Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
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Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?
Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?
Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?
There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.
I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.
Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:
- Master bioprocess development with confidence and clarity
- Excel at scale-up and manufacturing of biologics
- Transform your innovative therapy and manufacturing technology into market-ready solutions faster
- Optimize manufacturing costs without compromising quality
- Make data-driven decisions that reduce the risk of failure
I can’t wait to help you do biotech the smart way.
Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.
Ready to transform your biomanufacturing journey? Let's dive in!
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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
228: Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation Guide
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How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until after titer targets are met introduces risk: quality attribute gaps discovered late in development force process re-optimization, extended timelines, and potential cell line reselection. Media supplementation enables earlier intervention—tuning glycan distribution as a process parameter from the beginning of cell line and media development rather than as a remediation strategy.
David Brühlmann outlines the experimental protocol for validating raffinose supplementation, including decision criteria for proceeding or terminating at each development stage. The discussion addresses process design space requirements, analytical monitoring strategy, and the experimental variables that determine when media-based glycan tuning is appropriate versus when alternative approaches are needed.
Highlights from the episode:
- When to use (and not use) raffinose in your development program, including limitations and effectiveness windows (00:30)
- Essential protocol: three experiments over eight weeks to validate raffinose for your process, with clear go/no-go criteria (04:09)
- Why individualized mannose tracking (Man5, Man6, Man7, Man8) is crucial for meaningful results (01:06)
- Managing osmolality: why it matters and how to control it in your experiment (04:36)
- Advice on scaling up: moving from small-scale screens to benchtop bioreactors and stress-testing your process (07:48)
- Three key mistakes to avoid when implementing raffinose, including lessons from analytical oversight, incomplete design mapping, and feed interference (09:08)
- Integrating glycosylation as a core part of process design, not just a secondary consideration after titer optimization (13:10)
Strategic insight:
Sequential optimization of productivity followed by glycosylation introduces development risk: quality attribute deviations discovered after process lockdown require costly re-optimization cycles. Parallel development of titer and glycan specifications from initial cell line characterization reduces this risk by establishing feasible operating windows early in the development timeline.
Are you planning your next recombinant protein scale-up? Hear how David’s rule-of-three protocol and battle-tested lessons can help you optimize faster and avoid painful late-stage surprises.
Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42
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