Porcine Trypsin in the Manufacture of Biological Medicinal Products. Risks and Safety Requirements

Abstract

Trypsin is a reagent widely used in the manufacture of biological medicinal products (BMPs). Until recently, pancreata of cattle, pigs and poultry were the main sources of trypsin preparations. The discovery of the disease called «transmissive spongiform encephalopathy» or «cow rabies» (TSE) in cattle in the late 1980s showed a clear need for limiting the use of this source. Given the potential risk of using trypsin obtained from cattle, porcine trypsin became more commonly used in the production of biological medicinal products. Enzymes obtained from raw materials of animal origin can be contaminated with circoviruses, parvo- and pestiviruses, and mycoplasmas that are common to pigs. Due to high resistance to physical and chemical treatment, these contaminants pose a potential risk to recipients of vaccines, as well as to other biological medicinal products. Prevention of contamination requires measures aimed at detection, reduction and inactivation of foreign agents, both in raw materials and during BMP production. The article considers the most common types of porcine trypsin contamination, methods of its detection, reduction and elimination. The article also contains information on the Russian and international requirements for the quality and safety of porcine trypsin used in the production of biological medicinal products.