Aspen API. Manufacturing capabilities
Aspen API has a heritage of serving a stable customer portfolio comprising, among others, multinationals, generic manufacturers and innovative new tech start-up companies. We have established expertise and capability to develop, scale-up and commercially manufacture complex APIs. These competencies ensure that when you engage with Aspen API, you will be working with a reliable high quality partner.
API chemical and peptide manufacturing capabilities
Aspen API specializes in complex chemical reactions and is able to combine this with developing the most efficient processes. Moreover, we have built extensive experience and a strong reputation in producing cGMP peptides. Supported by a robust quality system, we ensure a high quality product that is manufactured in compliance with cGMP, ICH and SHE regulations and standards. Through our global Aspen API network, we ensure flexibility and delivery reliability.
Expertise with HPAPIs
At Aspen API one of our strengths lies in manufacturing APIs at various production scales with a specialization in HPAPIs. Our HPAPIs are produced in units with OEB 4 and 5 classifications. We have a longstanding history of working with OEL levels as low as 0.01 μg/m3. Our heritage of manufacturing complex HPAPIs has enabled us to establish world class systems and procedures for the safe handling of these compounds.
Our cGMP production facilities are able to produce products from gram to kilo quantities to support clinical and commercial demands. All our facilities have been successfully inspected and approved by international health authorities, including the US FDA, EDQM, the Dutch Health authorities and PMDA, as well as by our customers.
Our chemical capabilities
- More than 100 stainless steel and glass-lined reactor vessels ranging from 100 liters to 10,000 liters.
- Conversion of steroidal starting material through microbiological fermentation and/or enzymes.
- Large scale purification through crystallization, filtration and chromatography.
- State-of-the-art Powder Processing and Dispensing unit for sieving, milling and micronization.
- Batches are manufactured varying from grams to > 1000 kilograms. All finished products are handled in controlled environments that are designed and qualified by independent contractors to ISO 8/class 100 000 air quality standards.
- Manufacturing of peptides, alkaloids, steroids, carbohydrates, heterocycles, narcotics, anti-coagulation compounds and cytotoxins.
- Containment capability for manufacturing and handling HPAPI products from OEL 1 ug/m³ to 50 ng/m³.