Implementing Process Controls for Cell-Based Assays

  • Wednesday
  • April
  • 28
  • 2021
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes
Webinar Id:
50572

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Overview:

Bioassays are used to demonstrate that a biologic product performs per the stated function and potency.

Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems.

Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts. Monitoring numerous parameters may assist laboratory scientists, laboratory managers, QC and QA personnel to identify and manage trends that could lead to OOS/OOT results.

Monitoring also decreases failure rates by trending parameters that have a direct impact on cell-based methods meeting acceptance criteria. A significant consideration for these methods is setting appropriate system suitability that is consistent with methods that experience higher variability.

Since the number of parameters evaluated is dependent on the cell-type, assay-type, and number of critical component or reagents, this webinar will provide a general overview of the topic as well as specific examples of successful monitoring of cell-based methods leading to a reduction in assay failures. Cell-based methods are known for variability.

Living systems introduce complexity that is not present in simple in vitro methods. Cells respond to the culture medium and controlled environmental conditions at different levels depending on receptor expression, cell passage number, and density in the flask or on the plate.

Responses to small changes in reagents, in analyst technique, and in the environment can have a major impact on cell-based systems. Cells are the primary critical reagent in any cell-based system, whether in production or in a test method.

As in any method, control of the critical reagent is essential for reducing variability. Proper handling of cells and the implementation of controls that are an integral part of the method can reduce variability in cell-based methods.

Control is not just achievable during performance of the method. Process controls must also be considered during cell thaw and seeding, and when seeding of stock cultures used to seed assay plates.

Attendees of this webinar will be introduced to concepts designed to assist with developing cell-based methods focused on a reduction in assay failures. We will address understanding sources of variability and examine the critical characteristics of cell-based assays.

Specifically, the webinar addresses characterization of the cell line, cell maintenance, culturing cell prior to assay set-up as well as for assay set-up. Although the cells are the primary critical reagent, this webinar will also review other critical reagents important in cell culture and cell-based methods. To assist with monitoring we will discuss intermediate performance controls assessed by control charts. Additionally, the webinar will examine and highlight handling of other critical reagents necessary for cell culture.

This includes certification of critical reagents prior to use in method validation or sample analysis. Use of alert and action limits with control charts will also be addressed for effective monitoring.

Finally, writing of the methods and training of analysts to decrease variability will be addressed.

Why you should Attend: Cell-based methods are frequently a necessity for release and testing of biopharmaceutical products.

These methods may also be used for neutralizing antibody assays based on the potency method. Careful consideration must be given to how cells are handled to reduce contributing to the variability that can be observed with cell-based methods.

Unlike other analytical methods, such as ligand binding or chromatography, cells are living components of the assay system and as such require greater control to maintain assay performance within the narrow window of acceptance criteria.

This webinar will address putting in place appropriate controls for cell-based methods. These controls are designed to decrease variability and increase the quality of the methods that are developed and validated for large molecule therapeutics.

Often there is a reluctance to use cell-based methods because of a history of excessive assay failures. Frequently these failures are due to a lack of control of the primary critical reagent, the cells. Understanding how to maintain control in general cell culture prior to initiating the steps of the method is a crucial first phase.

Process controls are important in cell maintenance as well as in the performance of the cell-based method. Cell-based methods can consistently meet acceptance criteria with process controls in place.

Careful planning and consideration of what the controls should be in place for each cell line is an exercise that adds time to the beginning of the study but reduces time required for repeat analysis due to failed assay runs.

Training of analysts to follow process control procedures reduces the need for assay repeats. Attendance at this webinar will provide guidance on how to implement strong process controls for cell-based methods and how to train analysts effectively to utilize those process controls.

Areas Covered in the Session:

  • Brief introduction to cell-based methods
  • Specific areas of variability in cell-based methods
  • Value of control charts
  • Risk associated with lack of monitoring of cells and critical reagents
  • Best practices for data entry on control charts
  • Evaluation of control chart data
  • Reporting structures
  • Inclusion in written test method
  • Handling cells as critical reagents
  • Training of analysts

Who Will Benefit:
  • Laboratory personnel (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Quality assurance personnel (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Quality control personnel (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Laboratory managers (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Manufacturing personnel (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Method development scientists (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Method validation scientists (biopharmaceuticals, pharmaceuticals, dietary supplements)
  • Consultants


Speaker Profile
Gwen Wise-Blackman, Ph.D. has over 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise. Currently she is the owner of Gwen Wise-Blackman Consulting, LLC, a biopharmaceutical consulting firm.

Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Ligand Binding Methods, Technology Transfer, GxP Regulations, Training, Audting, and Quality Assurance.

Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.


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