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

Vaccines

Cell & Gene therapies

Recombinant proteins

mRNA

Our CMC input in product lifecycle

Pre-clinical

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