BioVectra Inc. is an Eastern Canadian supplier to the global pharmaceutical and biotechnology industries, operating from three, FDA-inspected facilities. This agile and steadily growing company has been in business since 1970, and has an impressive track-record in the quality of services and products provided to our global customer base.
Our facilities are equipped to provide synthetic organic chemistry, natural extraction of bioactive compounds from both plant and animal-based biomass sources, PEGylation and conjugation chemistry, and fermentation of a variety of molecule types.
A key component of our service is our Quality history: to date, BioVectra has submitted 9 product filings, including DMF, VMF, and CMC section preparations for both the United States Food and Drug Administration (U.S. FDA), and Health Canada. These filings have been made for both synthetic and biologic molecules, and include a human injectable API, as well as a final drug product.
BioVectra is 'bridging chemistry and biotechnology' - offering drug development companies a unique mix of skills that can be applied to molecules requiring more than one processing technique, and an ability to be a full-service, drug development partner.
We have produced recombinant proteins from E. Coli (three different expression systems in two different hosts), secondary metabolites from fungal systems, and also, unique marine bacterial systems producing small molecule entities. Handling of cytotoxic, clinical-scale fermentations can be managed to a containment level <1ug/m3 OEL. All downstream process design is done on a project-specific basis, but BioVectra can work with various modes of process-scale chromatography, as well as ultrafiltration and diafiltration.
BioVectra can also perform post-fermentation modifications unlike many other biologics CMO's. BioVectra has two, 4000 Litre reactors, and can perform synthetic modification of molecules following primary fermentation. It has experience in performing PEGylation, and conjugation with targeting agents, and can easily design process flow to allow for proper containment and handling of these complex molecules, since its cGMP facility has each of these processing suites within one overall cGMP facility.
Another basic competency of BioVectra is in the isolation, extraction, and purification of natural bioactives. Within its completely segregated facility, animal-based bioextractions can be conducted, and BioVectra currently produces two commercial API's from animal-based biomass. All materials procurement and handling fall under strict BSE/TSE risk prevention procedures.
Plant-based bioextractions are also an inherent skill in the BioVectra organization, and we can both develop and optimize extraction processes, and undertake commercial-scale extraction at a processing level of 1000 Kg biomass/day.
We aim to be your MPEG supplier of choice, and we have been steadily building our experience in terms of product development and manufacturing, to demonstrate our quality and capability in this area. We offer a product catalogue, consisting of both low molecular weight, monodispersed PEGs, and higher molecular weight MPEG reagents, suitable for direct conjugation to drug molecules.
To date, BioVectra has supplied MPEG and PEG reagents up to Phase III clinical development, and has submitted a DMF for a custom MPEG reagent on behalf of a specific client. We have experience producing MPEG Propionaldehyde, Amine, Maleimide, Epsilon Maleimide, Iodoacetamide, and Nitrophenyl Carbonate chemistries, to a high purity and low polydispersity.