Implementing a Compliant Stability Program for Biologics

This webinar will address developing and validating methods suitable for use as stability-indicating, This webinar addresses issues present when designing and implementing a stability program for large molecule therapeutics.

Gwendolyn Wise-Blackman
Wednesday, June 5, 2019
10:00 AM PDT | 01:00 PM EDT
90 Minutes

More Trainings by this Expert   Product Id : 502538

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Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency.

Also, contamination during processing is a pathway for loss of sterility with a detrimental impact on shelf life. Stability programs for large molecule therapeutics require careful consideration of the factors that can lead to a negative impact on identity, potency, and sterility.

Data supporting expiry dating controls how long these products should remain on the shelf and available to the patient.

Data also supports the appropriate storage conditions required to maintain stability during storage after production and transport to patient sites.

To not develop and validate appropriate stability-indicating methods puts product stability at risk and is not compliant. When product stability is at risk, therapeutic benefit to the public also at risk. To successfully select stability-indicating methods requires knowledge of the possible degradation pathways for biologics that have an impact on critical quality attributes (CQA).

For biologics, prior identification and assessment of CQA is an important component of determining methods suitable for determining stability. Not giving careful thought to the CQA important for biologic potency and identity has the potential to introduce a fatal flaw to a stability program.

An important requirement for compliant stability programs is understanding regulatory expectations. Guidance documents are available that provide an overview of expectations. The minimum requirement is to perform testing per those guidance documents. However, additional testing may be necessary depending on the susceptible nature of the biologic to conditions found during storage and preparation for delivery to the patient.

In some instances, early analysis of the biologic may suggest significant problems with stability. Modifications to the structure may improve the stability. Early assessment of potential problems with stability may allow changes to be made in early production runs that will improve stability in the final processing.

This webinar will address understanding pathways that are known to contribute to loss of stability in biologics.

In addition to understanding what can contribute to loss of potency, this webinar will address selecting appropriate test conditions to confirm stability of the biologic that are compliant with regulatory guidance documents. Test conditions used to assess stability may need to include additional time points and additional stressed conditions to fully determine the stability of a biologic.

Data observed during early runs will help determine the additional testing that may be required to confirm a biologic is stable in the conditions in which it will be stored prior to administration to a patient.

The methods that are selected for each test condition must be developed with validation in mind. These methods should be rugged and specific.

Differences in responses between the stable biologic and partially degraded drug should be significant in the validated method. Changes in the biologic that are observed during stability testing should be documented as having an impact on stability or should be considered a minor change with no impact.

All data is reported and the relevance on the impact to stability and expiry dating should be noted. This webinar will address developing and validating methods suitable for use as stability-indicating.

Why should you Attend: All drug substances and drug products require expiration dating. Data used to support and set expiry and shelf life must be collected and analyzed using guidelines set by regulatory agencies.

Processes and considerations for small molecules are inadequate for large molecule therapeutics.The complexity of large molecule therapeutics allows for a greater potential to lose potency through multiple pathways.

This webinar addresses issues present when designing and implementing a stability program for large molecule therapeutics.

Data from high quality methods that detect changes to the drug molecule are necessary to establish stability for biologic drugs. In addition to a stability-indicating method that measures identity, assessing potency is necessary. Since many biologic drugs are produced and packaged under sterile conditions, purity of the drug during stability testing is also important. Not properly assessing potency, identity, or purity at multiple timepoints and storage conditions puts patients administered the drug at risk for adverse events or declining therapeutic effect.

To collect data that supports expiry dating, the drug substance and the drug product must be thoroughly tested in stability indicating methods. Understanding the importance of these methods and the analysis and interpretation of the data is necessary for personnel involved in product development, product testing, and product release.

Degradation pathways may be accelerated with changes in the environment in which the biologic is administered or stored. Differences in climates across the globe has an impact on stability. Stability programs for biologics must consider the final environment of the drug prior to administration to the patient.

Areas Covered in the Session:

  • Understanding the difference between stability for small molecules and large molecules or complex drug products
  • Regulatory expectations
  • Special considerations for biologic stability
  • Designing and validating stability indicating methods
  • Implementing a stability program
  • Degradation pathways
  • Areas of concern for loss of stability
  • Setting strategy to control stability
  • Testing CQAs
  • Stability Indicating Methods
  • Test conditions, including stress conditions
  • Data requirements
  • Considerations for expiry dating

Who Will Benefit:
  • Pharmaceutical Regulatory Affairs
  • Biopharmaceutical Regulatory Affairs
  • Consultants
  • Laboratory Scientists
  • Laboratory Managers
  • Quality Assurance Specialists
  • Quality Control Specialists

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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