Boston Analytical To Sponsor PDA New England Chapter Event
Rapid Micro Tours
Starts at 3:30pm, preceding dinner meeting
Contact Roland Bizanek (224-433-9629 or email@example.com) for information and Tour RSVP
Registration and Social Hour
5:30pm - 6:30pm
Registration will begin at 5:30pm.
Drinks and appetizers will be available while socializing with the sponsors.
Dinner and Presentations
6:30pm - 9:00pm
Dinner will begin at 6:30pm
Presentations will begin at 7:00pm
Ed Trappler, President, Lyophilization Technology, Inc.
This presentation will discuss contemporary perspectives of development, technology transfer, routine manufacturing, and finished quality attributes for lyophilized products. Discussions will highlight the science supporting effective development and robust manufacturing, reflecting ICH Q8(R2) and process validation guidelines in the following areas:
- assessing finished product attributes
- assuring adequate product development and process engineering
- establishing a proven acceptable range for the process (boundary studies)
- controlling the major factor in process reproducibility and product consistency
Each of these discussion points will address prior conventions in meeting past expectations and the new horizons in effective development and manufacturing.
Mark Staples, Principal Consultant, Cusp Pharmatech Consulting LLC
TOPIC: Fast Track Lyophilization Development for Early Phase Programs
This overview presentation describes the means by which lyophilization can reduce risk in early phase parenteral product development. Because each project presents different challenges, several cases (disguised data) will illustrate how to expedite early phase lyophilization development. The resulting development databases can evolve into a structured understanding of products and processes that support the Quality by Design (QbD) paradigm.
Consistent lyophilization development success requires extensive applied scientific knowledge and practical experience. The lyophilization expert must design strategies to overcome the technical barriers of process and product complexity that could make lyophilization impractical for an early phase clinical product. A well-designed lyophilization program provides opportunity at an early stage of product understanding to overcome technological hurdles presented by inadequate product stability. When successfully applied, this route to a First-in-Man sterile dosage form reduces the technical risk of challenging projects while minimizing timeline delays or budget overruns.
The case examples will describe approaches that encompass:
- Establishing performance goals appropriate for early phase development
- Focused and efficient preformulation database construction
- Parallel path development to reduce project risk
- Resource and time savings through creative experimental design
- Development database design that preserves the potential to meet QbD standards