PHARMA SPECIAL ....Piramal expands route scouting offering to meet demand

Piramal expands route scouting offering to meet demand

Piramal’s ‘route scouting’ service helps customers rapidly identify robust, cost effective routes to manufacture Active Pharmaceutical Ingredients (API). The company’s scientists offer their expertise to develop routes from late preclinical through clinical development, that are shorter and safer, and more cost effective, atom efficient, and environmentally-friendly, than conventional methods of API production. The success of this service since its launch last year has encouraged Piramal to expand this offering to additional sites while augmenting its technology platform.

Scaling up and manufacturing complex intermediates and APIs pose significant challenges when working with tight deadlines, typically associated with clinical development and commercialization of new products. To address these challenges, many pharmaceutical and biotech companies look for support from external partners. Piramal’s ‘Route Scouting’ offering seeks to fulfil this need.

Piramal’s Route Scouting Strategy focuses on a Fit for Purpose (FFP) approach that serves customers from discovery through commercialization, and through life cycle management. Introduced in 2015, this service targeted biotech clients who needed to develop robust routes to scale up medicinal chemistry processes and rapidly manufacture material for preclinical Tox. The service was initially offered out of Piramal’s Ahmedabad, India site, and was staffed with process scientists with several years of experience in developing novel chemistries. The number of clients and projects expanded rapidly, with large pharmaceutical clients also signing up for the service. The team has now tackled issues from preclinical through commercialization in the past 18 months. Some of them include:

·         "I have a medicinal chemistry route ... I now need to make my first 100-250 g for GLP tox."

·         "I need a robust route for Tox/Ph I ...  my route uses reagents that are expensive, toxic or not available in bulk."

·         "I have multiple chromatographic separations leading to significant loss in yields."

·         "I want to reduce the number of steps, or decrease the cycle time to release capacity."

·         "I am going to face generic competition and need a cost effective route, at scale, to be competitive."

Piramal is now working with more than 15 companies, from large pharmaceuticals to virtual biotechs, on over 20 projects that involve developing routes for clinical development and commercialization. Piramal has now expanded this offering from Ahmedabad (India), to its sites in Michigan (USA), Aurora (Canada), and Ennore (India). In addition, the company has married this initiative with additions to its technology platforms: Piramal has invested in (a) Advanced Flow Reactors for continuous flow route development, and (b) established a chemocatalyst and biocatalyst Centre of Excellence, where commercial catalyst technologies can be levered to provide customized solutions.

Ramesh Subramanian, Vice President, Strategic Marketing at Piramal concluded, “Piramal route scouting focuses on providing tailored solutions for clients. Once the route is developed, our clients own the route and the API can be manufactured at any site of their choice. While this flexibility is appreciated, in practice we find that a vast majority of clients choose to manufacture at Piramal. Our track record of 34 successful product launches, with 10 potential additional launches this year, gives them confidence in our abilities. In addition, they appreciate the seamless tech transfer towards larger volumes of intermediates or API, that Piramal offers. This, combined with a world class program management system, that supports clinical/commercial API supplies from our sites across the globe appeals to our collaborators. Feedback from one of our collaborators sums this up well: ‘Piramal was the only firm we found that has a dedicated service to develop novel routes cost effectively while integrating it seamlessly with downstream manufacturing facilities in North America, Europe, and Asia”

Published: February 20, 2017

http://www.specchemonline.com/news/piramal-expands-route-finding-network