BioVectra - Synthetic Organic Chemistry, Natural Extraction of Bioactive Compounds, PEGylation and Conjugation Chemistry

BioVectra is an eastern Canadian supplier to the global pharmaceutical and biotechnology industries, operating from three FDA-inspected facilities. Our facilities are equipped to provide synthetic organic chemistry, natural extraction of bioactive compounds from plant and animal-based biomass sources, PEGylation and conjugation chemistry, and fermentation of a variety of molecule types.

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.

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.

Product filings for synthetic and biologic molecules, APIs and final drug products

A key component of our service is our quality history; to date, BioVectra has submitted nine product filings, including DMF, VMF and CMC section preparations for both the United States Food and Drug Administration (US 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.

Cytotoxic, clinical-scale fermentations

We have produced recombinant proteins from E. coli (three different expression systems in two different hosts), secondary metabolites from fungal systems and unique marine bacterial systems producing small molecule entities. Handling of cytotoxic, clinical-scale fermentations can be managed to a containment level of <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.

Post-fermentation molecular modifications

Unlike many other biologics CMOs, BioVectra can also perform post-fermentation modifications. BioVectra has two 4,000l 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.

Isolation, extraction and purification of natural bioactives

BioVectra can perform 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 APIs from animal-based biomass. All materials procurement and handling fall under strict BSE/TSE risk prevention procedures.

Plant-based bioextractions

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 1,000kg biomass/day.

MPEG reagents and PEGylation

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.