Future-proofing Your API

Wikipedia defines Future-proofing as:

‘the process of anticipating the future and developing methods of minimizing the effects of shocks and stresses of future events. Future-proofing is used in industries such as electronics, medical industry, industrial design, and more recently, in design for climate change.’

Why isn’t ‘future-proofing’ in our vocabulary within Drug Discovery and Development? It seems that in the R&D world, there would be a keen interest in anticipating the future. And developing methods to minimize future risks is what any organization, whether it’s a Big Pharma or small Biotech, should be striving for.

Developing a process to manufacture a new API is definitely NOT as simple as ‘repeating the medicinal chemistry route in bigger pots and stirring faster.’ Any client who hears this from a Contract Research Organization (CRO) should run away as fast as they can.

Building a knowledge base around manufacturing an API has been a core activity at Symeres for many years. Many APIs have been discovered by fruitful partnerships with clients utilizing our medicinal chemistry teams, and the medchem route is the first way to produce the milligram quantities of API. However, pressures on availability of API quickly increase, and ‘future-proofing your API’ will entail parallel ‘route scouting’ for a new process to the API as soon as positive animal data are generated. Having an experienced process team is critical to the success of this endeavor; that team must also be supported by experienced physical chemists who review the process safety of any scaled-up process. API manufacturing may also allow for the expansion of intellectual property (IP) for an API. Quickly assessing viable routes to API also leads to employing new techniques for manufacturing, such as ACS Green Chemistry Principles (twelve design principles that include reducing hazardous reagents and reducing waste), flow technology (for energetic intermediates) and late-stage functionalization. Having insight in the future manufacturing process for an API can increase its value, often positively influencing valuations for Biotech companies as they look to a future buy-out or Venture capital investment.

How would a Big Pharma ‘future-proof’ API manufacturing? In large organizations, which have integrated discovery and development teams, the seamless transfer of API manufacturing is presumably covered within these teams, with many people looking over each other’s’ shoulders. Even with all that internal expertise, Big Pharma can benefit from a CRO like Symeres by pressure-testing their process development and address questions like: Is it the ‘best process?’ Does the process have the robustness to go forward into commercial manufacturing? Our process teams can identify gaps and open new chemistry opportunities in Supply Chain management and, with the right capabilities, can also provide security during mid-phase clinical development as a second supplier of APIs.

Please do not hesitate to contact us if you would like to learn more about how we help your organization ‘future-proof’ your API manufacturing. As you look ahead in development, Symeres process scale-up teams stand ready to provide critical or supplemental capabilities for your API needs.

Below you find a recent testimonial that illustrates the impact we have had in one of our client’s programs. We look forward to hearing from you!

Testimonial:

From a Boston Biotech client, 9th Sept 2020

Hello Bas,

I’m writing to share some very good news with you, your team, and Syncom1. Today we received news that the FDA has approved [….] for the treatment of […].

I’ve been fortunate to have been collaborating with Syncom for many years now and I wanted to express my gratitude to you and your team. I’ve never relied on a contract organization for as much critical process development information for an NDA before. The high quality of work that is routinely performed at Syncom over the course of many years working together gave me great confidence that we could depend on you to help us to complete these important experiments. Your team took this challenge and exceeded our expectations. We would not have been able to successfully achieve this milestone without the dedication, hard work, and scientific excellence provided by the chemists at Syncom.

Please pass along my gratitude to everyone involved. It is a rare opportunity to work on a program that is able to so greatly benefit people’s lives. You should all feel very proud of the intellectual contributions you have made and know that people’s lives have been greatly impacted by them. “

1 Syncom now operates under the brand name Symeres

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