Our strict quality assurance program ensures that our medicinal products are consistently produced and controlled to the highest standards of quality. We have a Good Manufacturing Practice (GMP)-accredited manufacturing facility and meet the most stringent criteria from the US government’s Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to produce material for use in human clinical studies.
Our facility’s specialization is the GMP production of novel vaccines and gene therapy products using adenoviral vectors. Adenovirus purification is performed by anion-exchange chromatography.
We have fully-equipped, state-of-the-art laboratories, housing the following capabilities:
- GMP quality control (QC) for adenoviral vectors, including: potency/infectivity assay; titration of physical particles; characterization of vector structure; stability studies; and appropriate in-process controls.
- Preclinical and process development. FPLC and HPLC systems dedicated to the vector purification allow an efficient technology transfer for downstream processes as well as purification scale-up studies.
Hire our facilities
We can provide a range of services as an integrated package or as a stand-alone service, including the following processes:
- Construction, rescue and production of research-grade, recombinant adenoviral vectors
- Preclinical process development and scale-up
- Analytical development and validation
- GMP manufacturing for gene products
- GMP quality control
- QP release
- Quality assurance and regulatory affairs
Contact us for more information, to discuss your project or to request a quote.