The future of the highly potent API manufacturing - Lonza perspective

Drug substance development and manufacturing service providers must respond to a number of market trends that continue to shape the pharmaceutical industry. Highly potent compounds continue to increase and now represent more than 30% of the pipeline of NCE today, driven by advances in oncology, CNS and generally more targeted therapies across other indications. Drug product approvals continue to trend towards specialty medicines with smaller and often unpredictable demand profiles. Small biopharma companies, which typically require service partners for technology, development and manufacturing, continue to dominate the drug development pipeline as well as recent new drug approvals.

A flexible and phase-appropriate infrastructure is needed to bring the next innovative medicine from concept to commercialization. Integrated capabilities in solid state characterization, particle engineering and solubilization techniques are often required to address bioavailability and other formulation challenges. Manufacturing cost minimization, supply assurance and flexibility have never been more important.

Join Lee Newton, VP & API Business Unit Head, to gain an overview of HPAPI ‘manufacturing 4.0’ investments and the innovative capabilities now in place. Case studies will be presented which demonstrate a range of solutions for HPAPI manufacturing, integrated drug substance and drug product development, and innovative business models used to meet the needs of a diverse client base.  

Lee Newton, PhD  
VP, Business Unit Head,  
API Development & Manufacturing  
Lonza Pharma & Biotech  


Lee is responsible for chemical manufacturing of small molecule API and intermediates out of Lonza’s facilities in Visp, Switzerland, and Nansha, China. Lee has a deep technical knowledge from a chemistry and manufacturing background in both API and drug product, as well as innovative research, intellectual property law and contract law. He also has strong experience in statistical analysis, ICH guidelines and NDA/ANDA requirements. Lee has worked in chemical manufacturing in the pharmaceutical industry since 2000. He holds a PhD in Organic Chemistry and a Bachelor’s degree in Chemistry from Heriot-Watt University.

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