Press release 01-06-2017

Biotype Diagnostic GmbH further extends OEM business in 2017

Dresden, 1 June 2017. New field of business: Life Science Research & Manufacturing (LSR&M)
“OEM production has always been an important economic cornerstone for Biotype. Even now, our services already range from orders to develop and produce individual kit components to commissions for entire molecular genetic testing systems, extending as far as molecular reference standards. At the start of 2017 we finished improving our production department in line with GMP, bringing us another step forward, and our newly created LSR&M Unit means we are prepared for other exciting developments”, explains Dr Wilhelm Zörgiebel, the company’s CEO.

Many years of business with QIAGEN GmbH Germany
Since 2009, Biotype has been supplying QIAGEN Deutschland GmbH with forensic testing systems. At the same time, in 2016, several Modaplex development orders were successfully fulfilled for Biotype Innovation GmbH, a joint venture with QIAGEN, and passed on to the production department. The company is certified in line with ISO 9001/13485 and markets its own molecular diagnostics assays around the world. Its products include the multiplex PCF systems MycoDerm, to identify dermatomycosis, AMLplex, for acute myeloid leukaemia, and the chimerism products Chimera and DIPscreen/DIPquant, with the advanced DigitalScreen/DigitalQuant versions, excellent tools before and after stem cell transplants. 

Biotype’s expertise covers almost all multiplex PCR technologies for examining human, animal, bacterial and fungal DNA samples. In future, the company will also focus on demands related to companion diagnostics.

In the pipeline: hot-start Taq polymerase
The company’s extended OEM portfolio now also includes associated consumables used in molecular genetic assays, which are required to meet individual product specifications (such as guaranteed DNA-free kits). To this end, Biotype is about to start providing powerful hot-start Taq polymerase.

Effective solutions throughout the product manufacturing process
“We now even offer services related to the development and certification of IVD products”, explains Dr Kathleen Clauß, the product manager in charge of OEM. “This is because complex regulatory requirements, uncertainty about applying for funding, clinical studies or certification issues often prevent a product from being manufactured.”

This is the reason for Biotype’s foray into the OEM business: Any lack of experience on starting up can be balanced out by expertise; we take on tasks which established companies and global players cannot fit into their development or manufacturing schedule.