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.
|Maurits Janssen, PhD|
|Head of Commercial Development,|
|API Development & Manufacturing|
|Lonza Pharma & Biotech|
Dr. Janssen earned his Ph.D. in organic chemistry from Utrecht University (NL) in 1996 and subsequently fulfilled several functions with increasing responsibility in consulting, marketing and sales, and R&D.
He has more than 15 years of experience in the custom manufacturing industry and gained significant experience with highly potent active pharmaceutical ingredients (HPAPIs)..
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