MONDAY, AUGUST 19 | 3:30 – 6:30 PM

SC2: Developability and Manufacturing Considerations for Bispecific Antibodies

Matthew Aspelund, PhD, Scientist II, Purification Process Sciences, AstraZeneca

Neil Mody, MSc, Scientist II, Early Stage Formulation Sciences, Dosage Form Design and Development (DFDD), AstraZeneca

Chunlei Wang, PhD, Senior Scientist, Analytical Sciences, AstraZeneca

Course Description:

Bispecific antibodies are a rapidly growing and clinically validated class of antibodies; however, multiple formats and a tedious candidate selection process such as the development of a cell line, a manufacturing process, or a formulation, are typically carried out for only one candidate and are difficult to scale up or expand to other formats/candidates. This short course focuses on challenges with discovery and development of bispecific antibodies through examining the varied aspects of developability, manufacturing, and analytical considerations to maximize the likelihood of translating a clinical candidate molecule with promising properties at an early stage of drug development into a stable, manufacturable, safe, and efficacious drug.

Topics to be covered:

• Design of bispecific antibodies: Construct types and development challenges
• Assessing molecule candidates: early developability screening and formulation selection considerations
• Examine the problems associated with Bis-mAbs from formulation to patient delivery
• Expression, purification, and scale-up
• Analytical challenges
• Case study: Development of early stage bispecific antibodies on aggressive timelines

Meet the instructors:

Matthew Aspelund, PhD, Scientist II, Purification Process Sciences, Astrazeneca

Senior level process development scientist with 10+ years of experience with management experience in early and late stage process development in bio-pharmaceutical industry. Skilled in novel process development and characterization for robustness, clinical and commercial scale GMP process transfer and validation support, technology transfer/facility fit, process validation (PPQ), regulatory filings (BLAs and INDs), Quality by Design (QbD), process impurity control strategy.

Neil Mody, MSc, Scientist II, Early Stage Formulation Sciences, Dosage Form Design and Development (DFDD), AstraZeneca

Neil Mody is an early-stage formulation scientist within the dosage form design and development department at AstraZeneca (Gaithersburg, MD USA). Prior to joining AstraZeneca, he worked as a scientist at Genentech and Tanox where he specialized in drug product formulation and fill/finish process development of early and late stage protein therapeutic programs. He has 14+ years of experience with broad expertise in formulation development and characterization strategies of peptides, fusion proteins, bispecific antibodies, antibody-drug conjugates, and monoclonal antibodies (including bio-superiors and bio-similars). In his current role, Neil and his team are responsible for leading the formulation and technology development initiations for novel protein therapeutics.

Chunlei Wang, PhD, Senior Scientist, Analytical Sciences, Astrazeneca

Dr. Chunlei Wang earned his PhD from the University of Texas at Arlington. He has eight years-experience in developing and applying analytical solutions to support the development of small molecular drugs, peptides and biologics in Eli Lilly, Bristol-Myers Squibb, and Medimmune. He is current working on biologics characterization to support CMC development.