As clinical development progresses away from phase-appropriate formulations, the scale of drug substance and product increases to support automated manufacturing processes.
Each manufacturing process changes in API scale-up and the potential impact on drug product formulation and process at both substance and product needs increase. Some scientific approaches – including simulation, powder characterization, and DOE – for reducing risk in scale up will be introduced.
In this webinar, illustrative examples to mitigating scale up risks will be presented as well as:
• Performing risk assessments by stage
• Tools that can be used to de-risk during drug development
• What to look out for post phase 1
• Getting ready for process validation and registration
Speakers:
Andrew Horler
Technical SME, Oral Solid Dose
Thermo Fisher Scientific
Andrew is a biotechnologist by training after graduating from the University of Nottingham in 2007. Since then Andrew has specialised in formulation and bioavailability enhancement throughout his professional career. He has developed formulations across the pharmaceutical, OTC, healthcare, personal care and nutraceutical industries having previously held positions at 3M Healthcare, Vectura, Haemostatix, Co-Formulate, Quotient Sciences and Catalent. Andrew’s expertise lies within early phase development and he is passionate about using biopharmaceutics as a toolset for enhancing formulation performance in vivo. Andrew’s current role at Thermo Fisher Scientific is a Technical SME for Oral Solid Dosage Forms supporting customers with scoping out and designing their development programs to reduce timelines, reduce costs whilst maximising scientific value and quality.
Kevin Kane, PhD
St. Staff Scientist, R&D
Thermo Fisher Scientific
Kevin has over 24 years of experience in drug delivery, including formulation development, process chemistry, and clinical evaluation of poorly soluble APIs since 1999. Working at various CDMOs and as a consultant, he re-joined Thermo Fisher Scientific in 2019 supporting the commercial team as a technical expert on drug development and spray drying. Kevin holds a PhD in inorganic chemistry and a masters degree in polymer chemistry.
Hosted by
Maire Gerrard
Managing Editor, Custom Content
Pharma Intelligence
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