Process Expertise

Our protein scientists and engineers have successfully developed dozens of recombinant proteins and monoclonal antibodies (mAbs) through preclinical, clinical and commercial stages, including post-approval changes and biosimilars development.

We have worked with proteins from a variety of expression systems and with various posttranslational or chemical modifications (PEGylation, Fc fusions, hyperglycosylation, radiolabeling, enzymatic processing, etc). We have expertise in both upstream and downstream processing technologies, from strain development through aseptic fill/finish.

Process Development

New product strategic planning- taking your product from concept to clinical trials (also see Strategic Planning)

Statistical experimental design and data analysis to support QbD and PAT efforts

  • Upstream processing- optimizing productivity, developing assays to increase process understanding, and increasing yield
  • Downstream processing- selection and optimization of chromatography methods, refold alternatives, step or linear gradient elutions, UF/DF, Impurity removal

Composing and reviewing protocols related to development and characterization efforts for new or established processes

Experience with a variety of upstream platforms, including:

  • CHO
  • HEK-293
  • D. parva
  • E. coli
  • S. cerevisiae
  • P. pastoris

Experience with a variety of downstream technologies, including:

  • ion exchange
  • HIC
  • size exclusion
  • hydroxyapatite
  • Protein A and many other affinity chromatographies

Experience with many separation technologies, including:

  • tangential flow filtration
  • hollow fiber filtration
  • ultrafiltration
  • depth filtration
  • centrifugation
  • flocculation
  • precipitation
  • liquid extraction
  • crystallization

Experience with various Active Pharmaceutical Ingredient (API) and final dosage forms, including:

  • Proteins
  • Peptides
  • Nucleotides
  • PEGylated proteins and peptides
  • Drug / device combination products (including controlled release systems, such as PLGA, polyanhydrides, PEG-PLA, and activated carbon carriers)

Formulation Development

Composing and reviewing protocols related to development and characterization efforts for new or established formulations

Statistical experimental design and data analysis:

Evaluation of final product presentation:

  • Vial, cartridge, and pre-filled syringe final product presentations
  • Liquid, lyophilized and dry-powder fill/finish
  • Solid dosage final product presentations

Technology Transfer and Scale-up

  • Development of strategy and approach to streamline scale-up efforts
  • Composing and reviewing scale-up documents, including:
    • Pilot scale characterization protocols and reports
    • Small scale model protocols and reports
    • SOPs, batch records, and related GMP documents
    • Process flowcharts
    • Commissioning protocols
  • Development of dimensionless correlations and scaling factors
  • Troubleshooting differences in process performance at different scales
  • Risk assessments of process methods, process additives, and leachables/extractables
  • Gap analysis
  • Specification development and parameter classification
  • Technical investigation of deviations and out-of-specification results
  • Hands-on assistance during engineering runs, commissioning, validation, and other process
  • implementation activities (person in plant)
  • Assistance with Facility design
  • Long-term planning and process feasibility (Project Management)

Process Validation

  • Process and related equipment validation, including utilities, computer systems and other automated systems
  • Writing and review of validation master plan and validation protocols
  • Risk assessments and gap analysis
  • Technical investigation of deviations and out-of-specification results
  • Writing and review of CMC sections for global regulatory submissions
  • Hands-on assistance during validation activities (person in plant)
  • Master planning, scheduling and tracking of validation efforts

Contract Manufacturing Liaison

  • Solicitation (eg., RFI, RFP), evaluation, and selection of contract manufacturer
  • Comprehensive and strategic coordination of all activities at contract manufacturer
  • Hands-on assistance during tech transfer and process implementation activities at contract manufacturer (person in plant)