| AREA |
SKILLSETS |
INFRASTRUCTURE |
SERVICE OFFERING |
UPSTREAM
PROCESSING |
- Specialized functional team of microbiologists
& bioprocess engineers
- Industrial & academic experience in microbial &
mammallian cell culture techniques
|
- Facilities for cell banking & storage
- Dedicated microbiological labs
- Lab & pilot-scale fermenters up to 100 L in
Class 100 K area
- Homogenizer for cell lysis
|
- Microbial fermentation process optimization &manufacturing
|
DOWNSTREAM
PROCESSING |
- Specialists in protein chemistry, process
engineering & biochromatography
- Experience with intracellular & extracellular
proteins, NFF & TFF process & various
chromatography techniques
|
- Refrigerated, high-speed centrifuges
- Microfiltration & ultrafiltration systems
- Production-scale chromatography systems in Class 10 K cold room
- WFI & Pure steam utilities
|
- Protein purification process development & manufacturing
|
ANALYTICAL &
QUALITY
CONTROL |
- Dedicated analytical personnel with
biochemistry, pharmacology & analytical
background
- Experience in method development for invitro
activity assays, protein characterization &
quantitation, HC-DNA, HCP quantitation
|
- Apparatus for electrophoresis, 2D gels,
immuno techniques & endotoxin assay
- RP-HPLC
- LC-MSn with ion trap
- Microbiology, cell-culture & viral culture
facilities for assays
|
- Bioanalytical method development, protein purity profiling & stability tstudy
|
QUALITY
ASSURANCE |
- Biotechnologists with experience in validating
therapeutic proteins & vaccine processes
- Implementing quality systems for equipments,
utilities, facilities, processes & analytical
|
- Document storage & archiving facility
|
- Thoroughly documented tech packages with validated process & analytical procedures
|
