Biologics

Biologics2018-05-22T12:22:30+00:00
  • Innovation

  • Modern Manufacturing

  • Unconstrained Business

Twenty years ago we were presented with a complex Microbial Fermentation project by a major pharmaceutical company who needed a high quality, cGMP North American supplier. Fourteen months and a capital expansion later, we entered into commercial manufacturing since then we have become an industry leader of both Small and Large Molecules, with scalable cGMP operations from 30L to 17,000L

This core competency has naturally led us into the Microbial Biopharmaceutical business, rooted in our modern Microbial Biologics facility in Windsor, Nova Scotia, Canada. This distinct facility is equipped to work with a range of biosafety level one (BSL-1) expression systems, including:

  • E. Coli

  • Pichia Pastoris

  • Saccharomyces Cerevisiae

As a rare provider with competencies in both chemistry and biologics, we offer fast-moving development companies the opportunity to streamline their supply!

Types of Drug Substances

  • Proteins
  • Enzymes
  • Antibody Fragments
  • Peptides
  • Attenuated Virus Vaccines

Process Development for Complex Fermentation Processes and Difficult To Purify Molecules

  • Analytical development for most Biologic release assays
  • cGMP Manufacture for preclinical to commercial (Scale from 30L to 17,000L) and cGMP Cell Banking
  • Post-production modifications (PEGylation, Conjugation, Liposomal Encapsulation)
  • Support Services such as ICH Stability, Reference Standards, and Formulation Development

Process Development for complex fermentation processes and difficult to purify molecules

  • Process Development

  • Cell line development
  • Upstream: from flask to fermenter
    • Scale 4 x 1.5L, 15L, 2 x 20L, 2x 30L Bioreactors
  • Purification & Isolation
    • Ultrafiltration/Diafiltration
    • Centrifugation/Homogenization
    • Chromatography
    • Tangential Flow Filtration (TFF)
  • Analytical Method Capability

  • UV/Visible Spectroscopy
  • Amino Acid analysis
  • Carbohydrate Analysis
  • Activity Assays
  • Peptide mapping; determination of disulfide linkage
    • Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis (SDS-PAGE) (reduced and non-reduced); isoelectric focusing (1D or 2D) Various chromatographic methods, such as: HPLC, Size Exclusion, and thin layer
  • Capillary Electrophoresis
  • Stability Indicating Methods
  • Endotoxin
  • Host cell protein analysis
  • Residual DNA
  • Validated Cleaning Assays
  • Residual Process Impurities methods

cGMP Manufacturing

  • Pilot Suite

  • 200L
  • 500L
  • 2,000L Palnned FY19
  • Commercial Suite

  • 100L
  • 3,000L
  • 2 x 17,000L
  • Downstream Processing

  • Refold Tank
  • Disc Stack Centrifuge
  • UF/DF, Homogenizer
  • Tangential Flow Filtration (TFF)
  • ÄKTATM Processing Skids
  • cGMP Cell Banking

Support Services

  • Reference Standard Fill and Characterization
  • ICH Stability Studies
  • Bulk Drug Product Formulation Development and Fill

Post Production Modification

  • Conjugation
  • PEGylation
  • Liposomal
  • Other Modifications

Please contact us to learn more about our Biologics capabilities.

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