|
Teamed for a lasting partnership
Since 1997, KABS offers a broad range of analytical services,
formulation development, and pilot manufacturing to the bio-pharmaceutical
industry, worldwide.
Originally developed as a testing reference laboratory, KABS steadily improved
its facilities, instrumentations and quality systems over the years in response
to specific demands for advanced analytical R&D techniques
required for the successful development of solid,
colloidal and liquid dosage forms.
Since 2004, we built four cGMP
compliant pilot plants:
• Plant 1-a is configured to prepare small lots of tablets, capsules, gels, ointments,
creams and solutions.
• Plant 1-b is a sterile suite dedicated to the preparation of injectable products,
both liquid and lyophilized. Both plants 1-a and 1-b are totally segregated via independent
and disposable HVAC and isolator systems allowing for the handling of potent products.
We solved the problems associated with | |
handling of potent products by developing disposable
HVAC systems coupled with integral cleaning validation
programs proving that all surfaces of the plant are free from contamination using highly sensitive LC-MS-MS detection.
• Plant 2-a is an aseptic pilot fermentation unit equipped with three 1,900 L fermenters
and associated seeding equipment.
• Plant 2-b is configured to extract and purify active ingredients from fermented biomass
at kg scale. Biomass may be separated from target components, using our centrifuges or
ultrafiltration units, and then purified by column chromatography, heterogeneous or homogeneous
precipitation and recrystallization. We use 120 L and 500 L glass lined reactors to execute
delicate synthetic routes or difficult recrystallization, at up to kg scale.
Each plant is cGMP compliant and is operated with four
separated HVAC systems.
|
|
