A survey of the alternatives to animal testing used by pharmaceutical industry in Taiwan

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(The photo provided by Taiwan Agricultural Science and Technology Resources Logistics Management Association)

In order to find out how Taiwan pharmaceutical industry evaluate to make use of the alternatives to animal testing, we interviewed 15 biologics manufactures and pharmaceutical companies in this study. In 2020, the total numbers of experimental animals used by these surveyed companies was 18,971 rodents, followed by 256 rabbits and 30 primates (Table 1). The use of laboratory animals is expected to increase by 100-200% in 2021 as the heavy demand on biologics and vaccines has been driven by the COVID-19 pandemic. The survey on the purpose of using animal testing revealed that "non-clinical safety testing" ranked the first (67%), then followed by "drug discovery" (60%) and "inspection of the biologics products" (53%).

Table 1. Species and number of experimental animals used by the surveyed companies in 2020 (N=15).

The test methods by which the surveyed companies used for pyrogen testing were Limulus Amebocyte Lysate (LAL) for 75%, rabbit pyrogen testing (RPT) for 38% and Monocyte Activation Test (MAT) in 25% (Figure 1). The test methods they used are mainly based on the products regulation of target countries, and then on the characteristics of the drugs. Because the interviewed companies are not familiar with the MAT assay and the MAT assay is not widely accepted by the regulatory agencies in other countries, the MAT is not commonly used in Taiwan pharmaceutical companies.

Figure 1. Percentage of the pyrogen test methods used by surveyed companies (N=8)

The factors that influenced companies’ consideration for using alternatives to animal testing are listed as follows, "the adoption of alternatives to animal testing by the regulations for product inspection" comes first, followed by "the cost of the alternatives to animal testing", "the animal welfare issues", and then "the human resource with relevant technologies" (Figure 2).

Figure 2. The factors that influenced the surveyed companies’ consideration for using alternatives to animal testing. (N=15)

Forty percent of the surveyed companies estimated that the numbers of laboratory animals used will be reduced by 1% to 10% in 2021. That is resulted from some animal testing has been replaced by alternatives, and also the animal reduction plan has been achieved by experimental design, and so on; The other 40% of the surveyed companies stated that the number will remain the same; The rest 20% of the surveyed companies estimated the number of experimental animals used will be increased by 5% or even 100% to 221.8%. The increasing number is because of the investment in COVID-19 vaccine development and manufacturing processes, and also the expansion of new production lines, and the verification requirements of personnel and products (Figure 3).

Figure 3. The prediction for the change of laboratory animal usage in 2021 by the surveyed companies. (N=15)

The companies showed less incentive to use alternatives to animal testing until that have been adopted in the regulations of product registration by the regulatory authority. The measures to promote the regulatory authorities accelerating the implementation of 3R policy are such as "preferential adoption of data by alternative test methods for product inspection and registration", "promotion of new drug development with the concept of partial replacement to animal testing", "provision of training program and platform for alternatives technical personnel", "concession on rental of hardware for alternatives technologies", and "establishment of 3R certification system for the laboratories of animal testing".

The research report is presented by Taiwan Agricultural Science and Technology Resources Logistics Management Association, which is supported by the Council of Agriculture (CoA), Executive Yuan, Taiwan. And we also acknowledge to the cooperation of these surveyed companies from pharmaceutical industry and biologics manufacturer in Taiwan.

The original news report (written in Mandarin):

Edited by: Hsien-Jen Cheng, Ph.D. and Ping-Jung Yi.
Revised by: Pinpin Lin, Ph.D., DABT