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
Execution of experiments using our In-House Lab
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)