1	Quality Perspectives for Compound Storage Dania Yaskanin, Ph.D Manager, Corporate Compound Logistics Center Johnson and Johnson Pharmaceutical Research and Development, L.L.C.
2	Outline 1) Library description 2) Compound handling 3) Production materials a) Neat compound vials b) Microplate seals c) Review of plate vs. sealed tube storage 4) Process validations a) Thurnall tube store b) Solvent handling 5) Future directions a) Replenish solubilized compounds b) Recover neat compounds from solubilized c) Web-based review of compound quality
3	Library Composition ·Approximately 10⁶compounds Distributed over 4 locations 42% are neat Solubilized compounds are stored in plates and/or tubes
4	CCLC Compound Handling Neat compound is stored by CCLC Set of compounds are solubilized in plates; aliquot in Thurnall tubes Plates are replicated and sent to HTS teams Confirmatory compounds supplied in either soluble or neat format.
5	Production Material Review and Changes
6	Weight Variation in Vial Labels
7	Microplate Seals · DMSO can absorb water from air, evidenced by uneven wells or leakage. · In a recent survey, a set of deep well plates was assessed by visual appearance. Þ Plates dated back to 1996. Þ Sealed with adhesive seals or cap mats Þ Approximately 42% were unchanged. Þ The remaining plates had observable variation in well height and/or overflow, indicating water uptake.
8	Case History - Prolonged Storage in Plates
9	Prolonged Compound Storage in Plates
10	Microplate Seals Experiments
11	Microplate Seals – Water Uptake Experiment Plates were filled with DMSO and weighed within 1 day of preparation, then daily for 12 days thereafter. Calculated the weight difference between day 1 and day 12. Weight increase was < 1% for all seal and plate combinations.
12	Microplate Seals – Biological and Chemical Assessment Approach: Fill shallow v-well plates with DMSO and seal with test seal. Incubated at 22C or 40C for 48 hours, both upright and inverted. Controls: DMSO stored in a glass vial, and V-well plate filled with DMSO but covered with an aluminum plate (not touching DMSO) at the same temps Perform qualitative LC/MS and enzymatic assay.
13	Microplate Seals – Chem/Bio Results
14	Compound Storage in Plates vs. Tubes
15	Process Validations
16	"Objective:" Objective: to determine if significant carryover occurs from filling Thurnall tubes with a Tecan Genesis robot using fixed tips. 1. Dispense DMSO into the odd columns 1 through 9 of a tube rack. 2. Dispense fluorescein even columns 2 through 10 of the same tube rack. 3. Consecutively aspirate liquid from each row of tubes, dispensing the liquid in columns 1 through 10 of a black microwell plate. Wash after each column dispense. Read relative fluorescence of wells in a Tecan SpectraFluor.
17	Relative Fluorescence Units in Test Plate
18	Biological and Chemical Assessment of Thurnall Tubes
19	Process Validations Solvent Stability
20	Solvent Stability Experiment Results
21	Solvent Stability Experiment Results
22	Future Directions