Arden

Development of parenteral formulations and processes is often multifaceted, as it has to address not only the characteristics of molecule but excipients, subsequent processing and the primary container closure system. The degree of complexity increases if the product is intended to be filled into a syringe for lyophilization or used in a self-administration device. Throughout the development process, adequate characterization and controls are needed to assure both quality and sterility of the product is maintained and delivered to the patient.

With the recent excitement generated by gene, CART and other cell therapies, the use of sterile products has expanded and so have the difficulties in formulation, shipping, container closure integrity and maintaining the viability of product at temperatures as low as -132°C.

The 2020 Arden House meeting will address current progress, lessons learned and provide a forum for discussing new areas where there is a debate on the best approach to resolve the problem. Experts in the field of formulation, process, devices/combination products, aseptic risk assessment and regulatory affairs will provide a unique learning forum for sharing experiences via case studies, practical examples, and success stories.

After attending the Arden House Conference, the participants will:

• Understand and provide practical solutions for the development of sterile drug products.
• Articulate the emerging areas of concerns (e.g. visual and subvisible particles, degradation of polysorbate) along with potential ways to address them.
• Recognize the regulatory expectations and GMP requirements along with regional differences.
• Appreciate the complexity of container closure and device development including integrity testing, extractables, and human use studies.
• Become knowledgeable in formulation and process development with associated risks with aseptic processing, for example lyophilization, bioburden control, filtration and process simulation (media fill).

Programming Committee

Sandeep Nema, Ph.D., Pfizer (Chair)
John Carpenter, Ph.D., University of Colorado Denver
Yatin Gokarn, Ph.D., Sanofi
John Ludwig, Ph.D., Pfizer
Karoline Bechtold-Peters, Ph.D., Novartis

Call For Papers

AAPS is now accepting poster abstract submissions related to the following topics of the AAPS 2020 Arden Conference:

• Analysis and Pharmaceutical Quality
• Biosimilars
• Biotechnology
• Chemistry, Manufacturing, and Controls (CMC)
• Formulation Design and Development
• Manufacturing Science and Engineering
• Patient-Centric Drug Development, Product Design, and Manufacturing
• Preformulation
• Process Development
• Protein Aggregation and Biological Consequences
• Protein Purification, Storage, and Transportation
• QbD and Product Performance
• Regulatory Sciences
• Stability
• Sterile Products

Review the Call for Papers and submit your poster abstract now!

Poster presentation slots are limited to 40 and will be awarded on a first-submitted, first-accepted basis. Authors must submit abstracts that meet the requirements outlined in the Call for Papers, as well as register for the meeting, in order to be awarded a presentation slot.

 AAPS will close this Call for Papers on January 13 at 5:00pm Eastern Time, or when the 40 slots have been awarded, if earlier than January 13, 2020.