We have experience in working with customers from early process research to full commercial manufacturing, and everything in between.

Our organization is fully engaged in the Project Management structure and process; cross-functional teams are assembled at project inception, and either assigned an R&D, or Manufacturing Project Manager as appropriate. If the project is at an early-stage, the R&D lead remains in oversight of the process as it transfers and scales from lab to pilot to manufacturing.

BioVectra has filed 7 DMF's, 3 VMF's, 1 ANDA, and written CMC sections for both chemical and biologic IND filings. We work closely with our clients to define the quality and regulatory requirements of each project, in terms of scope and product definition.

• Shaker flask to 25,000L commercial capacity
• Recombinant proteins (E. coli ), unique fungal and marine bacteria experience
• Production area inspected (2005) for an active DMF; process approved for commercial manufacture
• Large-scale chromatography, ultrafiltration
• 2 x 4000L chemical reactors for post-fermentation synthesis
• Ability to perform conjugation chemistries (PEGylation) and targeting chemistries

• Pilot equipment from 20L to 800L
• Large-scale equipment up to 4000L reactors
• Depth of experience in diverse synthetic chemistry
• Ability to handle cytotoxics and cytotoxic conjugates
• Experience in producing MPEGs and high-purity polymers
• Can perform post-fermentation or extraction chemistry within a single facility

BioVectra has experience in natural product isolation, extraction, and purification, that originates back to our beginnings as a producer of a number of diagnostic enzymes from plant and animal-based biomasses. Since then, we have produced a number of clinical and commercial API's and Intermediates from plant sources and have a strong competency in the area of bioactive handling.

Starting from our ability to use a full range of analytical techniques and method development experience, we work with our clients to develop product characterization specifications, in and out, as well as potential process improvements. We have experience in conducting solid/liquid separations, liquid/liquid separations, and solids processing with a full range of downstream handling capability. Our process-scale equipment, the 'Littleford' polyphase extractor/reactor/dryer with an 8000L capacity, can handle 1150Kg of dry product per batch. Our plant-extraction suite is a self-contained, explosion-proof manufacturing unit within our cGMP facility; we can handle a full range of organic solvent extractions and related process-scale column chromatography at a column capacity of 400L.

We would welcome the challenge of your extraction project, as our team understands how to structure the technical transfer, scale-up, and regulatory support program to meet your clinical development goals.

Our self-contained facility at 29 McCarville Street, Charlottetown, has been inspected by the U.S. FDA for a human injectable API, and is specifically equipped to handle animal-based biomass extractions. This facility features:

• 4000 ft2 of total manufacturing space
• Refrigeration/Freezer storage
• Air-lock separation from primary processing and finishing suites
• Extraction throughput up to 300kg/biomass/day
• Lyophilization (40 ft2 shelf space)
• Flexible utilities for added equipment
• Dedicated to single product processing