From 2018 to 2021, 895 research institutions in Brazil registered at the National Council for the Control of Animal Experiments, Concea, were authorized to use more than 16 million animals in experiments. This historical series is published for the first time and the data were obtained through a Brazilian law known as the Information Access Law (LAI). The purpose of this text is to review the literature and problematize access to data on the use of animals as a fundamental condition to change the paradigm in experimental science in the construction of a world with fewer deaths. The article reconstructs the cultural bases and scientific practices that influenced ethics about animals, especially their use in laboratories. At the same time, it indicates that, since antiquity, there were already thoughts that animals should be treated with dignity and humanity. The text presents the emergence of alternative methods in the late 1950s and questions the role of ethics committees in reducing the use of animals in laboratories.

De 2018 a 2021, 895 instituições de pesquisas no Brasil cadastradas no Conselho Nacional de Controle de Experimentação Animal, o Concea, tiveram a autorização para utilizar mais de 16 milhões de animais em experimentos. A série histórica está sendo publicada com ineditismo por este artigo e os dados foram conseguidos por meio da Lei de Acesso à Informação, a LAI. A proposta desse texto é problematizar o acesso aos dados do uso de animais como condição fundamental para mudar o paradigma na ciência experimental na construção de um mundo com menos mortes. O artigo reconstitui, historicamente, as bases culturais e práticas científicas que influenciaram a ética em relação aos animais, em especial ao uso desses em laboratórios. Ao mesmo tempo, indica que, desde a antiguidade, já existiam pensamentos de que os animais deveriam ser tratados com dignidade e humanidade. O texto apresenta a emergência dos métodos alternativos ao uso de animais a partir do final dos anos 50 e questiona o papel dos comitês de ética para a diminuição do uso de cobaias nos laboratórios.

Abstract The treatment with hyperimmune sera constitute the only specific and effective therapy available against snakebite envenomation, most common in developing countries. Serum quality is an important factor on patient recovery time and in the incidence of death and permanent disability. To date, most sera consist of pepsin digested IgG antibodies harvested from hyperimmune animals. The use of animal derived enzymes, such as pepsin, to digest IgG, constitute a source of adventitious agents and contaminants, such as porcine circovirus. The present study aims to evaluate the use of the plant derived enzymes bromelain and ficin, as an alternative to pepsin. To this purpose, horse serum immunized against Bothrops venoms was purified with caprylic acid and digested with bromelain or ficin. SDS-PAGE results evidence the formation of F(ab)’2 fragments and suggest that a digestion time superior to 8 hours may be required to completely digest the antibodies with bromelain or ficin. F(ab)’2 fragments obtained by digestion with either bromelain or ficin digestion preserved the ability to recognize Bothrops sp. venom in western blotting assays. Therefore, both enzymes are suitable for use in large-scale production, minimizing contamination risks and increasing safety and efficiency of serotherapy treatments.

The use of serum containing polyclonal antibodies from animals immunized with toxins marked the beginning of the application of antibody-based therapy in late nineteenth century. Advances in basic research led to the development of the hybridoma technology in 1975. Eleven years later, the first therapeutic monoclonal antibody (mAb) was approved, and since then, driven by technological advances, the development of mAbs has played a prominent role in the pharmaceutical industry. In this review, we present the developments to circumvent problems of safety and efficacy arising from the murine origin of the first mAbs and generate structures more similar to human antibodies. As of October 2017, there are 61 mAbs and 11 Fc-fusion proteins in clinical use. An overview of all mAbs currently approved is provided, showing the development of sophisticated mAbs formats that were engineered based on the challenges posed by therapeutic indications, including antibody-drug conjugates (ADC) and glycoengineered mAbs. In the field of immunotherapy, the use of immunomodulators, bispecific mAbs and CAR-T cells are highlighted. As an example of promising therapy to treat infectious diseases, we discuss the generation of neutralizing monoclonal-oligoclonal antibodies obtained from human B cells. Scientific and technological advances represent mAbs successful translation to the clinic.

ABSTRACT The use of a commercial kit for the monocyte-activation test (MAT) was evaluated for assessing pyrogenic contamination of hyperimmune sera . Three batches of sera, two pyrogen free and one pyrogenic, were tested. Endotoxin spike recover indicated that sample dilutions from 1/2 to 1/10 are suitable. Kit transport and storage conditions were also evaluated, proving that an adequate cold chain must be assured to achieve good results. Furthermore, the commercial MAT kit seemed suitable to replace the rabbit pyrogen test (RPT) for pyrogen testing of hyperimmune sera, although further tests are needed to a full validation.

The aim of this study was to compare the PSPT standardized in-house as an alternative to MPT for potency assays of pertussis component. Statistical analyses have showed similar pertussis potency values when PSPT was compared to MPT. Significant correlation between the potency results obtained by in vivo and in vitro assays was also been observed. Results by PSPT have demonstrated reproducibility and accuracy for potency pertussis control and this approach has been considered promising for use at least during the steps of production.