Future of Pharmaceutical Manufacturing: Key Insights
The pharmaceutical industry, especially in the realm of biopharma, is undergoing significant changes driven by technological advancements and regulatory focus. The sector faces challenges related to product quality, supply chain, and innovation. Key areas of focus include the pharmaceutical product space, manufacturing state, and technical issues. Embracing continuous manufacturing, process intensification, and new manufacturing modes are essential for industry growth. There is a need for flexible, efficient plants with real-time monitoring capabilities to ensure high-quality production.
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Presentation Transcript
FUTURE MANUFACTURING: BIO/PHARMA April 6, 2018
PHARMA INDUSTRY CONTEXT $1+ T/y Business with global supply chain US represents 40% of global sales Characteristics 15-20 Innovator companies, 1-2 new patented products/y/company 100 s of producers of (off-patent) generic products, most ex-US Mid-size generic company produces 50+ products US market: 90+% of prescriptions filled are generic products Products highly regulated Increasingly price controlled Cost & quality of manufacturing emerging as significant issues COGS 25+% innovators; 50+% generics Growing concerns with quality & reliability of generics supply 2
PHARMACEUTICAL PRODUCT SPACE Oral solid dose (65%+) Synthetic organics (small molecule) Injection / Infusion Drug Product Drug Liquid & topical Substance Powder inhaler Biologics (large molecule) Transdermal & other innovative delivery forms Dominance of Batch Manufacturing Mode Features: Dynamic processes end state is path dependent Limited on-line sensing & process control Batch to batch variability due to human input Low equipment / poor capital utilization
PHARMACEUTICAL MANUFACTURING STATE Continuous Manufacturing Focus by FDA & Innovators Accelerating progress in solid oral product manufacture Significant attention to small molecule continuous production Nascent effort in biologics manufacture Emerging Manufacturing Innovations Process Intensification Point of use manufacturing Generic industry very slow in adopting new manufacturing modes Opportunity to return generics industry to US Model-based product development Flexible, highly efficient plants On-line sensing, automatic control, real time release
TECHNICAL ISSUES Manufacturing System Design Focus on most common product forms: solid orals & injectables Issue: Design of flexible manufacturing systems : Innovations in Unit operations & Sensing technologies Product Development Support Most Pharma Products are Formulations Issues: Model-based development of formulation Component selection, performance prediction Manufacturing Schema Development Selection of manufacturing path, operating conditions & automation strategy Issues: Simulation of manufacturing operations Sensor network & control system design & management Manufacturing data management, lot release
BACK-UP EXAMPLE April 6, 2018
Example: Continuous Tableting Plant Capabilities Direct compression, dry /wet granulation On-line sensing of properties Automatic control Material tracking & real time release
EXAMPLE STRATEGY Partner with strong generic company: PGC, Mylan Partner with equipment & technology companies Natoli, Alexanderwerk, Enurga, etc Develop flexible facility Testing & demonstrating new technologies Development site for generic companies FDA, BARDA, DARPA support for innovation State & PRF support for facility implementation & workforce training
