The new MAT kit is a potential winner for the future.
Swiss contract research and service provider Solvias achieved a third consecutive year of growth in 2016, with a 2.2% increase in sales to CHF 65.3 million, and profitability up “significantly.” The year saw a number of commercial highlights, most notably the development of an in vitro monocyte activation test (MAT) kit for pyrogen detection, which will be distributed by the Life Science business of Merck KGaA.
“We have achieved very solid results over the last three years by building on our scientific strengths and technical expertise in support of our customers, who need to meet increasing regulatory demands,” said CEO Karen Huebscher.
The MAT kit, which is targeted for launch this year, will be used to detect fever-inducing pyrogens, which are bacterial, viral or fungal substances that typically come from chemicals or surfaces. Regulatory agencies require testing for them in many areas, including the batch release of injectable pharmaceuticals products and implanted medical devices and on certain pharmaceutical raw materials, as an essential part of quality assurance.
The MAT kit, which Solvias has been working on for nearly ten years, is based on the Mono Mac 6 cell line. These human monocytes produce cytokines like interleukin-6 when they come into come into contact with pyrogens, which can then be detected with enzyme-linked immunosorbent assay (ELISA) tests. The MAT was introduced into the European Pharmacopoeia in 2010 and the suitability of the Mono Mac 6 for this assay was proven in an international ring validation in 2009.
The kit will be marketed as an alternative to conventional animal testing, which is increasingly discouraged, and as such is seen as meeting an unmet market need. The standard test is to inject the test substance into live rabbits and look for the onset of fever. An alternative, limulus amebocyte lysate (LAL), is based on blood from horseshoe crabs, but can only detect pyrogens of bacterial origin and thus has limited value. These are markets of about $200 million and $1 billion/year respectively, so the potential market is vast.
During 2016, Solvias also drove major customer-centric, value-generation programs as part of its ‘Lean’ transformation, which included implementing ‘5S’ in all of its laboratories and a comprehensive training program for all employees, plus further expansion of the technology base, notably in elemental and trace element analysis. Other highlights included:
- A doubling of revenue, following on from major customer outreach efforts on both the East Coast and West Coast
- Strong continued growth in large molecule analytics
- A general increase of the company’s presence in biopharmaceuticals, biotechnology, medical technology and cosmetics
- Increased demand for elemental impurity analytics through inductively coupled plasma mass spectrometry with metal-free sample preparation, as required by ICH guideline Q3D
- The discontinuation of waste water analytics and fluorination chemistry
- The addition of Ni-Josiphos complex catalysts and TRIP organocatalysts to the portfolio
Based at Kaiseraugst near Basel, Solvias is majority owned by its management and employees. Its main offerings are analytical services, small molecule and biopharmaceutical analysis, solid state development, ligands and catalyst technology and custom synthesis and manufacturing. Products include analytical kits, ligands, fiber-optic probes and flow cell software.
The company added that it expects to “continue on a steady growth trajectory” this year. “There continues to be an increased trend towards outsourcing of product quality testing, characterization and analysis. This is where Solvias can take out the uncertainty early on in product development and also deliver data on consistency later on in production for both small and large molecules, medical devices and cosmetics.”