Five minutes at CPhI worldwide with …
CO/PH: What is driving the biologics market demand?
Heather Delage: The onset of a number of biogeneric products and programs is creating shifts in demand for larger scale capacities. BioVectra has over 45 years of experience working with companies from the very early stages of clinical development all the way to commercialization. Our track record, in terms of global regulatory inspections (FDA, Health Canada, and Japanese Minister of Health) means we are a fitting partner to take in programs from early stage to commercial tech transfers.
CO/PH: As a CDMO do you offer all steps of the pipeline or do you focus on some key capabilities?
HD: I would say we are an end-to-end CDMO. We are now expanding towards biologicals, but we have always been strong in complex chemistry. Our existing cGMP facilities in Prince Edward Island have a range from bench scale (grams), to low kilo scale, to larger scales as well.
CO/PH: Is there any synergy between your small molecule API expertise and biologicals?
HD: We are working on the potent components of ADCs, for example: we do not produce the antibodies yet. We have experience in molecules involved in API conjugation to biological or small-molecule entities. For example we worked on a program focused on an early stage oncology target, where a natural plant enzyme was conjugated to an antibody fragment, and we were able to undertake all of the steps. Also, we produce specialized chemical raw materials that go into biologicals production: Dithiothreitol (DTT), for example. We are interested in custom-produced regulatory starting materials and intermediates for biotech programs.
CO/PH: From the chemical point of view, what are your technological highlights?
HD: We have good experience with a broad range of chromatography purification techniques, including capture chromatography or resin-bound purification. This is another area where we employed a successful combination of chemistry and biochemistry: we have developed methods for chemical purification out of fermentation. Purification is one of the key services we offer. Also, we have experience producing high purity entities such as PEGylation Reagents.
CO/PH: Where is going BioVectra in the next future?
HD: BioVectra has been investing in its capabilities to handle complex chemistry and fermentation. We are going to open our fourth cGMP facility in Halifax, Nova Scotia early in 2018. This facility has 35,000 litres of capacity, to bring our total fermentation capacity to 70,000L, and includes a brand new fermentation train to produce recombinant proteins, and several capabilities for downstream protein purification. We already have experience in performing fermentation for the production of secondary metabolites in two of our existing facilities in Prince Edward Island. We can work with a range of expression systems, including E.coli, Pichia Pastoris, and Saccharomyces. We will also be adding cell line development capabilities to support the scale up and custom development and production.