CRO SERVICES

CHALLENGES FACED BY INDIAN PHARMA

COS FOR KSM AND INTERMEDIATE DEVELOPMENT

Lack of deep scientific capabilities at most Indian Pharmacos

Most of the Pharma R&D scientists do not have deep academic background to invent truly novel routes for KSMs and Intermediates

Cost is a major factor for import dependence on China. Innovative R&D can mitigate this challenge for a majority of products

Lack of Government subsidies on OPEX but Central Government’s recent PLI scheme has encouraged Indian innovative companies to undertake R&D and provide technologies and products to Indian pharmaceutical companies Experience of developing 50 APIs based on the following protocol (Evaluation / Route Selection, Feasibility & Process Intensification) API Route Selection Critical Evaluation of Prior art synthesis Proposal of non-Infringing Routes Feasibility Study KSM synthesis / Cost-effective process routes for KSMs Feasibility Study on Multiple routes (>3) Process Intensification Material buildup (250 g – 500 g) Process Optimization of Individual Steps Identification and development of novel & efficient synthetic processes that satisfy the criteria of cost-effectiveness, atom-economics, personal and environmental safety.

Design, synthetic and process optimization of cost-effective processes while ensuring that the processes are protected by intellectual property rights.

Address the limitations of current processes and further refinement to create excellent / robust commercial scale routes. A dedicated team & facility for a long-term collaboration with pharmaceutical companies on product development and commercial supply

OUTPUT & DELIVERABLES FROM THE R&D PROGRAM

TANGIBLES (IN SCOPE)

Critical review of Literature known methods and proposal of novel / non-infringing routes and Cost-Effective Routes

Selection based on SELECT guidelines and Cost-Leadership requirement

Feasibility & Process Intensifications Studies to identify an optimized process for Cost-Leadership Route

roposal / Synthetic evaluation of best routes for Key Starting Materials

Preparation of Key Starting Materials (including chiral KSMs) in-house for API synthesis

Synthesis of KSMs (not commercially available) required for the evaluation of new routes proposed

Safety Related Information (Runaway reactions / Handling Issues / Irritant nature…

INTANGIBLES

Exploration of newer chemistries (Creation of Intellectual Data Bank for diversity of chemical reactions & strategies discussed to target APIs) and development of platform technologies

Novelty is not restricted to “Design-Around” only; de novo routes and conceptually newer alternative synthetic routes are evaluated for feasibility

Identification of process-amenable and cost-effective routes which have a broader applicability than just a one-time application to a specific API

Knowledge management and creation of Experimental Databank as an IP-GOLD MINE for API companies.

Competency enhancement and integration of chemistry strengths – both from Academia and Industry

OUR STRENGTH IN PROCESS CHEMISTRY EXPERIENCE

ROUTE SELECTION PROCESS

Novel/Non-infringing synthetic routes are proposed and scrutinized for the synthetic viability, choice of reagents, cost-effectiveness and process amenability.

Telescoping, selecting reagents and reagent optimization to afford a significant reduction in COG is determined and a few routes are shortlisted for the feasibility study.

Other key factors that played an important role in the route selection were (i) cost of reagents; (ii) reduction of number of steps with multiple reactions carried out preferably in the same pot; and (iii) reagents most optimal as well as cost effective for scale-up.

Substitution of current practices with environmentally benign processes Based on the SELECT Guidelines, the entire Route Selection exercise helps in determining the most optimal route for the scale-up synthesis of the target API