September 17, 2014
11 a.m. to 12:00 pm EST

Sponsored by

Webinar Description:

Current Pharmacopeial guidelines for monitoring subvisible particulates (SVPs) in therapeutic protein injections have expanded into new areas as USP <787> is provided as an alternative to <USP 788>. How will these new regulations impact your particle monitoring approaches? Join us for a webinar presentation by Dr. Satish K. Singh to learn more about these new guidelines and their impact.

During the follow-up discussion moderated by Angelica Olcott, real-world examples will exemplify how orthogonal techniques such as flow imaging have been implemented for sensitive detection of sub-visible particles.

Learning Objectives:

• How new regulatory guidelines for injected protein therapeutics address gaps in prior USP <788> for sub-visible particles (2-10 microns, >10 microns).
• Strategies to apply the new criteria in formulation development, manufacturing, and quality control
• Use of Flow Imaging analysis for sensitive detection of sub-visible particles, including protein aggregates at >2 microns

Speaker:

Satish Singh, Ph.D.

Research Fellow, Group Leader
Department of Biotherapeutics Pharmaceutical Sciences, Pfizer

Satish Singh has more than 20 years of experience in the industry in product development activities ranging from oral dosage forms to ophthalmics and parenterals, encompassing small molecules and biologics, and has been involved in the submission of several BLAs and INDs. His responsibilities include leading formulation, product and process development activities for biologics and therapeutic vaccines. Satish has actively participated in the regulatory discussions around particulate matter measurement and their significance for biotherapeutics, and led the team that co-authored an industry white paper on this topic. He is a member of the USP Expert Committee working on the new USP <788> Subvisible Particles chapter focused on therapeutic proteins.

Moderator:

Angelica Olcott, Ph.D.

MFI Product Manager
Marketing, ProteinSimple

As the product manager for Micro-Flow Imaging at ProteinSimple, I am interested in how this imaging technology can be used to evaluate particle contaminants across a wide variety of protein formulations in biopharma, in addition to new areas of biological testing. Particles in protein therapeutics can trigger adverse immune responses in patients, compromising product quality and safety. As a result, new regulatory guidelines require expanded testing on the levels of sub-visible particles using orthogonal techniques such as MFI, and evidence of the control and identification of product-related impurities.

Cost: No cost