GMP & Chemical Manufacturing
Syngene has exclusive capabilities for GMP and chemical manufacturing from bench top volume to commercial scale and is also further expanding to cater to the growing demands. Depending on the end application, the manufacturing is done in an appropriate facility at Syngene. Our uncompromised commitment to safety and regulatory compliance helped Syngene to be the trusted partner for several global customers.
Technical and GMP Manufacturing
Syngene follows the phase appropriate chemical manufacturing philosophy, while our manufacturing facility operates under guidelines. Syngene has demonstrated capabilities and experience to manufacture batches for pre-clinical, clinical and commercial applications.
Our scale up activities are performed by a team of experienced chemical manufacturing personnel operating 24x7 and well supported by Quality Control, Quality Assurance, Environment Health Safety and Sustainability, Engineering and Maintenance and Supply Chain Management functions.
Experience with Complex Chemistry Capabilities:
We have proven track record and expertise to handle a wide range of complex chemical conversion and reagents on scale with few examples listed below:
- Asymmetric catalysis
- Suzuki reaction
- Heck reaction
- Sonagashira reaction
- Halogenation (bromine)
- Grignard reactions
- Grubb’s catalyst
- Diethyl aluminium chloride
- Diethyl zinc
- Organometallics (LDA, n-BuLi etc.)
Process and analytical validation
- Validation is the key element to any development program. Syngene is well versed in performing process validation studies for intermediates, APIs and HPAPIs. Our experience is reflected in a straight forward strategy that is followed at the right stage of the development.
- Design and control of manufacturing processes to assure, in-process materials and product meet predetermined quality requirements consistently and reliably.
- Scope includes, PCJ studies, FMEA for the process, analytical method validation, manufacturing engineering and validation batches and the associated documentation activities inclusive of the requisite protocols and reports.
- Syngene provides regulatory guidance in setting specifications, method development and validation and also conducts stability studies.