Host Cell Protein for the Bio/Pharmaceutical Industry Course Outline

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Who Should Attend: This course is designed for scientists, managers and regulatory affairs professionals who are tasked with overseeing the development and validation of host cell protein immunoassays, as well as the overall HCP characterization strategy during development of biotherapeutics. These professionals may reside in the development or commercial release facilities.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime during the 12-session live course! You will receive recordings of past sessions and invitations to join upcoming live sessions. Or sign up to receive links to recordings of any or all sessions from the previous 12-session course.

Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!

Each 60-minute session is just $339 per session or $3732 for all twelve sessions! Great group discounts are available.

FREE WEBINAR! The on-demand recording of Session 1: Introduction to the Evolving Landscape of Host Cell Proteins is available for FREE! Click HERE to watch Session 1 anytime.

Session 1: Introduction to Host Cell Proteins

Introduction to the Evolving Landscape of Host Cell Proteins (FREE!)

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: During production of biotherapeutics, manufacturers are required to control the host cell protein (HCP) impurities during the purification process. HCPs are a very complex process-related impurity that pose unique challenges for accurate monitoring and quantification. This session will serve as an overview of the HCP field where we will discuss what HCPs are, dynamics of HCP expression, and why we need to monitor HCPs during process development and manufacturing.

Session 2: Generation of Reagents to Monitor HCPs

Generating High-Quality HCP Immunoassay Reagents

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: Generating immunoassay reagents to monitor HCPs is the most time-consuming aspect of HCP control strategy. The strategy for reagent generation must be carefully thought out in advance and justified with sound scientific principles to support development of an HCP immunoassay that will be acceptable for use in a clinical and commercial environment. Problems at this stage of assay development can result in delays of a year or more, and therefore, reagent generation is a critical aspect of overall HCP control strategy. This session will cover immunogen generation, immunization strategies, anti-HCP antibody purification and conjugation, as well as reagent storage.

Session 3: Characterization of Reagents for HCP Immunoassays

How to Demonstrate HCP Immunoassay Reagents are Suitable for the Intended Purpose

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: Once immunoassay reagents have been generated, careful characterization is required to ensure the reagents are suitable for use with a given product and process. This includes detailed characterization of HCP protein populations and determination of how well the anti-HCP antibody covers the relevant HCP population. We will discuss different approaches to demonstrate reagent suitability in this session, along with strengths and weaknesses of different methods.

Session 4: HCP Immunoassay Development

Development and Validation of an HCP Immunoassay

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: HCP immunoassays are atypical assays because of the complexity of the analyte.  While some aspects of HCP immunoassay development are very similar to development of any immunoassay, there are unique considerations for HCP immunoassays.  In this session, we will review different formats for HCP immunoassays and assay development and validation.  We will also discuss adapting an HCP ELISA to an automated platform, use of commercial HCP ELISA kits, and the pros and cons of process-specific and platform assays.

Session 5: Orthogonal Methods Overview

Use of Orthogonal Methods for HCP Characterization

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: Although immunoassays remain the gold-standard for monitoring HCPs during bioprocess development, there are inherent shortcomings with this technology. Thorough HCP characterization and assessment of product purity must use orthogonal methods that are not dependent on generation of antibodies. This session will go into detail on how different technologies can be applied to monitor and quantify HCPs in a product, including use of mass spectrometry.

Session 6: Holistic HCP Control Strategy

HCP Control Strategy at All Development Phases

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: Many tools and technologies are available to characterize and quantify HCPs. However, it is often not necessary to deploy the entire HCP toolkit at all phases of development. Phase-specific optimization of HCP strategy can help with investing resources when they are needed to ensure assay suitability and patient safety. This session will review phase appropriate control and characterization of products, including setting limits, HCP characterization, and assay/reagent characterization.

Session 7: USP <1132>

Overview of USP <1132>

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: In 2015, USP published the General Information Chapter <1132>: Residual Host Cell Protein Measurement in Biopharmaceuticals. This document is an overview of terminology, methods, best practices, and supporting technologies for HCP analysis. It is the culmination of experience from leaders in the field from over 20 years of HCP monitoring, quantification, and characterization. While this chapter is not official guidance, it is important for those who work on HCPs to understand the full content.

Session 8: Regulatory Requirements for HCPs

Regulatory Expectations for HCP Analysis

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: Unlike other process-related impurities, there is little specific official guidance on HCP control in biotherapeutics. In this 60-minute session, we will review all guidances that are relevant to HCP monitoring and control, as well as the recently published chapter from the European Pharmacopeia (EP). We will also discuss differences between the USP and EP guidance, and overall expectations from health authorities with respect to HCPs.

Session 9: HCP Characterization During Process Development

Characterization of HCPs During Process Development

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: High-throughput purification and cell culture process development has emerged with improvements with technology and automation. Likewise, improved technologies have enabled characterization of HCPs to keep up with the new pace of process development. In this session, we will review how to effectively monitor HCPs during process development to speed your overall development time as well as result in enhanced HCP clearance from products.

Session 10: Risk Assessment for HCPs

How to Assess Risk of HCPs in your Product

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: As analytical technologies improve, the biotechnology industry will be faced with the fact that HCPs have likely always been in biotherapeutics and likely always will be in biotherapeutics. Risk assessments are very important tools to guide limits for HCPs in general and for specific HCPs, when necessary. We will discuss important considerations for risk assessments for a given product or for a given HCP, and how these risk assessments can be implemented in a phase-appropriate way.

Session 11: Clinical Case Studies

Review of Experiences with Patient Exposure to HCPs

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: Publicly available examples of patient exposure to HCPs are few and far between. However, the case-studies that exist are extremely informative about the potential consequences of HCPs to patients and manufacturers, and can help inform internal decision-making processes about HCP characterization and limit setting. This final session will review case studies of patient exposure to HCPs that have been published in the literature.

Session 12: Future Trends

How Future Trends in Products and Technologies will Impact HCP Analysis and Characterization

  • Instructor: Dr. Denise Krawitz
  • Format: On-demand recording available now.
  • Content: The biotechnology industry has a relatively mature monoclonal antibody platform to express products in CHO or E. coli cells. However, as we look towards the future, biosimilars, gene therapies, vaccines, non-platform molecules, and novel expression systems are becoming more prevalent. How can we apply our current knowledge to these unique systems and effectively monitor and control HCPs? What new technologies will become important for HCPs analysis? How does HCP analysis fit into commercialization of biosimilars?

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.