CGMP Drug Substance Manufacturing
CGMP Drug Substance Manufacturing Services
Wheeler Bio’s team of experts utilize cutting-edge technology and equipment to provide CGMP drug substance manufacturing with strict control standards and processes, ensuring consistent clinical drug substance supply. Leveraging our agile facility design and highly trained operational staff, we offer drug substance manufacturing services for antibody and antibody-like formats that fall within industry standard equipment and production parameters.
Our highly experienced manufacturing team performs both non-GMP engineering drug substance production runs as well as full CGMP production runs at a 50L to 500L scale for pre-clinical and clinical supply. You can let Wheeler handle all your small-batch manufacturing needs, regardless of your clinical development stage.
Learn more about Wheeler Bio’s CGMP manufacturing services.
Multi-Modal Drug Substance Manufacturing
Portable CMC® Work Package 7
For clients who are engaging in, or preparing for, clinical trials, Wheeler’s full manufacturing capabilities can be utilized for CGMP compliant drug substance production, also with the capability for non-GMP engineering runs for pre-clinical material supply. Wheeler Bio executes drug substance manufacturing batches as a module in our Portable CMC® offerings (Work Package 7), or as a stand-alone service for processes transferred from our clients.
As part of the Wheeler Bio Portable CMC® Lead to Clinic offering, or for processes transferred from our client, Wheeler’s manufacturing team can quickly produce your drug substance to the standards required to gather vital data for IND filing and establish risk analyses for subsequent later stage clinical manufacturing.
A Full Suite of CGMP Manufacturing Services
Our modern and innovative facility contains two process trains, both with ballroom suites for maximum flexibility, utilizing single-use equipment to avoid contamination and maximize throughput in antibody and antibody-like drug product manufacturing.
The manufacturing suites include:
- Grade C Inoculation lab with Grade A biosafety cabinets
- 2 Grade D production cleanrooms
- Complete seed train equipment: incubator shakers and Cytivia Wave reactors and 50L and 500L Thermo Fisher Dynadrive Bioreactors
- Cytiva single-use downstream purification equipment(Akta ready and Akta Flux)
- Grade D Solution prep cleanrooms with Cytiva Single-Use Mixers and autoclave
- Online real time process monitoring and batch reporting through OSI Pi historian
- 10,000 Sq.Ft. of onsite CGMP warehouse space
- CRL RightSourceSM QC testing labs located within the Wheeler premises
Wheeler’s drug substance manufacturing services provide our clients with:
- Up to 500L of drug substance material
- BSE/TSE statement
- Drug substance CoT
- Executed batch records
- Engineering run performance summary
- CoA with CGMP compliance statement, or CoT for Engineering runs
From these production batches, Wheeler is able to perform:
- QC Release testing
- Non-GMP and CGMP Stability testing
- Viral clearance studies
- Reference standard (“RS”) preparation
Our top-line, high throughput manufacturing equipment ensures reliable and consistent drug substance supply and our automation tech-stack delivers a comprehensive data package to accelerate your journey to FDA approval.