Process Development
Perhaps there is no other outsourced service in our industry where customers feel less satisfied in the final outcome. That is why at Ascendex we formed our core scientific team on extensive experience in the development of pharmaceutical manufacturing processes.
Our work for global pharmaceutical and biotechnology customers includes successfully optimizing processes from medicinal chemistry syntheses to multi-kilogram scale in support of early to late stage GMP production. We adhere to a quality by design (QbD) approach; safety concerns, engineering issues, raw material availability and cost basis are systematically evaluated and mutually discussed with our customers. Tools such as Design of Experiment (DOE) and safety tests such as RC1, DSC are frequently used to assist the development of your projects. We are experienced with preclinical (NCSS or GLP) and GMP syntheses, and are up-to-date on all FDA considerations.
Our customers own all intellectual property generated during the process develop work. And Ascendex prides itself on frequent and fully transparent and effective communication with all our customers throughout and after the process is completed.
Catalyst Screening
These factors stand out for our customers in the field of Catalyst Screening: Experience and speed.
Ascendex has recognized and respected experts in the area of transition metal-catalyzed cross-couplings and hydrogenations. Our expertise is demonstrated by often-cited publications in journals such as J. Am. Chem. Soc. and Angew. Chem. Int. Ed., and authorship of well-known book chapters on these subjects including Catalytic Asymmetric Catalysis (3rd Ed. Ojima Ed. 2010) and Phosphorus Ligands in Asymmetric Catalysis: Synthesis and Applications (Börner Ed. 2008). Customers can rely on our experience in industrial scale processes and our understanding of the latest trends in the pharmaceutical manufacturing catalysis fields.
We perform rapid and systematic screening for catalyst, reaction conditions as well as heavy metal remediation agents using a union of combinatory and rationale selection approaches. With a reduced turnaround time, we deliver a ready-to-use catalysis process that could take months to develop otherwise.
Custom Synthesis
Ascendex focuses on your challenging multi-step organic synthesis. We can prepare complex small molecule products based on our your needs.
Ascendex has reliable, stream-lined delivery times of quality product (>98% AUC) accompanied by a full set of analytical results (CoA). And there is no risk to you: Ascendex works with no upfront fees.
Our team also has a blend of experience in medicinal and process chemistry. We are experienced with the identification, preparation and verification of impurity reference standards generated from a GMP process. As one of the many examples, one of our lead scientists successfully identified and synthesized over 30 complex process impurities in about six months for an oncology drug substance currently in Phase II/III studies.
Consulting/sourcing
As a part of our services above or separately as needed by our customers, Ascendex offers full and personalized consulting. We have close relationships with manufacturers around the world to offer you pilot plant scale capabilities. We can also assist you in obtaining optimal pricing for a wide range of GMP raw materials. As always, Ascendex is committed to providing and sourcing reliable product at the best pricing.