BRUSSELS, Belgium - The European Commission (EC) has detailed progress on a number of ongoing biotechnology research projects it supports.

The disclosure marks a new departure for the EC in a bid to boost understanding of, and sympathy for, what the European Union (EU) is doing for biotechnology in its US$3 billion-a-year overall program of scientific and research support. The projects include the following:

Gene Therapy

Gene therapy is the goal in a project on in vivo delivery of therapeutic antibodies via engineered cells. The first step was to demonstrate the technical feasibility of rendering cells non-specialized in the production of antibodies (non-B cells) able to produce cloned antibodies both in vitro and in vivo.

The second step was to develop a new technique for implanting antibody-producing cells in vivo using capsules made of cellulose sulphate.

The third step was to validate the therapeutic potential of this approach by seeking to treat mice infected with a virus.

Work is ongoing to optimize the implantation procedures and validate the therapeutic efficacy on other disease models. The project started in December 1996 and will last for 24 months, with an EU contribution of $115,000.

Protein-Free Media Drug Production

Another project is aiming to assess the benefits of using protein-free media in industrial processes with mammalian cell cultures producing biopharmaceuticals. Chiron Behring GmbH & Co., of Marburg, Germany, Pharmacia & Upjohn, of London, and two research institutes in the EU have been working jointly since September 1997 to evaluate applications in mammalian cell cultivation and production. The project will run 36 months, with an EU grant of $1.5 million.

The objective is to demonstrate the applicability and economic and practical advantages of protein-free media using the new, effective protein-free SMIF media line and a corresponding cell adaptation protocol that will be applied to current industrial processes with mammalian cell cultures producing pharmaproteins and vaccines. It could lead to improvements in biopharmaceuticals. The EC says that, due to the spectrum of methods and production processes used by different European pharmaceutical companies, demonstration of the application of protein-free media needs the concerted effort and cooperation of highly competitive manufacturers and research institutes involved in the production of biopharmaceuticals.

Psychrophilic Enzymes

Coldzyme is a project focused on molecular characterization of cold-active enzymes from psychrophilic (that is, cold-active) microorganisms as the basis for novel biotechnology. Its overall objective is to make possible the biotechnological exploitation of psychrophilic enzymes, by gaining an understanding of how proteins are folded to be active at low temperatures and how they are regulated in psychrophilic microorganisms.

The program, coordinated by Nick Russell, of Wye College, University of London, establishes a technical platform for the development of a range of new products and processes - such as washing powders active at low temperatures or highly efficient contact lens cleaning solutions.

The project's partners - 12 EU companies and research institutions - also are studying the psychrophilic bacteria themselves, with a view to using them as “cell factories“ to produce large quantities of genetically engineered cold-active enzymes.

Coldzyme already has succeeded in crystallizing enzymes that degrade starch and protein. The project, started in December 1996, will run for 36 months. The EU contribution is $1.5 million.

DNA Vaccines

A new EU network is evaluating the potential of nucleic acid-based vaccination together with a novel cell-based antigen delivery system for induction of antiviral immunity, compared with other types of vaccination using more classical immunogens.

The project brings together six European laboratories in the fields of hepatitis C vaccine research, immunology, DNA vaccination, antigen production and large-scale DNA purification for human trials. Two companies also are involved in the project - Biocine, of Siena, Italy, and Innogenetics, of Ghent, Belgium. The project was started in December 1996 and has a duration of 40 months, with an EU contribution of $1.5 million. *