Succeed your biomanufacturing evolutions right first time

We provide CMC strategy & operational support
to biotech companies

Early stage biotech

  • You need to anticipate the CMC requirements supporting IND / IMPD
  • You plan to scale-up & transfer your process to a CDMO while preserving product representativity
  • Your team must integrate the GMP culture to support the development of your product

Late stage biotech

  • You plan to modify your process for industrial performance or compliance constraints
  • You need to transfer your process to a new production unit
  • You must deploy a CMC strategy based on a robust Quality by Design approach
  • You must define the validation packages adapted to the regulatory requirements

Biotech products


Cell & Gene therapies

Recombinant proteins


Our CMC input in product lifecycle


  • Quality Target Product Profile (QTPP)
  • Product and Process description
  • Scalability & industrialization
  • Technology assessment
  • Safety concern (Clearance, Sterility)

FIH: Phases I / II

  • Potential CQAs and CPPs
  • Material risk assessment
  • Development roadmap
  • Testing strategy
  • Scale-up studies
  • Aseptic processing

Pivotal to commercial

  • Quality by Design
  • Process Control Strategy
  • Contamination Control Strategy
  • Process Performance Qualification
  • Continued Process Verification
  • Ancillary processes validation (Cleaning, Single Use Systems, Decontamination)

Tech Transfer

  • CDMO assessment
  • Product and process characterization
  • Transfer documentation packages
  • Transfer Risk assessment
  • Tech transfer studies
  • Comparability

How we work

AEb anticipates and articluates process develoment, scale-up and tech transfer to GMP Environment

We familiarize

with your product and technology and challenge the current approach

We analyze

your specific regulatory environment

We provide

customized methodologies to ensure CMC project exhaustiveness and coherence

We formalize

tailored development plan and related milestones to support your CMC strategy

We Contribute

to development studies design, execution and analysis

Our partners