Oral solid dose formulation & manufacturing considerations for high potency compounds
Stephen Brown, PhD, is the Site Director of Encap Drug Delivery, part of Capsugel’s Dosage Form Solutions business unit, responsible for the design and production of liquid fill hard capsules.
Liquid fill hard capsule (LFHC) and soft gel formulations offer optimal safety in formulation, scale-up and manufacturing of challenging compounds. This presentation will address scientific and practical aspects of process design relative to pharmaceutical development, scale-up and commercial production of LFHC-based formulations.
Specific topics that will be discussed include:
- Formulation and application considerations using lipid, liquid and semi-solid technologies
- Key considerations and steps required for safe and effective drug formulation using LFHC and soft gels
- Safe handling protocols and infrastructure considerations in commercial scale manufacturing
Predicting the regulatory landscape over the next five years
Dr Chidwick is a key advisory committee member at the European Medicines Agency (EMEA) for guideline drafting and for the European Directorate for the Quality of Medicines (EDQM)
- Will the trend for increasing regulations continue despite rising costs?
- Overcoming the challenges of rising costs and increased regulations to remain competitive
- Developing a robust communication strategy between pharma companies and regulatory bodies
Dr Keith Chidwick Pharmaceutical AssessorMHRA
Operational Excellence + Simulations: Bringing Predictive Analysis to Biotech
- Using Operational Excellence as a starting point for simulations
- Using real data from your plant historians to build predictive simulations
- How simulations can help increase throughput by 30% or more with little or no capital investment?
- Case studies with, and without, a simulation model to show the benefit to manufacturers