Guideline on safety evaluation of cell-based medicinal products for animal use

With the increased use of cell therapy in the veterinary sector, there is a growing demand for the development of cell-based medicinal products and the determination of their safety. Currently, the Korean Animal and Plant Quarantine Agency has established a guideline for evaluating the safety of cell-based medicinal products for animal use. The guideline includes items related to definition, classification, management, manufacturing procedure and quality control (standard and test method), stability testing, toxicity testing, pharmacological testing, and performance of clinical trials. In addition, testing protocols related to safety assessment of animal cell-based products such as chromosome karyotyping, tumorigenicity testing, confirmatory testing of biodistribution and kinetics, and target animal safety testing are described in detail. Moreover, because cell-based medicinal products are novel therapies, deviations from traditional designs may be justified in order to obtain relevant safety information on the treatment. Additionally, this guideline can be amended on the basis of new scientific findings.

Comparative Analysis of In-use Period after First Opening or Reconstitution of European Union Imported Sterile Products and Domestic Sterile Products in Our Hospital / 中国药师

Objective: To provide reference and suggestions for improving the in-use period information of sterile products after first opening or reconstitution in China. Methods: The package inserts of sterile products in our hospital were investigated. The sterile products needed to be reconstituted before use and with multiple-dose package were selected. The in-use period information of European imported sterile products and domestic sterile products were comparatively analyzed. Results: The presentation rate of in-use period in the package inserts of domestic sterile products was 32. 25% , which was less than 55. 56% of the other imported sterile products, and significantly less than 93. 55% of European imported sterile products. Conclusion: The relevant content of in-use period of sterile products after first opening or reconstitution is supplemented relatively late in China's stability testing guidance for drug substances and products, moreover, the specific technical proposals are absent. It is suggested that the drug administrative department and its techni-cal supportive agencies should improve the relevant guidance and guide pharmaceutical research enterprises and manufacturing enterpri-ses to carry out in-use stability studies, furthermore, gradually improve the relevant in-use period information in package inserts.

Concentration by membrane separation processes of a medicinal product obtained from pineapple pulp

The concentration of pineapple juice is needed to retain the bromelain activity and to standardize the composition and proteolytic activity. Thus, this work aimed to obtain a pure bromelain extract from the Ananas comosus L. Merril juice by membrane separation process. A 2² experimental planning was used to study the influence of pH and transmembrane pressure on the activity recovery by micro-filtration using a plain membrane. In second step, this enzyme was purified by the ultra-filtration using a 10 kDa millipore kit. The best operation condition to bromelain concentration using the plain membrane was at pH 7.5 and transmembrane pressure of 0.05 bar, while 85 percent of bromelain activity was recovered. Ultra-filtration retained 100 percent of proteolytic activity and concentrated in 10 fold the bromelain extract. SDS-PAGE electrophoresis showed that the ultra-filtrated had high purity and the bromelain from A. comosus pulp had a molecular weight of 24.5 kDa.

A concentração do suco de abacaxi é necessária para manter a atividade da bromelina e padronizar a composição e atividade proteolítica. Assim, este trabalho objetivou a obter um extrato de bromelina pura do suco do Ananas comosus L. Merril por processos de separação por membranas. Um planejamento experimental do tipo 2² foi feito para estudar a influência do pH a da pressão transmembranar sobre a recuperação da atividade por micro-filtração usando uma membrana plana. Em uma segunda etapa, purificou-se a enzima alvo por ultra-filtração usando um "kit millipore" de 10 kDa. A melhor condição para a concentração da bromelina foi a pH 7,5 e pressão transmembranar de 0,05 bar, onde 85 por cento da atividade da bromelina foi recuperado. A ultra-filtração manteve 100 por cento da atividade proteolítica e concentrou em 10 vezes o extrato de bromelina. A eletroforese via SDS-PAGE mostrou que o ultra-filtrado teve alta pureza e a bromelina da polpa do Ananas comosus tem um peso molecular de 24.5 kDa.