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Immunogenicity Integrated

Who we are

We share a vision of the scientific and regulatory priorities that should be integrated to understand and manage immunogenicity-related risks for successful development of biotherapeutics.

Paul Chamberlain

Paul Chamberlain photo

Paul Chamberlain has been directly involved in the development of biopharmaceutical products since 1983, occupying analytical, bioanalytical, product quality control, monoclonal antibody production and regulatory roles. His interest in immunogenicity risk assessment was triggered by experience gained at Amgen in 1998 with PEG-MGDF and then extended through his role as a Development Programs Director at MDS Pharma Services (2001-2007). Paul started submitting the Immunogenicity Risk Assessment module in Clinical Trial Applications from 2004 and then focused on creating an Integrated Summary of Immunogenicity (ISI) to provide a self-standing section of the CTD format that incorporates the multi-disciplinary information required for a balanced regulatory assessment. His first ISI was submitted in 2009 to support the approval of XIAFLEX™, a clostridial collagenase for treatment of Dupuytren’s contracture. The ISI format was subsequently refined and then adopted into EU (2017) and FDA (2019) guidance.

Paul has worked closely with EU and FDA regulators to understand the priorities for regulatory submissions at different stages of the product life cycle, supporting companies directly at Scientific Advice, pre-CTA/IND, End-of-Phase 2, Pre-MAA/BLA submission, Oral Hearings and FDA Advisory Committee meetings. He has been a Member of the NDA Advisory Board since September 2007, collaborating with regulatory specialists to provide continuous support through all stages of biotherapeutic development and approval for marketing.

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Selected publications...
  • Paul Chamberlain. Presentation of immunogenicity-related information in regulatory dossiers. Regulatory Rapporteur May 2020, Vol. 17, No. 5.
  • Paul Chamberlain. Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers. Bioanalysis 2019, 11 (17), 1581-1592.
  • Chamberlain P. Addressing immunogenicity-related risks in an integrated manner. Regulatory Affairs Pharma, Jan 2011, 10-15.
  • Paul Chamberlain & Bonita Rup. Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates. The AAPS Journal 2020, 22: 65
  • Salmikangas P, Chamberlain P, Silva Lima B & Toivonen M. Immunogenicity of advanced therapy medicinal products: risk factors and mitigation measures. Cell & Gene Therapy Insights 2019; 5(7), 829-857
  • Chamberlain P., Kurki P. (2018) Immunogenicity Assessment of Biosimilars: A Multidisciplinary Perspective. In: Gutka H., Yang H., Kakar S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer
  • Baker, M. P., Jones, T. D. and Chamberlain, P. (2017) Immunogenicity of Biologics, in Protein Therapeutics (eds T. Vaughan, J. Osbourn and B. Jallal), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. doi: 10.1002/9783527699124.ch12

Dr. Arno Kromminga

Dr. Arno Kromminga photo

Arno has been working in the field of regulated bioanalysis since 1996 when he founded a specialised bioanalytical laboratory for the investigation of inflammatory diseases. He was one of the first who identified patients with erythropoietin-induced PRCA in the late 1990’s and since then he has been involved in hundreds of preclinical and clinical studies for the approval of biological medicinal products including a huge variety of innovator and many biosimilar drugs. His major aim is to generate rational assay strategies to obtain solid and clinically meaningful bioanalytical data.

One of his major interests is the interpretation of bioanalytical results to obtain clinically meaningful data. Within this context he has been involved in the approval process of many innovator and biosimilar products including the approval of biosimilar erythropoietin and other biosimilars. Most recently he was involved in the approval studies for Advanced Therapeutic Medicinal Products (ATMP) such as Gene and Cell Therapeutics.

Arno has a PhD in Biochemistry and is a certified Immunologist, is still a faculty member of the University of Kiel (Germany), is author of multiple publications in peer-reviewed journals and books, is a co-founder and board member of the European Immunogenicity Platform (EIP) and active member of other scientific societies including the American Association of Pharmaceutical Scientists (AAPS) and others.

