cGMP Production Capabilities
cGMP Production Capabilities
It is highly advisable to first optimize the manufacturing process. This process development typically results in an economic way to manufacture the product in superior yield and quality. Bachem has dedicated and experienced teams to perform this type of optimization.
Solution Phase Peptide Synthesis
Over 25 glass-lined, stainless steel or Hastelloy reactors (up to 8000 liters), fluid bed dryers and pressure filters are used for the production of amino acid derivatives and peptides in solution.
Over 15 automated reactors (up to 150 liters) are dedicated to the solid phase manufacturing of peptides.
The filter dryers have been qualified for the next level of solid phase production.
As state-of-the-art alternative to suction filters, an inverting filter centrifuge is utilized for large scale, hermetically sealed separation, washing and bottling of crude peptide.
Preparative high performance liquid chromatography equipment, conventional flash chromatography, counter current distribution, ion exchange and size-exclusion chromatography are utilized for large scale purification. The equipment in place permits manufacturing of extremely pure products in multi-kg quantities per lot.
Bachem is committed to the systematic expansion and modernization of its purification equipment in order to ensure the efficient production of even larger amounts of bulk peptide pharmaceuticals.
Stainless steel columns of up to 30 cm diameter are packed with the appropriate high performance silica separation phase. Solvent delivery is performed fully automated from tanks with a capacity of up to 2000 liters. Programmable peristaltic pumps guarantee a highly reproducible gradient flow.
In this multistep solvent extraction process, substances are separated on the basis of their different solubility in two immiscible liquids, flowing in opposite directions. Counter current distribution is a powerful technique for the purification of the intermediates and final products of solution phase peptide synthesis. Our counter current distribution systems have an extraction volume of up to 400 liters.
Our cGMP manufacturing sites are equipped with qualified solvent terminals for direct solvent delivery to the point of use. In Bubendorf, our underground solvent tanks have a capacity of up to 40 m3. Solvents are delivered and waste is collected by an in-house pipeline system in a safe, timely and clean manner.
The quality of intermediates, which have to fulfill stringent in-house standards, is monitored by validated analytical methods using state-of-the-art technology including UPLC.
Predefined physicochemical properties of the API can only be achieved by a carefully controlled isolation process. During lyophilization, a microfiltered peptide solution is frozen on stainless steel trays and the water is removed by sublimation under high vacuum in a computer-monitored drying process.
The control of microbiological contamination is a prerequisite for API manufacturing. Our temperature and humidity controlled facilities are HEPA-filtered and equipped with laminar flow devices to minimize microbial contamination.
Bachem has capabilities for the production of cGMP small molecules at the site in Vionnaz. The following services are offered:
- Process development
- Chiral synthesis
- Heterocyclic chemistry
- Metal-catalyzed reactions
- Oxidations and reductions using various reagents
- Enzymatic reactions
- High pressure reactions