Scope and technology principle

The manufacturing of biopharmaceuticals is subject to many changes, such as rising volume demands and more stringent safety requirements. These conditions challenge conventional manufacturing platforms, which have not or cannot adapt sufficiently to address these changes. Crucell’s PER.C6^® technology has been designed to meet these demands.

Crucell’s PER.C6^® cell line is derived from a single, human retina-derived cell, which was purposely immortalized using recombinant DNA technology.  As a result, PER.C6^® cells can replicate indefinitely, allowing them to be cultured in single cell suspension under serum-free conditions in quantities appropriate for large-scale manufacturing.

Crucell maintains extensive documentation on the origin, establishment, and characterization of the PER.C6^® cell line, establishing it as the most completely documented cell line to date.

Crucell’s PER.C6^® cell line is ideally suited for the development and large-scale manufacturing of a multitude of biopharmaceuticals. These include vaccines, therapeutic proteins including antibodies and gene therapy products. As a result, the PER.C6^® cell line has been licensed to a wide range of organizations and biopharmaceutical companies engaged in therapeutics development.

Availability

Crucell has established master cell banks and working cell banks (MCBs and WCBs), ensuring an indefinite supply of qualified PER.C6^® cells. In addition, the cell banks are an excellent source for generating novel PER.C6^®-based cell lines, expressing antibodies or other proteins of interest.

These novel cell lines can capitalize on PER.C6^® technology’s excellent safety record. All applicable safety and characterization tests dictated by regulatory guidance, including the ICH, FDA / CFR, EMEA and EP, have been performed on PER.C6^® master and working cell banks and have met or exceed standards set by these organizations.

All documentation on the origin, establishment, characterization, and safety testing has been included in a Biologics Master File (BMF). The BMF is updated on an annual basis in collaboration with Merck & Co., one of Crucell's PER.C6^® licensees. All of Crucell's licensing partners are authorized to refer to the BMF, which can benefit - and potentially accelerate - their product development efforts.

Experience

Over the years, Crucell has gained extensive experience using PER.C6^® technology. The PER.C6^® technology has been made suitable to perform well in a variety of culture formats including roller bottles, spinner flasks, wavebags and stirred tank bioreactors. Also, the PER.C6^® technology has been made suitable to perform well in a variety of production processes including batch, fed-batch and perfusion. Finally, the PER.C6^® technology has been made suitable to perform well in a variety of different commercially available tissue culture media. Crucell’s continued commitment to PER.C6^® technology is evident from the central role it plays in the company’s own in-house development programs.

Many of the internal and partnered programs executed by Crucell use the

PER.C6^® cell line and supporting PER.C6^® technology for development of products. In November 2006, Crucell and DSM Biologics established the PERCIVIA PER.C6^® Development Center, headquartered in Cambridge, Massachusetts, as a joint venture to further develop the PER.C6^® cell line and provide a unique solution for the production of pharmaceutical proteins to licensees utilizing the cell line.