Scaling up Small Molecule Drug Substance Manufacturing

On-demand CMC Webinar Series Episode 1 cover, Balancing Velocity and Security of Supply: Scaling Up from Phase II to Commercial, with James Bruno, Christopher Harley and Paul Quigley

Capabilities

Small Molecule Drug Substance

Small Molecule Drug Product

API Manufacturing

Connect with a Scientific Expert

Recorded: December 2025

About our CMC Webinar on Small Molecule Drug Substance Manufacturing

This webinar explores market demand and trends for late-phase manufacture and supply of small molecule drug substance.

Noted CMC consultant James Bruno gives a brief overview of market dynamics and the key needs of clients transitioning into late-phase and commercial small molecule drug substance production.

Dr Paul Quigley (Director, Process Development and Manufacturing, Pharmaron) outlines what is critical in scale-up: process scale-up fit for phase, process analytical technology, process safety, economy, velocity, and materials science and technology selection.

Christopher Harley (Associate Director of Manufacturing Technologies, Pharmaron) then discusses the manufacturing criteria for a successful transition to commercial manufacturing: process optimisation, green metrics, technical transfer, modelling for scale and equipment selection.

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What You’ll Learn

Attendees will gain a deeper understanding of:

Overview of market dynamics and what clients’ key needs are going into late phase and commercial drug substance production
Overview of the critical needs of scale-up consideration
Manufacturing criteria for successfully transitioning to commercial manufacturing

Meet our Speakers

Speakers:

James Bruno, CMC Consultant

James Bruno started his professional career supporting manufacturing and process improvements while attending graduate school. He moved on to formulation development where he supported a product line of clays and other thickening agents. He recognized that as he was completing his graduate work in chemistry, he was doing more on the business side and went back and completed his MBA.

His first position outside of the lab was working in business development for a European CMO. After several years in the position, he had the opportunity to work for a French CMO and start their US business. He continued working for twenty years in various CMOs and continued to increase his responsibilities.

In 2002, he started Chemical and Pharmaceutical Solutions, Inc which is focused primarily on working with small pharmaceutical companies to develop both their APIs and their dosages. He supports their chemical development as well as the regulatory requirements.

He has traveled extensively worldwide and continues to work with small pharma companies. He has authored many papers over the years and given lectures on various technologies and business topics..

Dr Paul Quigley, Director Process Development and Manufacturing, Pharmaron

Paul previously built up a new process development and drug substance manufacturing team at Quotient Sciences, was head of Technology Transfer for Johnson Matthey Ltd. and was head of New Product Introduction and Head of Technical Services for Shasun (now Sterling Pharma Solutions).

Paul has over 20 years’ experience in the Fine Chemical and Pharmaceutical industries in a variety of senior management roles, covering Technical Management of UK Sites, and Senior Project and Operational roles within a number of international organizations including ICI, Schering Plough, Clariant, Johnson Matthey and Rhodia. Paul graduated with a PhD in Natural Product Chemistry from University College Dublin in 1988 and with an MBA from Warwick Business School in 2000. He has co-authored several papers in the areas of Biocatalysis, Organic Synthesis, Polymer Chemistry and Natural Product Chemistry, and has generated several Patents in this area. Paul is a Fellow of the Royal Society of Chemistry and the Association of MBAs.

Christopher Harley – Associate Director, Manufacturing Technologies, Pharmaron

Christopher Harley is the Associate Director of the Manufacturing Technologies group at the Pharmaron Coventry, Rhode Island, US site and is responsible for oversight of project management and engineering support for technical transfer, site engineering, and process safety management. Chris has worked at the Coventry site for over 18 years, working extensively in areas of commercial manufacturing support. During this time, he was the lead receiving engineer for the technical transfer of several generic APIs and implemented several successful post approval changes to existing API manufacturing processes, targeting the improvement of CoGs. Additionally, he established the site cleaning validation and continued process verification programs following lifecycle validation principles.