CO4_2018

22 Chimica Oggi - Chemistry Today - vol. 36(4) July/August 2018 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 Panel Discussion on Custom Synthesis & Contract manufacturing NAVIGATING THE API MANUFACTURING PARTNER SELECTION PROCESS INTEGRATED APPROACH For a successful collaboration, select a partner with an integrated approach to drug development and manufacture. One that doesn’t focus on a single aspect of the program (i.e. API manufacture, drug product, etc.) in isolation, but one that takes into consideration all of the characteristics (solid state characterization, harmonization of analytical methodology, etc.) that are necessary for the eventual formulation at the outset of the program. Consideration of these factors at the beginning of the program can reduce timelines and cost. Examples of tools / approaches used by service providers who offer an integrated approach include: 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. MARK MILLAR Director and Business Unit Head, API Alcami

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