Medical Devices

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)