Formulation Development of Antibodies Using Robotic System and High-Throughput Laboratory (HTL)

The goal of protein formulation development is to identify optimal conditions for long-term storage. Certain commercial conditions (e.g., high protein concentration or turbid adjuvanted samples) impart additional challenges to biophysical characterization. Formulation screening studies for such conditions are usually performed using a simplified format in which the target protein is studied at a low concentration in a clear solution. The failure of study conditions to model the actual formulation environment may cause a loss of ability to identify the optimal condition for target proteins in their final commercial formulations. In this study, we utilized a steady-state/lifetime fluorescence-based, high-throughput platform to develop a general workflow for direct formulation optimization under analytically challenging but commercially relevant conditions. A high-concentration monoclonal antibody (mAb) and an Alhydrogel-adjuvanted antigen were investigated. A large discrepancy in screening results was observed for both proteins under these two different conditions (simplified and commercially relevant). This study demonstrates the feasibility of using a steady-state/lifetime fluorescence plate reader for direct optimization of challenging formulation conditions and highlights the importance of performing formulation optimization under commercially relevant conditions.

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Identification and characterization of iPS clones via automated live-imaging and in-process analysis for quality control using high throughput robotic system

Cytotherapy ◽

10.1016/j.jcyt.2019.03.523 ◽

2019 ◽

Vol 21 (5) ◽

pp. S91

Author(s):

V.R. Mantripragada ◽

V. Luangphakdy ◽

B. Handerhan ◽

B. Hittle ◽

K. Powell ◽

...

Keyword(s):

Quality Control ◽

High Throughput ◽

Process Analysis ◽

Live Imaging ◽

Robotic System ◽

Identification And Characterization

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An integrated robotic system for high-throughput process development of cell and virus culture conditions: Application to biosafety level 2 live virus vaccines

Engineering in Life Sciences ◽

10.1002/elsc.201400245 ◽

2015 ◽

Vol 16 (2) ◽

pp. 202-209 ◽

Cited By ~ 4

Author(s):

Christopher Daniels ◽

Jason Rodriguez ◽

Esther Lim ◽

Marc Wenger

Keyword(s):

High Throughput ◽

Process Development ◽

Culture Conditions ◽

Robotic System ◽

Live Virus ◽

Virus Culture ◽

Level 2 ◽

Biosafety Level ◽

Biosafety Level 2

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Stacker Modules Used in a High-Capacity Robotics System for High Throughput Screening Compound Replication

CrossRef Listing of Deleted DOIs ◽

10.1177/108705719900400612 ◽

1999 ◽

Vol 4 (6) ◽

pp. 373-379 ◽

Cited By ~ 2

Author(s):

Mark Beggs ◽

Herman Blok ◽

Jan Mertens

Keyword(s):

High Throughput ◽

High Throughput Screening ◽

High Capacity ◽

Robotic System ◽

Throughput Capacity ◽

Process Automation ◽

Technology Process ◽

Human Operators ◽

Automation Project ◽

Logistics Control

High throughput screening is now established as a key component of the pharmaceutical lead identification process in many pharmaceutical companies. Over recent years, thanks to advances in assay technology, process automation, and logistics control, the throughput capacity of HTS groups has increased significantly. It is now entirely possible to screen corporate compound collections against an individual pharmacological target within a timescale of several weeks. Despite these improvements, many HTS groups find that their capacity is limited by the rate at which they can provide test compounds in a "screen-ready" format. This limitation is usually imposed by the capacity and productivity of the single-armed robotic systems utilized. We have recently constructed a robotic system aimed at overcoming this particular problem. This system uses purpose-built microplate stacker units that provide high-capacity microplate storage and, importantly, provide an easy and fast interface between the robotic system and the human operators. This paper describes this automation project and the benefits that have resulted from its deployment.

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