Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

Why Should You Attend:

cGMP drug products relies on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product in valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.

Attendees will be able to relate to the steps that are involved in the performance of the different types of endotoxin test, when to use what method, the sensitivity of each chosen method. The attendee will also be able to understand the advantages and disadvantages of each method and how to identify, investigate and resolve false positive or negative results. Attendees will also be able to understand how the production and process controls of a manufacturing facility affect the product endotoxin levels.

Areas Covered in the Webinar:

This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries that manufactures cGMP product requiring bacterial endotoxin release assay.

1. Introduction to current USP <85> Bacterial Endotoxin Test
• Details of the Regulation and Requirements
2. Types of Bacterial Endotoxin Test Methodologies
• Basics of the Rabbit Pyrogen Test
• Basics of the Gel Clot Methodology
• Basics of the Chromogenic Methodology
• Basics of the Turbidimetric Methodology
3. Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
• Advantages and Disadvantages of Each Methodology
• Rabbit Pyrogen Test
• Gel Clot Methodology
• Chromogenic Methodology
• Turbidimetric Methodology
• How to determine the appropriate method based on product types.
• Sensitivity of each methodology
• Appropriateness of the method of choice
• Suitability of Methodology for Product Testing
4. Initiating a Bacterial Endotoxin Test-Initial Considerations
• Initial Product Evaluation
• Materials and Regents Evaluation
• Evaluation of Acceptable Endotoxin Concentration Limits based on Product Type
5. LAL Testing Materials and Reagent Qualification
• Receipt, Handling and Storage of Materials and Reagents
• Qualification of Materials and Reagents
6. Products Receipt, Handling and Storage
• Refrigeration versus Freezing
• Acceptable Hold Time
• Hold Time Studies
7. Product Processing
• Differences Between Processing Medical Device versus Liquid Formulations
8. Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
• Differentiating between False Positives and False Negatives
• Impact of Materials to Create False Results
• Vendor Changes to Materials and Impact to Test Results
• Impact Arising From Product Containers (Impact from Leacheables)
• Investigation an LAL OOS
• Retest Considerations and Guidelines
• Impact to Manufactured Product
9. Relationship of Endotoxin Test (LAL) with other Production and Process Controls
• Impact from Lack of Control of Product Bioburden
• Impact from Lack of Control from the Cleanroom Environment
• Impact from Personnel
• Impact from Inadequate Disinfection Practices
• Impact from Inadequate Sterilization or Depyrogenation Process

Who Will Benefit:

This topic applies to personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries. The employees who will benefit most include:

• Quality Control Analyst and Management
• Senior Management
• Manufacturing Associates and Management
• Quality Assurance Analyst and Management

Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

Charity Ogunsanya (CEO/Founder, Pharmabiodevice Consulting LLC) has over 23 years of extensive experience within the pharmaceutical, biotechnology, biologics, cell-therapy, diagnostics, research and development, radio-pharmaceutical, contract manufacturing organizations (CMOs) and medical device companies.

Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the quality and compliance division in major Fortune 100 companies as a subject matter expert (SME), site manager, multi-site manager and as a director.

She has been a sought after expert to assume key roles specifically related to remediation and deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and difficult regulatory bodies inspectional findings. She has also been a sought after as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to quality systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful national and international regulatory bodies’ inspections, re-inspection and new product approvals.

Her technical expertise are not limited to the interpretation, administration and set up of quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations. She is currently the CEO of Pharmabiodevice Consulting LLC targeted towards quality and compliance related remediation, enhancements and consultant services for various companies within the industry. She is a high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.

She has a Bachelor of Science degree in microbiology from the University of Benin-Nigeria and she is currently attaining her masters in biotechnology (biodefense concentration) at the Johns Hopkins University Advanced Academic Program.

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