About PER.C6® technology

PER.C6® technology is a comprehensive package of tools designed to facilitate the large-scale production of safe and affordable biopharmaceutical products, such as vaccines, monoclonal antibodies and gene therapy products.

 

This technology offers major advantages over other platforms used for manufacturing biological products and is uniquely positioned to meet the key challenges in the industry. These include the need to produce larger volumes of product more quickly and cost-effectively, while meeting increasingly stringent safety requirements.

An innovative cell line

The heart of PER.C6® technology is the PER.C6® human cell line. This is a continuously dividing set of cells derived from a single human cell, immortalized using recombinant DNA technology. Like other continuous cell lines, PER.C6® cells can replicate indefinitely—but that is where the comparison ends.

Higher yields at lower cost

One of the great advantages of PER.C6® cells is that they grow to much higher density than other continuous cell lines. This is due to inherent characteristics of the PER.C6® cells themselves, which are further enhanced by the intensified manufacturing process and special growth media developed as part of the PER.C6® technology package.

 

The ability of PER.C6® cells to grow to exceptionally high densities means that much more biological product can be harvested from much smaller bioreactors. For example, PER.C6® cells infected with virus for manufacturing purposes produce at least 10 times more virus per milliliter than any other cell line does. The same yield can therefore be obtained from a 500-liter bioreactor using PER.C6® as a 5000-liter or larger bioreactor using another cell line. This translates into significant savings in capital expenditure and production costs, as well as shorter production times.

Outstanding safety record

The PER.C6® cell line has an unrivalled safety record, built up over a decade of preclinical and clinical studies. These data, together with a full description of the origin and development of the PER.C6® cell line, are included in an extensive Cell Substrate Biologics Master File lodged with the FDA, the US regulatory agency. The human origin of the PER.C6® continuous cell line offers a further safety assurance, compared with animal-based biopharmaceutical production platforms.

A total solution

There is more to PER.C6® technology than an innovative human cell line. What sets PER.C6® technology apart from other biopharmaceutical production platforms is the entire toolkit developed over the past decade, which includes the PER.C6® cells, the regulatory data, the many clinical trials of PER.C6®-based products, the proprietary culture media, the intensified manufacturing process and the huge amount of know-how that has been generated. This combination means that PER.C6® technology can be considered a total solution for biopharmaceutical manufacturers.

 

PER.C6® technology is an ideal companion for other innovative Crucell technologies, such as the virosome (a vaccine design technology combining high efficacy with low side effects) and AdVac® technology (which focuses on the development of novel adenovirus vectors and is used with PER.C6® to develop recombinant vaccines).

The history of PER.C6® technology

The PER.C6® human cell line is the cornerstone on which Crucell was built. It was  originally developed for making antibodies against cancer and for gene therapy, but around 2002 researchers in the company discovered that a wide range of viruses also grow very well on PER.C6®. This meant that PER.C6® could be developed as a platform for producing the new viral vaccines the world needs—classical as well as adenovirus-based vaccines.