Chemical Support for Synthetic Development and Commercial Projects

products-servicesUbichem Pharma Services
February 28th 2013

We offer the following services:

Process R&D
Strong emphasis on process research and development minimizes the risks associated with the scale-up of medicinal chemistry routes, giving our customers the confidence that their chemistries are viable for commercial scale production. We have expertise in both chemistry and process development, addressing such issues as route selection and safety evaluation, availability and cost of key raw materials, process optimization and scale-up. Our technical package enables smooth technical transfer of the process to facilitate large scale production.

Intermediate Manufacture up to Commercial Scale
At Ubichem Pharma Services we provide custom synthesis services on lab to pilot plant scale, while our sister company, Ubichem Pharma Manufacturing, provides intermediates and other fine chemicals up to commercial scale. With particular expertise in heterocyclic and organometallic chemistry, we supply starting materials and intermediates from grams to 100 tons.

cGMP API Manufacture
At Ubichem Pharma Services, we have regulatory approval for cGMP manufacture of APIs and intermediates for clinical trials. Clients regularly visit our facilities for formal or informal audits, and we are happy to provide detailed information in relation to our quality systems. Our facilities include a class 100,000 Laboratory, a Kilo Laboratory and a Pilot Plant.

Radiochemical Synthesis
Our isotope synthesis group has vast experience in the synthesis of labeled compounds for use in pharmacokinetic, metabolic and other biological studies. The synthetic laboratories and a dedicated analytical laboratory provides radioactive labeled compounds – incorporating 14C, 3H, cGMPradiosynthesis for microdosing studies with a comprehensive QC and analytical package, modern purification & analytical techniques.

Pharmaceutical Chemistry Support
Ubichem Pharma Services offers services to support the synthetic development projects we undertake for our customers: identification, synthesis and characterization of impurities and reference standards, stress tests, accelerated and long term stability studies, based on ICH guidelines. We also support our customers with crystallization services, which include salt screening and optimization of the crystallization conditions; polymorph screening services complement this work.

Discovery Chemicals Catalog
We have particular expertise in the synthesis of heterocyclic compounds and offer a broad range of novel building blocks for use in medicinal chemistry programs. The listed compounds are typically available ongram scale from stock, with larger quantities, being made on request. In addition to the compounds listed, we offer synthesis of analogues.

For more information or to discuss chemical support for synthetic development and commercial projects please contact us directly.