitoring therapeutic drug levels, or conducting translational research, one thing remains constant - your results are only as reliable as the…
What is the most overlooked part of Biosimilar QC?
Most conversations about biosimilar analytical development focus on pharmacokinetics and immunogenicity, and for good reason. Both are central to demonstrating comparability. But a QC package is not complete without two…
Scaling Recombinant Protein A Production
Most updates about production milestones sound like success stories written after the fact, once everything already works. This one is written closer to the middle of the process, because that…
Why is indigenous antigen & antibody development rare in India?
When you ask most people, why so few companies in India develop antigens and antibodies indigenously, the assumption is usually about raw material access. This is not actually the constraint.The…
Why indication matters more than most teams think?
Rituximab Biosimilar PK Monitoring Most conversations about biosimilar PK monitoring treat the molecule as the starting point. Identify the drug. Select an assay validated for that drug. Run the study.…
Etanercept Biosimilar PK Monitoring
Why the Assay design starts with the molecule? Most biosimilar PK monitoring conversations in India focus on monoclonal antibodies. Adalimumab, Rituximab, Bevacizumab. These are the molecules with the largest development…
Building India’s Biosimilar Infrastructure since 2013
When the Government of India announced Biopharma SHAKTI in the Union Budget 2026 - a ₹10,000 crore national investment to strengthen India's biologics and biosimilars manufacturing ecosystem - it was…
What happens to HCP data when Biosimilar process changes?
Scale-up is the moment a biosimilar program starts feeling real. Moving from a 10L bench-scale fermentation to a 200L pilot run is a tangible sign that the program is progressing.…
Why PK monitoring needs a purpose-built assay?
Bevacizumab Biosimilar Development Bevacizumab is one of the more commercially significant biologics in India's biosimilar pipeline right now. Several companies are at different stages of development for oncology and ophthalmology…
How to solve the Top 5 HCP testing mistakes?
Insights from recent customer interactions with leading pharmaceutical manufacturersIntroductionThis week, we had conversations with QC and R&D leadership from leading biopharma companies across India.The conversation wasn't about marketing our products.…