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Selected publications...
  • Gorovits B, Peng K, Kromminga A. Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics. BioDrugs. 2020;34(1):39-54.
  • Homann A, Röckendorf N, Kromminga A, Frey A, Platts-Mills TA, Jappe U. Glycan and Peptide IgE Epitopes of the TNF-alpha Blockers Infliximab and Adalimumab - Precision Diagnostics by Cross-Reactivity Immune Profiling of Patient Sera. Theranostics. 2017;17;7(19):4699-4709.
  • Wadhwa M, Mytych DT, Bird C, Barger T, Dougall T, Han H, Rigsby P, Kromminga A, Thorpe R; Participants of the Study. Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study. J Immunol Methods. 2016;435:32-42
  • Shankar G, Arkin S, Devanarayan V, Kromminga A, Quarmby V, Richards S, Subramanyam M, Swanson S. The quintessence of immunogenicity reporting for biotherapeutics. Nat Biotechnol. 2015;33(4):334-6.

Laura Salazar-Fontana, PhD

Laura Salazar-Fontana, PhD photo

Laura began her regulatory affairs career in 2009 as Immunogenicity Program Coordinator and immunogenicity expert at the FDA, while holding a Chemistry, Manufacturing and Controls (CMC) reviewer position. She evaluated the CMC and immunogenicity of multiple therapeutic proteins INDs, license applications (BLAs) and post-approval supplements. She was responsible for the review and Advisory Committee presentation of the immunogenicity of metreleptin (MYALEPT®), currently approved for the treatment of pediatric and adult lipodystrophy.

After 5 years at the FDA, Laura moved to the private sector to broaden her clinical development knowledge acting as Immunology and Biomarkers expert for Sanofi-Genzyme. In this role, she provided strategic support for analytical bioassay development and immunogenicity risk assessment for Enzyme Replacement Therapies (Avalglucosidase alfa – Pompe’s disease), monoclonal antibodies (Sarilumab – KEVZARA® – Rheumatoid Arthritis, and Alirocumab – PRALUENT® - familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease), and gene therapies (Leber’s Congenital Amaurosis), while developing an expertise in biomarker qualification.

Laura then consolidated her CMC expertise acting as regulatory lead for several US and EU regulatory submissions for Sanofi-Genzyme (PRALUENT®), Fresenius Kabi SwissBiosim (Biosimilars), ZioPharm Oncology (autologous CAR-T cell and gene therapies), PokeACell (autologous tumor infiltrating lymphocytes, TILs) and cBio (cell therapy manufacturing).

Laura holds a PhD in Biochemistry and Molecular Biology and has authored various publications in multiple peer-reviewed journals. She is now based in Lausanne, Switzerland, where she works as independent regulatory consultant.

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Selected publications...
  • Salazar-Fontana LI, Desai DD, Khan TA, et al. Approaches to Mitigate the Unwanted Immunogenicity of Therapeutic Proteins during Drug Development. AAPS Journal 2017; 19(2):377-385
  • Gorovits B, Clements-Egan A, Birchler M, Liang M, Myler H, Peng K, Purushothama S, Rajadhyaksha M, Salazar-Fontana L, Sung C, Xue L. Pre-existing Antibody: Biotherapeutic Modality-Based Review. AAPS Journal, 2016, 18(2): 311-20.
  • Amaravadi L, Song A, Myler H, Thway T, Kirshner S, Devanarayan V, Ni YG, Garofolo F, Birnboeck H, Richards S, Gupta S, Luo L, Kingsley C, Salazar-Fontana L, Fraser S, Gorovits B, et al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 — LBA, biomarkers and immunogenicity). Bioanalysis. 2015 Dec;7(24):3107-24
  • Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, et al. White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 — LBA and immunogenicity), Bioanalysis, 2014; 6 (24): 3355-68