Protein Therapeutics

GMP Protein Manufacturing Services

Put our GMP expertise to work for you.

column chromatographyOur expertise with protein-based therapies extends from the discovery of IL-2 and covers over 30 years of GMP manufacturing support for biopharmaceutical companies and US government clients.  ABL supports industry, academic and government clients developing

  • Monoclonal antibodies
  • Glycoproteins
  • Virus-like particles (VLPs)
  • Fusion proteins
  • Immunotherapeutics
  • Critical reagents for diagnostic assays
  • Other cutting edge recombinant protein therapies

Every protein product brings a unique set of challenges during development and manufacturing scale-up to reach the clinic.  From the initial technology transfer discussion to the shipment of vialed product, ABL’s scientific and operations staff are focused on developing a robust, reproducible, GMP-compliant process that delivers high quality material at maximum expression and recovery yields.  We can work with clients to optimize specific unit operations during process transfer, or create a comprehensive product development plan (PDP) outlining each step of development and scale-up, highlighting technical, regulatory and schedule risks.

Services

  • Cell line development
  • GMP master/working cell banks (MCB/WCB)
  • Transient transfection scale-up
  • Upstream cell culture development
  • Downstream purification development
  • Manufacture of toxicology material
  • GMP manufacture of drug substance (DS)
  • Aseptic fill/finish of drug product (DP)
  • Analytical development and qualification
  • Release and stability testing

Capabilities

  • Mammalian Cell Culture Process Focus
  • Multiple Sartorius BIOSTAT® STR Single-Use Bioreactors – 50L, 200L, 400L
  • Column Chromatography – Multiple GE AKTA Systems – Explorer, Pure, Ready, Process
  • TFF – UF/DF
  • Multiple GMP cleanroom manufacturing suites with dedicated HVAC, airlocks and access control
  • CMC/Regulatory support
  • Aseptic Fill/Finish
    • Up to 10,000 vials/batch

Experience

  • Monoclonal antibodies
  • Glycoproteins
  • Virus-like particles (VLPs)
  • Fusion proteins
  • Enzymes
  • Other recombinant proteins

Quality Systems

ABL’s U.S. location adheres to Good Manufacturing Practices (GMP) standards and is working toward ISO 9001 accreditation.

ABL welcomes client audits and keeps a permanent audit record detailing each audit performed, results, corrective actions taken, and follow up verification of the final outcome.