Novo Nordisk will no longer use live animals to test production batches of its biological products, the Danish company has announced.

Animals were last used for virus control of Novo Nordisk’s haemophilia product recombinant Factor VII (NovoSeven) on 28 November, marking the end of animal testing for quality control of the company’s biological production batches.

Instead, it will use cells from hamsters and other animals to test its production batches for biological activity. These methods produce a narrower range of results with more precision and reliability, Novo Nordisk says. The transition has involved amending thousands of registration dossiers to satisfy health authorities worldwide, it points out.

The relatively large numbers of animals required in the development, manufacture and quality control of biologicals, as well as the nature of some of these tests, have made them a focus of efforts to implement the 3Rs (Reduce, Refine, Replace) principles in the pharmaceutical industry.

Batch to batch

The use of live organisms in the production of biologics raises concerns about batch-to-batch variability and the potential for contamination. As a result, potency and safety testing are typically required for each individual batch of a biological to maintain quality control. This often involves animal tests rather the in vitro assays used for quality control of small-molecule drugs.

The number of animals needed for biological control tests, as well as the types of tests required, are determined by the regulatory requirements of the countries in which Novo Nordisk sells its products, the company notes. These requirements may vary from one country to another, leading in some instances to duplication of tests.

Task force

According to Novo Nordisk, its own employees have been questioning the validity of animal-based procedures for quality control of biologicals since the 1980s.

The company set up a task force more than 10 years ago with the goal of eliminating all redundant product-control tests in living animals or replacing them with other test methods that would guarantee the same product safety.

Over the years, the number of animals used at Novo Nordisk for this purpose – including mice, rats, guinea pigs, hamsters and rabbits – has gradually fallen from more than 13,000 a year in the 1990s to 2,078 in 2000 and 772 in 2010, the company says. 

“Today’s achievement is a milestone in our ongoing commitment to animal ethics in Novo Nordisk,” commented executive vice president and chief science officer Mads Krogsgaard Thomsen  

“We have been working for more than a decade, in close collaboration with regulatory authorities around the world, to eliminate obsolete tests or develop and certify new laboratory assays that can be used instead of animals to evaluate the consistent quality of our marketed products.”

The total number of animals used in testing at Novo Nordisk was 62,152 in 2010. The company reduced this figure by almost 70% in the 1990s and since then has been able to keep the numbers at roughly the same level despite increasing research activities year on year, it points out.