Insights & Resources
Technical perspectives on biologics development — cell line science, process optimization, analytics, and regulatory strategy.
Five Critical Parameters in CHO Cell Line Development
When selecting a production clone for your biologic, these five parameters determine whether you end up with a robust, scalable process or a development nightmare downstream. Understanding them early can save months of rework.
Understanding DoE in Upstream Process Optimization
Design of Experiments is not just a buzzword — it's the most efficient path to a robust, transferable upstream process. Here's how we apply it across fed-batch development programs.
IND-Enabling Studies: What Your Analytical Package Needs
Preparing for your first IND submission? A practical checklist of the analytical data and documentation your CMC section will require — from characterization to method qualification.
Glycan Profiling for Therapeutic Antibodies: What to Measure and Why
Glycosylation directly impacts safety, efficacy, and immunogenicity. Here's a practical overview of which glycan attributes matter most for mAbs and how to build a characterization strategy around them.
Selecting the Right Scale-Down Model for Your Bioreactor Process
A well-characterized scale-down model is one of the most valuable assets in your development toolkit. We walk through how to design, qualify, and use one effectively throughout your program.
Stability Testing for Production Cell Lines: What ICH Q5B Requires
Stability of your production cell line is a key regulatory expectation. We break down what ICH Q5B expects, how to design a compliant stability program, and what data you'll need for your IND.
Pre-IND Meeting Strategy: Making the Most of Your FDA Interaction
A well-prepared pre-IND meeting can save months of uncertainty. Here's how to structure your briefing document, what questions to prioritize, and how to use the agency's feedback to de-risk your CMC strategy.
Have a program to discuss?
If these topics resonate with where your biologic is headed, let's talk. We're here to help you navigate development with confidence.