title: Non-clinical Safety Evaluation of Biotherapeutics - Challenges, Opportunities and new Insights.
abstract: New challenges and opportunities in nonclinical safety testing of biotherapeutics were presented and discussed at the 5th European BioSafe Annual General Membership meeting in November 2015 in Ludwigshafen. This article summarizes the presentations and discussions from both the main and the breakout sessions. The following topics were covered in six main sessions: The following questions were discussed across 4 breakout sessions (i-iv) and a case-study based general discussion (v).
authors: AbbVie GmbH, Ludwigshafen, Germany. Electronic address: guenter.blaich@abbvie.com.
authors: Guenter
authors: G
authors: Blaich
authors: Bayer Pharma AG, Berlin, Germany.
authors: Andreas
authors: A
authors: Baumann
authors: Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland.
authors: Sven
authors: S
authors: Kronenberg
authors: MedImmune, Cambridge, UK.
authors: Lolke
authors: L
authors: de Haan
authors: Novartis Pharma, Basel, Switzerland.
authors: Peter
authors: P
authors: Ulrich
authors: Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland.
authors: Wolfgang F
authors: WF
authors: Richter
authors: UCB Celltech, Slough, UK.
authors: Jay
authors: J
authors: Tibbitts
authors: ADC Therapeutics, UK.
authors: Simon
authors: S
authors: Chivers
authors: AbbVie BioResearch, Worcester, USA.
authors: Edit
authors: E
authors: Tarcsa
authors: AbbVie Inc., North Chicago, USA.
authors: Robert
authors: R
authors: Caldwell
authors: Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland.
authors: Flavio
authors: F
authors: Crameri
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods; D000818:Animals; D030801:Animals, Genetically Modified; D000906:Antibodies / Q000009:adverse effects* / Q000737:chemistry / Q000276:immunology; D001688:Biological Products / Q000009:adverse effects* / Q000737:chemistry / Q000276:immunology / Q000493:pharmacokinetics; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects* / Q000379:methods; D004339:Drug Compounding; D015316:Genetic Therapy / Q000009:adverse effects* / Q000379:methods; D006801:Humans; D023421:Models, Animal; D008962:Models, Theoretical; D061214:Patient Safety; D011092:Polyethylene Glycols / Q000009:adverse effects; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D000906:Antibodies; D001688:Biological Products; D011092:Polyethylene Glycols
keywords: Antibody-drug conjugate; Biotherapeutics; Cross-reactive species; Gene and cell therapy; Immunogenicity; Nonclinical safety; PEGylated biologics; Pharmacokinetics