Biopharmaceutical Product Attributes and Biological Consequences Community

Reminder about the following webinar tomorrow! Please register if you haven't.

Please register using the link below for the webinar on September 28th at 12:30 PM EDT presented by Dr. Brian Roberts on the Immunogenicity of Host Cell Impurities.

Event Registration Link:  https://www.pathlms.com/aaps/webinars/37672.

DESCRIPTION

Host cell protein (HCP) impurities are a critical quality attribute (CQA) because they may trigger undesired immune responses with the potential to compromise the safety and efficacy of biologics. The presence of immune responses to Chinese hamster ovary (CHO)-derived HCPs has contributed to the suspension of clinical trials in the past.

HCP impurities may be introduced during process development and manufacturing of biologics and biosimilar products. In recent years, in silico tools and approaches have been developed to quantify the immunogenic risk that these impurities may pose to patients. In silico screening allows for quick assessment and bench-top decision making for process development scientists tracking HCPs present in drug products.

CONTRIBUTORS

• Brian Roberts is the scientific director of the EpiVax Preclinical Immunology program. Dr. Roberts received his Ph.D. in Cell and Molecular Biology from the University of Vermont in 2012. His research in the laboratory of Dr Sally Huber focused on the role of toll-like receptors in sex differences in viral-induced autoimmune myocarditis. Dr. Roberts joined EpiVax in 2015 as a postdoctoral researcher working primarily with the Tregitope team. In 2018 he became manager of the Protein Therapeutics group at EpiVax, and oversees the PANDA(Peptide Abbreviated New Drug Application) program, which provides synthetic generic peptide developers with in silico and in vitro immunogenicity assessments in advance of regulatory filing.

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Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Congratulations to the BPABC Community for hosting two excellent webinars (Combo mAb formulation; Immunogenicity from HCP) within the past week.

Exciting time!

Looking forward to follow-up discussions and input from all of you for what we want to tackle (unmet technical challenges, emerging technologies etc) next in each of these areas. 

To start the list of topics:

1. Combo - How do we simplify the analytical toolbox of combo mAb drug products? For release & stability? For characterization?
2. Combo - How do we further streamline the developability studies of mAb combo?
3. Combo - Is a combo DP feasible combining two protein therapeutics that are far apart in half lives?
4. HCP - What would be a streamlined HCP risk assessment protocol in FIH IND-enabling stage?
5. HCP - Is IND-enabling stage the right time for HCP risk assessment (for both safety and impact on product quality such as polysorbate degradation)?
6. HCP - What is our collective industry/academia experience on success of in-silico assessments of IMG due to HCP (e.g., false positive/negative)?

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Tapan Das, Ph.D., FAAPS
Bristol Myers Squibb


Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer
------------------------------

Original Message:
Sent: 09-27-2023 10:22
From: Srivalli Telikepalli
Subject: Reminder-Webinar Sept 28th at 12:30 PM EDT --- IMMUNOGENICITY ANALYSIS OF HOST CELL PROTEIN (HCP) IMPURITIES

Reminder about the following webinar tomorrow! Please register if you haven't.

Please register using the link below for the webinar on September 28th at 12:30 PM EDT presented by Dr. Brian Roberts on the Immunogenicity of Host Cell Impurities.

Event Registration Link:  https://www.pathlms.com/aaps/webinars/37672.

DESCRIPTION

Host cell protein (HCP) impurities are a critical quality attribute (CQA) because they may trigger undesired immune responses with the potential to compromise the safety and efficacy of biologics. The presence of immune responses to Chinese hamster ovary (CHO)-derived HCPs has contributed to the suspension of clinical trials in the past.

HCP impurities may be introduced during process development and manufacturing of biologics and biosimilar products. In recent years, in silico tools and approaches have been developed to quantify the immunogenic risk that these impurities may pose to patients. In silico screening allows for quick assessment and bench-top decision making for process development scientists tracking HCPs present in drug products.

CONTRIBUTORS

• Brian Roberts is the scientific director of the EpiVax Preclinical Immunology program. Dr. Roberts received his Ph.D. in Cell and Molecular Biology from the University of Vermont in 2012. His research in the laboratory of Dr Sally Huber focused on the role of toll-like receptors in sex differences in viral-induced autoimmune myocarditis. Dr. Roberts joined EpiVax in 2015 as a postdoctoral researcher working primarily with the Tregitope team. In 2018 he became manager of the Protein Therapeutics group at EpiVax, and oversees the PANDA(Peptide Abbreviated New Drug Application) program, which provides synthetic generic peptide developers with in silico and in vitro immunogenicity assessments in advance of regulatory filing.

------------------------------
Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------