PCI Synthesis’ Director of Analytical Services Dedicates Lab Expansion of Outsourcing Partner: Diacel Chiral Technologies, India

Posted: July 17, 2017

API Manufacturing and Pharmaceutical Manufacturing

In late June, Dr. Mehdi Yazdi, Director of Quality Control and Analytical Services for PCI Synthesis, traveled to India to monitor its on-going collaboration with Daicel Chiral Technologies in Hyderabad, India.

After joining PCI in 2011, Dr. Yazdi has revamped PCI’s Analytical department, including improving training, ensuring consistency and building an analytical development team.  One of his newer responsibilities is to find and work with a partner who could help PCI Synthesis grow its internal commercial pipeline while the company focused on delivering for its external clients.

A portion of his responsibilities has been finding organizations that can help expand PCI Synthesis’ Analytical resources. Over the last three years, Dr. Yazdi has been looking to identify labs in India that can meet the standards that matter most to the company: PCI Synthesis’ and the FDA.

About three years ago, Dr. Yazdi and his team found the Daicel Chiral Technologies’ lab in Hyderabad, and began to conduct an intense due diligence of their people and facility. PCI Synthesis and Daicel have been working closely since then as part of an intense collaboration.

According to PCI Synthesis president, Ed Price, there was a multistep process to qualifying potential partners, ranging from using similar equipment to having a similar business model – for example, PCI Synthesis wasn’t interested in testing labs but in labs that could do method development – to having cGMP and FDA experience showing a willingness to learn and commit to meet PCI Synthesis’ standards and approach..

After identifying potential partners, “We started with Daicel Chiral on some generic analytical needs,” said Dr. Yazdi. “We worked closely on method development and validation to confirm the project would meet ICH and FDA guidelines. We found that Daicel was willing to listen and work under our approach. Over time, we developed a strong relationship.  We recognize that we need to protect PCI Synthesis’s client’s work and the company’s reputation. The Daicel team now knows how to work the PCI way.”

“We work closely with Daicel because we need to keep our internal commercial pipeline full – but you can’t compromise when it comes to analytics,” Price said.

In June, Dr. Yazdi flew to Hyderabad for one of his regular meetings with his project team because “while you can get a lot done by email, there are enough things that are better handled in person. I fly often and regularly to Daicel’s lab in order to properly manage and oversee our various projects together.”

Dr. Yazdi often travels with other PCI Synthesis team members as well. “For example, on this last trip, there was a representative from PCI Synthesis’ regulatory team since we all need to work together to coordinate and ensure that everything ties together and is ready and able to meet all relevant guidelines.”

When Dr. Yazdi arrived in June, he saw brand new R&D facilities, with state-of-the-art instrumentation and additional hires. When it was time to cut the ribbon as part of the dedication ceremony, Dr. Yazdi was surprised when his counterpart, Lakshmi Narayana, Ph.D., Managing Director at Daicel Chiral Technologies India turned to him and gave him the ceremonial scissors.

“Lakshmi insisted I do the honors as a sign of respect to the relationship we have developed between PCI Synthesis and Daicel,” Dr. Yazdi said. “We continue to work with Daicel because they understand the needs of their partners and they know how to work within cGMP. They also fully understand FDA guidelines and ICH standards. They are committed to working closely with us and for our mutual long term success.”

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About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.