Drug Regulators, EMEA, Publish ICH S6(R1), Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.
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Biotechnology-derived pharmaceuticals (biopharmaceuticals) were initially developed in the early 1980s. The first marketing authorisations were granted later in the decade. Several guidelines and points-to-consider documents have been issued by various regulatory agencies regarding safety assessment of these products. Review of such documents, which are available from regulatory authorities, may provide useful background in developing new biopharmaceuticals.
Considerable experience has now been gathered with submission of applications for biopharmaceuticals. Critical review of this experience has been the basis for development of this guidance that is intended to provide general principles for designing scientifically acceptable preclinical safety evaluation programs.
Regulatory standards for biotechnology-derived pharmaceuticals have generally been comparable among the European Union, Japan and United States. All regions have adopted a flexible, case-by-case, science-based approach to preclinical safety evaluation needed to support clinical development and marketing authorisation. In this rapidly evolving scientific area, there is a need for common understanding and continuing dialogue among the regions.
The primary goals of preclinical safety evaluation are: 1) to identify an initial safe dose and subsequent dose escalation schemes in humans; 2) to identify potential target organs for toxicity and for the study of whether such toxicity is reversible; and 3) to identify safety parameters for clinical monitoring. Adherence to the principles presented in this document is intended to improve the quality and consistency of the preclinical safety data supporting the development of biopharmaceuticals.
This guidance is intended primarily to recommend a basic framework for the preclinical safety evaluation of biotechnology-derived pharmaceuticals. It applies to products derived from characterised cells through the use of a variety of expression systems including bacteria, yeast, insect, plant, and mammalian cells. The intended indications may include in vivo diagnostic, therapeutic, or prophylactic uses. The active substances include proteins and peptides, their derivatives and products of which they are components; they could be derived from cell cultures or produced using recombinant DNA technology including production by transgenic plants and animals. Examples include but are not limited to: cytokines, plasminogen activators, recombinant plasma factors, growth factors, fusion proteins, enzymes, receptors, hormones, and monoclonal antibodies.
The principles outlined in this guidance may also be applicable to recombinant DNA protein vaccines, chemically synthesised peptides, plasma derived products, endogenous proteins extracted from human tissue, and oligonucleotide drugs.
This document does not cover antibiotics, allergenic extracts, heparin, vitamins, cellular blood components, conventional bacterial or viral vaccines, DNA vaccines, or cellular and gene therapies.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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