| Available
Services |
| |
Process Cost Analysis |
|
Sterility Testing |
| |
Fill/Finish Services |
|
MCB, WCB generation |
| |
Strain Selection |
|
Stability Testing |
| |
Assay Development |
|
Research Batch Production |
| |
Fermentation Development |
|
CMC preparations |
| |
Cell Bank Characterization |
|
cGMP Batch Production |
| |
Purification Development |
|
Validation Services |
| |
Complete Release Testing |
|
cGMP Compliance Audits/ Consulting |
| |
Formulation Development |
|
|
“Typical”
First Project |
| |
Master Agreement negotiated to
reach legal and financial terms |
| |
Project plan agreed for each project
(Purchase Order) |
| |
Audit by Customer to verify ability
to produce |
| |
Strain selection program/pre-development |
| |
Produce, test, and release MCB
and/or WCB |
| |
Product development project to
maximize yield and quality |
| |
Scale up with or without GLP production |
| |
Customer Evaluation |
| |
GMP campaign production of bulk
or finished good |
| |
Full release with stability |
A typical project can be completed in about 5 months but
will typically occur over 12 to 18 months to match client
product development milestones.
|
