Dutch scheme extends helping hand to biotech SMEs - Lyophilization Articles & Reports

Dutch scheme extends helping hand to biotech SMEs
02/03/2005
NOVIS
The Netherlands has set up a programme to boost its biotechnology sector by helping small and medium-sized biopharma firms to develop and manufacture products, writes Phil Taylor.
The scheme ? called BioConnection ? is a collaboration between the Dutch government, Akzo Nobel and the wider business industry, and is claimed to be the first ?one-stop-shop? in Europe to offer start-up biopharmaceutical companies the use of dedicated, centralised production facilities, as well as other activities such as formulation development.
The aim is to provide a boost for the Dutch biotechnology sector, which ranks eighth in Europe with 138 companies at the end of 2003, employing 2,100 people and with an overall turnover of ?170 million, out of a total European biotech sector turnover of ?11.1bn in the same year. For comparison, the biotech industry in Europe?s largest player, the UK, has revenues of over ?4.4bn and accounts for over 40 per cent of all biological drugs in trials across Europe.
Akzo Nobel?s healthcare business Organon is at the heart of the project, and will house the BioConnection biotechnology centre at its Oss site in the Netherlands
The programme?s manager, Marjo Peters, told In-PharmaTechnologist.com that BioConnection will run as a business, and the aim is to provide development and production facilities on a fee-for-service basis for companies who would struggle to implement these functions in-house, or indeed book slots at over-stretched contract manufacturing organisations (CMOs).
At present Organon is the only supplier into the programme, but the network will be expanded steadily to expand the range and choice of services available to SMEs.
The Dutch government and Organon are putting ?15m into the project, with the bulk of this money going towards the establishment of a lyophilisation (freeze-drying) unit at Oss. This is being built as part of Organon?s previously disclosed plan to construct a new parenteral medicines production plant, due to come on-line in 2008.
?There are not too many US Food and Drug Administration (FDA)-approved freeze-drying facilities available; those that exist are focused on larger customers and are often fully-booked,? said Peters, who is employed by Organon.
Freeze-drying is used to preserve the shelf life and biologic activity of the vast majority of biopharmaceutical drugs, with the resulting powder reconstituted with water ahead of administration to the patient.
At a press launch for the project, Toon Wilderbeek, Organon?s president, said: ?Organon wants to be more open, more collaborative and more active in biotechnology." The lack of such facilities has, until now, proved to be a serious hindrance to the continued development of the biopharmaceutical sector and the emergence of new drugs, he added.
BioConnection will be able to handle around 70-75 batches of clinical trial materials a year from Organon's faclities alone, and this will increase as the company's parenteral facilities come on-line and as new partners join the scheme, said Peters.
Having been granted user rights to the Organon facilities, start-up biopharmaceutical companies will have access to an installation which meets safety and production requirements for the manufacture of medicines, from small-scale tests right up to large-scale commercial production.
Similar schemes aimed at improving the access of small biotech players to development and production facilities have been set up in the UK and France, with the UK project leading the field at present with a dedicated facility ? the National Biomanufacturing Centre ? due to start operating in early 2006.