MilliporeSigma

Flexible Mammalian Process Development

Scientist in a white lab coat working in process development laboratory

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.

“Merck 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.

Scientists in white lab coats working in analytical testing laboratory

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


Our Track record

Contact us and discuss your timeline and strategy with our process development experts today.

 


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