Production services according to GMP requirements: Joining forces in the pandemic

As a global Contract Development and Manufacturing Organization (CDMO), SANOCHEMIA provides a broad and high-quality offering with a “FULL-Service” concept for a long time. Customers and partners benefit from access to all development stages. Consequently, the utilization of existing site potentials and manufacturing competencies for other areas is a logical next step. Efforts to expand production services and use GMP know-how as well as the corresponding quality standards were successful very quickly. For two flagship projects, SANOCHEMIA is joining forces in the Corona pandemic and working in close cooperation with its customers.

Assembly and packaging of PCR self-test kits

SANOCHEMIA supports a major Austrian PCR test kit manufacturer in the assembly and packaging of patented PCR self-tests for Covid-19. Therefore, SANOCHEMIA assembles up to one million test kits per month at its facilities in Burgenland. Among other things, these tests are used by various countries and federal province as part of PCR testing activities. SANOCHEMIA acted as a scale-up partner for the customer and supported all phases of the project with its resources from the conceptual start to full operation. At times, up to 400 additional employees were deployed by the company for these manual processes.

Flexible manufacturing and logistics processes for innovative xPOC corona tests

In addition, Genspeed Biotech, a new customer in the field of GMP manufacturing, packaging and assembly of medical devices, is convinced of SANOCHEMIA’s capabilities. For the Upper Austrian company, multiplex point-of-care test kits (xPOC) for their patented rapid test devices have been manufactured in accordance with GMP requirements since April. The activities include the printing of chips with highly sensitive capture molecules, the assembly of the chip, the production of a carrier fluid by pipetting. SANOCHEMIA is currently manufacturing key components of the Covid-19 antibody test kit and will in future also carry out the final assembly of the medical product on site.

Genspeed Biotech’s multiplex tests are designed for use in doctors’ practices, pharmacies or emergency rooms, for example, and deliver laboratory-like results from a drop of blood within 15 minutes. The test chip used in the technology analyzes specific antibodies against three different antigens of SARS CoV-2 and is highly sensitive and specific compared to classical rapid tests.

Expansion of GMP-compliant contract manufacturing

In addition to the company’s focus on pharmaceutical production and contract manufacturing, the expansion of GMP production services is a complementary pillar that provides the company with a solid foundation for the future. In this context, the flexible manufacturing and logistics processes in accordance with GMP requirements and the proximity to a high-quality pharmaceutical environment offer potential of which customers can benefit to an increasing extent.

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