Biologics & Advanced Therapy Manufacturing
We bring manufacturing science and CMC depth to the hardest modalities — biologics, cell and gene therapy, and beyond — from process development and tech transfer through commercial supply.
Advanced therapies fail at the interface of science and scale. Our MSAT and CMC practitioners have taken biologics and cell & gene therapy programs from development through tech transfer and process characterization into GMP manufacturing. We de-risk scale-up, author the CMC package, and troubleshoot the process so your supply keeps pace with your clinical and commercial timelines.
Dev → GMP
Tech transfer & scale-up
CMC
Development to commercial
CGT
Cell & gene therapy depth
How we help
MSAT, CMC, and manufacturing science for biologics, cell & gene therapy, and next-gen modalities.
MSAT & Manufacturing Science
On-the-floor process support, troubleshooting, and continuous improvement.
CMC Development & Strategy
CMC packages, comparability, and control strategy for biologics and CGT.
Technology Transfer
Site-to-site and dev-to-GMP transfer to internal plants or CDMOs.
Process Characterization & Scale-Up
Upstream/downstream development, characterization, and scale-up.
Cell & Gene Therapy Manufacturing
Process and analytical support for viral vector, cell therapy, and next-gen modalities.
Analytical Development
Method development, qualification, and transfer for advanced modalities.
A clear path, start to finish.
Characterize
Process characterization, CQAs, and control strategy.
Transfer
Tech transfer to internal or CDMO manufacturing sites.
Scale
Scale-up, process validation, and MSAT support on the floor.
Sustain
Continued verification, deviations, and lifecycle CMC.
The people behind the work.
Vetted, screened, and matched to your exact needs — on a contract, interim, or permanent basis.
Held to the highest bar.
We work to the standards your regulators, auditors, and customers expect.
Industries this practice serves
Let’s talk about biologics & advanced therapy manufacturing.
Tell us what you’re working on and we’ll show you how this practice can help.