Ophthalmic Drug Products: Tests, Methods and Acceptance Criteria

We will have two presentations:

Presentation 1 (15 Min)

Probing Oxidation-Induced Structural Changes in Human γS-crystallin
using NMR

Presented by

Yeonseong (Catherine) Seo

5th-year Ph.D. candidate in chemistry (chemical biology)

University of California, Irvine

Abstract: The human eye lens owes its transparency to densely packed crystallin proteins that maintain exceptional solubility despite minimal turnover. Over time, post-translational modifications such as oxidation can reduce their solubility, leading to aggregation and cataract formation. Here, we investigate the oxidation of W163 in γS-crystallin, a residue previously shown to oxidize upon γ-irradiation. To model this damage, we site-specifically incorporated 5-hydroxytryptophan (5-HTP) at residue 163 using genetic code expansion (GCE). Biophysical analyses revealed that the oxidized variant exhibited reduced thermal and chemical stability and aggregated at lower temperatures compared to the wildtype. 1H–15N HSQC experiments further indicated that W163 oxidation disrupts the local hydrogen-bond network, perturbing the structural integrity of the C-terminal domain. Our findings provide valuable insights to the molecular mechanisms of age-related cataracts, laying the groundwork for targeted interventions.

Presentation 2 (45 Min)

Ophthalmic Drug Products: Tests, Methods and Acceptance Criteria.

Presented By

Huahua Jian

Director of Analytical R&D

AbbVie, Irvine, CA

Abstract: This presentation will discuss the development of tests, specifications and methods for the quality control of ophthalmic products, including both small molecule and biologics drug products. The specification setting focuses on critical quality attributes (CQAs) of ophthalmic products in different dosage forms, such as solution, suspension, emulsion, and sustained release implant. Applicable regulatory guidelines will also be discussed.

Agenda: This is a hybrid event. Check-in and Networking from 4:00-4:30 PM PT. Presentation and Discussion will be from 4:30-6:00 PM PT. Login will open at 4:20 PM PT.

Important Notes: You must register to receive an emailed Zoom link for virtual attendance. You will receive the Zoom link after registration closes at noon on Tuesday, January 27th. If you need assistance logging in or during the presentation, please text Bobbie at 714 606 5907.

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Host or Publisher Southern CA Pharmaceutical Discussion Group