Flexible Mammalian Process Development
Whether you need full process development or need to transfer your process to our mammalian biologics facility at any stage, we build on your existing cell line or existing process. We take a risk-based approach and implement a well-balanced CMC strategy that combines speed and cost while maintaining highest quality standards.
By leveraging your process and molecule data, we identify potential process improvements and offer strategic choices for optimization. Our platform technologies and 35+ years of experience in process development enable us to streamline the process, reducing time to market.
“MilliporeSigma respected our timeline and we initiated our clinical trial as planned. The skill and experience of the team was critical in identifying ways to accelerate the project and properly balance speed and risk.”
- Client quote about our CDMO services
Mammalian process development services
- Upstream & downstream process development or transfer
- Media and feed screening
- Master cell bank manufacturing
- Formulation development
- Scale-down model for process optimization
- Accelerated, direct scale-up model
- Process characterization
- Process validation
Simplified downstream purification platform
We use mixed-mode chromatography to replace the typical two-step polishing of cation and anion exchange chromatography. Anionic mixed-mode chromatography combines anion exchange and hydrophobic interaction to remove all impurities including host cell proteins, DNA, and aggregates in a more efficient manner with equivalent quality. Minimizing the number of chromatography steps reduces material needs, resulting in COGS reduction on purification.
Strong analytical expertise
Collaborate with a dedicated team of professionals with deep expertise in analytical method development and validation, quality control, and regulatory standards. Taking a phase-appropriate approach, we adapt your analytical panel across clinical phases and commercialization, meeting the requirements for your regulatory filings and approvals.
Your analytical needs are covered across the entire product lifecycle, including mammalian cell line development, process development & transfer, formulation, panel optimization, validation, and drug substance release.
Our analytical capabilities span a wide range of techniques:
- In-process control
- High-throughput methods
- Platform methods
- Custom method development
- Binding assays (ELISA, Biocore)
- Extended characterization
- HCP coverage & characterization
- Multi-attribute method
- Troubleshooting
- Comprehensive mass spectrometry expertise
Related Product Resources
- Mammalian Biologics CDMO Services to bring your program to the next stage
Where ever you join us, our experts ensure flawless tech transfer and robust, scalable processes for your large-scale manufacturing needs.
- A Molecule’s Journey Break Down Roadblocks to Clinical Success
A guidebook for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully bring a molecule to the clinic.
- Optimize the Formulation for a Monoclonal Antibody
This case study shows, how our innovative, custom solutions and decades of expertise allow to effectively balance cost, speed and risk when optimizing drug substance formulations in an accelerated timeframe.
- Reduce the Level of Host Cell Proteins in the Bioreactor Harvest
Learn how conceptualized and effective approaches help to address process development challenges such as HCP removal, in an accelerated timeframe.
- Scale your Process Directly from 3L to 2000L
In this case study we showcase how to advance a drug candidate into the clinic and ultimately onto the market faster.
Our Track record
Contact us and discuss your timeline and strategy with our process development experts today.
Request information from our process development experts.
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