Your Trusted Supplier From Discovery to the Clinic
We are in the journey with you to create revolutionary cell and gene therapies. Leverage the scientific expertise of our scientists to streamline your program to develop, scale up, and manufacture your cell or gene therapy. We will work with you to produce exactly what you need.
All of our custom products and contract services are governed by rigorous quality assurance measures, so you can be confident in the accuracy of the data and the performance of our custom products. Importantly, our manufacturing facilities ensure that, following the success of your initial research, we can provide large-scale masses of critical, specialized reagents to assure your continued success. Work performed within our FDA-regulated facility means that you can move seamlessly into regulatory agency submissions with our regulatory affairs team as a partner.
Our policies conform with the requirements of the Code of Federal Regulations (21 CFR 820); Quality System Regulations for Medical Devices, ISO 13485:2003 Standard and ISO 9001:2008 Standard, the In Vitro Diagnostic Directive 98/79/EC and the Canadian Medical Device Regulations.
Custom Services
GMP Proteins
High-quality raw material and ancillary components for ex vivo cell manufacturing, including GMP cytokines and growth factors.
GMP Antibodies
Manufactured recombinantly to ensure consistent performance and secure supply.
GMP Cell Processing and Engineering Services
Genome engineering, activation, fill & finish for Phase I and II clinical trials.
Custom Cell Culture Media Manufacturing and Services
GMP media production, optimization of formulations, specialty media testing.
Custom Chemistry Services
Custom synthesis, chemical sourcing, chemical analysis, and custom compound libraries.
Effective partnering is central to ensuring end-users’ primary considerations of patient safety, lot-to-lot consistency, and supply chain reliability are addressed. Relationships with suppliers must be more than transactional.
Plan early and anticipate late-stage requirements to minimize disruptive changes later. Integrating RUO-grade cytokines with equivalent GMP-grade options early in your discovery process is an important part of smoothing your transition to clinical manufacturing. Take advantage of our cytokine performance consistency, supply chain, and GMP custom services.
