Topical products are usually semi-solid in nature and typically contain more types of excipient than other types of drug products. Many of these excipients can, if used inappropriately, adversely affect the process used to manufacture the product.
In this webinar, featured speakers will discuss the effect of excipient choice on the process of manufacturing topical products. The effect of the following excipient types will be discussed: surface active agents, preservatives, polymer choice and skin penetration enhancers.
Along with excipient selection, process understanding will have an impact on the success of commercial manufacturing. When scaling up a topical product manufacturing process from bench or pilot scale in preparation for process qualification, there are opportunities to maximize process understanding and optimization with a limited number of batches or trials.
Considerations include the following:
- Understanding equipment differences and their potential impact on the process
- Extensive sampling throughout each unit operation to understand process parameters and process efficiency
- Performing key tests on the spot to understand required duration for individual process steps
- Designing the testing plan to balance testing resource with knowledge benefit
- Process stretching studies on key process parameters
Register for this webinar to learn about the effects of multiple excipient types on the process of manufacturing topical products, and how maximising process understanding can streamline entry into commercial manufacturing. Come prepared with questions for our speakers to ask during our dedicated Q&A session.
Daryl Bassett, Product Owner, Bora Pharmaceuticals
Daryl has been working in the pharmaceutical industry for over 20 years. He has held various roles in R&D, quality, and technical services. He’s been
involved in technology transfer and scale-up activities for the last 10 years, including supporting routine commercial production and troubleshooting of topical products.
Daryl currently is in a Product Owner role within the Technical group at Bora Pharmaceutical Services Inc.
Dave Barnes, Ph.D., CEO/CSO, Velesco Pharmaceutical Services
Dave graduated with a degree in pharmacy from The School of Pharmacy at the University of London (“The Square”). After completing a year-long pharmacy internship, he returned to The School of Pharmacy to undertake a Ph.D. in Pharmaceutical Sciences.
Dave then joined Pfizer’s R&D division in Sandwich, England, and for the next 13 years worked on developing drug products of locally discovered molecules, from early pre-formulation through scale-up and transfer into production sites in Europe and the US.
In 2001, with the acquisition of Parke-Davis, Dave moved to Ann Arbor to complete the construction and commissioning of the new Pharmaceutical Sciences building (550/TDF). Upon the successful start-up of the facility, he moved to the Clinical Trial Materials department managing activities across the Ann Arbor, Kalamazoo and Groton, CT sites.
In 2008, with the closure of the Ann Arbor facility, Dave teamed up with Gerry Cox to set up Velesco Pharmaceutical Services, which provides formulation and analytical development services for small-to-medium-sized pharma companies as well as the provision of small-scale, non-sterile cGMP supplies for early stage clinical studies.
Who Should Attend?
This webinar will benefit senior professionals in the pharmaceutical industry, with relevant job titles including:
- Formulation Scientists
- Drug Product Process Development Engineers
- Tech Transfer Specialists
- Scale-Up Specialists
- Project Managers
- Manufacturing Director
- Operations Management
What You Will Learn
Register for this webinar to learn about:
- How excipient choice can lead to processing issues, especially at larger scale
- The types of excipients that are most likely to invoke processing challenges
- How to solve processing issues that are the result of excipient choice
- How to maximize process understanding when scaling up manufacturing
Bora Pharmaceuticals is a premier international cGMP CDMO specializing in complex oral solid dosage (tablet & capsules), liquids (solutions, suspensions, & nasal sprays) and semi-solids (creams & gels) pharmaceutical Rx and OTC products for late-phase clinical through commercial manufacturing and packaging. Bora owns and operates three state-of-the-art cGMP manufacturing facilities (Taiwan and Canada) built to the highest international standards for manufacturing, packaging, R&D, and analytical testing.
We can handle high-potency compounds, solvents, flammables, and IR/SR/ER release profile products.
Our Taiwanese facilities are USFDA, MHRA, TFDA, Jordan FDA, and GCC (Gulf Cooperation Council) inspected. Our Mississauga, Canada site is approved by all major regulatory agencies, including USFDA, Health Canada, ANVISA, EMA, PDMA, and the Japanese Ministry of Health. Our last USFDA audits have had no findings.
Our sites deliver to more than 100 markets around the world, including the US/Canada, EU, Southeast Asia, Middle East, and South and Central Americas. All sites are TAA compliant. Our packaging lines are fully serialized. Our sites have over a 98% on-time delivery record!
Bora Pharmaceuticals has an extremely solid financial foundation and experienced management team, with over 20+ years working in the pharmaceutical industry.
Velesco Pharma was formed in 2007 by former Pfizer Michigan R&D (Pharmaceutical Science) colleagues. Velesco’s team has decades of experience in both early-phase and later-phase drug development. The colleagues were trained at the various legacy big pharma research and development facilities, including Pfizer, Warner Lambert, Parke Davis, Upjohn and Pharmacia.
Velesco operates from state-of-the-art facilities and has maintained a focus on providing drug formulation, analytical method development and cGMP clinical trial materials. Our true differentiating factors are summarized as:
- Expertise and experience — with a team that has worked on over 400 drug development programs
- Flexibility — nimble processes and a team that is responsive, accommodating, and eager to assist our clients
- Personalized partnerships — we treat your project like it’s our own and identify solutions for challenging issues
- Velocity — we’re committed to getting your compound to the clinic and on the market rapidly. Our size, capacity, and expertise allow us to accommodate changes swiftly while maintaining control and quality
Velesco operates from two locations in Wixom, MI. Non-GMP formulation and analytical method development work, along with GMP release, stability testing and method qualification, is performed in our development laboratories. Clinical manufacturing activities are executed at our new GMP facility.