AAPS 2021 PharmSci 360 will be a hybrid event featuring a complete, pre-recorded program that will be released prior to the conference for registrants to access online at their convenience.
The full conference taking place face-to-face in Philadelphia from October 17-20, 2021 is an extension of the virtual program, which will showcase new sessions that can only take place in person. Visit us at booth #227.
The complete conference program for in-person attendance will focus on the following tracks:
- Discovery and Basic Research (DBR)
- Preclinical Development
- Clinical Pharmacology
- Manufacturing and Analytical Characterization
- Formulation and Delivery
Explore Our Event Participation
Considerations and Challenges for Full Analytical Validation of a Flow Cytometry Assays | Buyoung Koh
Development and Validation of a Rapid and Sensitive GMP-Compliant Assay for Detection of Replication Competent Lentivirus and Product-Related Impurities by qPCR | Sung Ryeol Park
Monday, October 18 9:30 - 10:00 a.m. EST
Bioanalytical Complexities in Support of Multi-Specific Therapeutics| Kelly Colletti, PhD, MBA, Scientific Director
Location: 108 AB, Pennsylvania Convention Center
Multi-domain biotherapeutics are complex molecules that require careful consideration for the design of the bioanalytical assays used for pharmacokinetic and immunogenicity characterization. For the bioanalytical assays the investigator must consider both the mechanism of action of the multi-domain biotherapeutic, as well as the potential for in vivo biotransformation. There are multiple assays that can be developed to fully characterize the PK including single domain free drug assays, intact assays, and total assays. These assays are also highly dependent on the design and availability of critical reagents that can be generated to develop and validate assays that can elucidate the pharmacokinetics of these complex modalities. The sensitivity of the assays is often also important to consider based on the potency of the multi-domain biotherapeutic and these assays may require new highly sensitive platforms.
The immunogenicity of multi-domain biotherapeutics can present unique challenges including the introduction of novel epitopes, detection of immunogenicity to multiple domains, and drug interference. These complex molecules often require additional immunogenicity tiers or assays to fully characterize the immunogenicity and neutralizing potential of the biotherapeutic.
Tuesday, October 19 11:00 - 11:45 a.m. EST
Generic Human IgG Assays for Reuse of Large Animals | Kelly Colletti, PhD, MBA, Scientific Director
Location: 360 Stage, Exhibit Hall B&C
Due to the current pandemic there is a worldwide shortage of large animals for use in nonclinical research. In order to measure early state PK for biologics, large animals are traditionally naïve to treatment with biologics. Once a biologic is administered to these large animals, they are typically not able to be used on study again due to concern over cross-reactivity with other biologics and unknown immunogenicity. We have developed generic human IgG PK and ADA assays on the gyrolab platform to determine if large animals previously dosed with biologics have measurable levels of human IgG or an existing immune response to human IgG. If they are negative for both human IgG and anti-human IgG, they can be reused for early stage lead optimization PK studies for human IgG based therapeutics.