Abstract

In this issue we are glad to present a Panel Discussion on Custom Synthesis and Contract Manufacturing. This topic is of particular interest to our readers and we have testimony of this because of the high number of companies that showed the willingness to participate to this discussion around a virtual table.
Among others, panelists treated important topics like the partner selection process in the API manufacturing sector and the “must to have” for a CRO/CDMO to be the right partner for a pharmaceutical company; furthermore the CDMOS evolution process that are transforming them in product partners and the main trends in late stage clinical and commercial scale API manufacturing.

The following players have joined the initiative:
Alcami – Mark Millar – Director and Business Unit Head API and DP
Amri Global – Sripathy Venkatraman – Director Chemical Development and site head  Albany site
Bellen Chemistry – Charles Chen – General Manager
Capua BioServices – Elise Mous – Director Sales & Marketing/Business Development
CatSci – Ross T. Burn – Chief Executive Officer
Dr. Reddy’s Laboratories Ltd – Rashmi Nair – Technical Manager-Business Custom Pharmaceutical Services
EAG Labs – James M. Schmidt – Sr Scientific Advisor, Custom Synthesis and Radiolabeling
Fareva – Pablo Magnani – Vice President Manufacturing & Sales API
Fermion – Marko Salo – Vice President, Marketing and Sales
Johnson Matthey – Nick Shackley – Global Vice President Innovator Products and Solutions
Inventys Research Company – Deepak Birewar – Chairman & Managing Director
PCI Synthesis – Edward S. Price – President
Porton Pharma Solutions Ltd. – Raj Iyer – Chief Business Officer
Richman Chemical Inc. – Christopher Kulp – Chief Commercial Officer
WeylChem International – Mark Wehner – New Business Developer
Ypso-Facto – Kilian Kobl – Project Manager

Mark Millar
Director and Business Unit Head, API
Alcami

"For a successful collaboration, select a partner with an integrated approach to the entire drug development process"

NAVIGATING THE API MANUFACTURING PARTNER SELECTION PROCESS

The accelerated growth, and approval, of new therapies over the last two decades has put outsourcing services for active pharmaceutical ingredients (APIs) in high demand. Consequently, there is an increasing number of API and high-potency API outsourcing manufacturing sites to choose from, which makes selecting the right one that much more challenging. Several critical factors should be considered during selection of an outsourced partner.

Integrated approach

For a successful collaboration, select a partner with an integrated approach to drug development and manufacture. One ... ...