Biosynth

Biosynth is a supplier of of Fine Chemicals, Peptides and Key Biologics all from one trusted partner for product and services, headquartered in Switzerland but with additional global manufacturing facilities across Europe, the US and Asia.  The company is a world-leading supplier, manufacturer, and partner for the pharmaceutical, life science and diagnostic sectors, along with customers across the food, agrochemistry and cosmetics industries.

With an unrivalled combined offer of end-to-end development and manufacturing services and a portfolio of more than one million products, the Biosynth Group possesses a range of expertise and capabilities that covers the entire pharma value chain including complex chemicals, peptides, and key biologics. It maintains a science-led and customer-focused approach to solve problems, taking pride in delivering products and projects that others cannot.

Services & Products

Biosynth’s guiding vision has been to consolidate the highly fragmented and complex pharmaceutical supply chain with a range of essential and complementary services and materials available from a single reliable source.

Biosynth is viewed as a strategic partner by many of the world’s leading pharma manufacturers and research organizations, increasing their productivity by improving availability and reducing time-to-market of new therapies and diagnostics assays.

Biosynth’s huge catalog of Research Products spans all three of its service divisions:

• Complex Chemicals: With end-to-end manufacturing services that extend from first idea to finished product, Biosynth has the scale and quality required for secure supply chains with ISO and cGMP credentials. Experts in the most difficult and complex chemistry, key competencies include carbohydrates, nucleosides and enzyme substrates. The division’s offering includes bulk and custom products, route scouting and optimization, FTE services, large-scale (up to 10Mt) chemical manufacturing and analytical services. The team also excels in biocatalysis and green chemistry as well as bioconjugation.
• Quality Peptides: Biosynth‘s peptide services include discovery and optimization, multi-kilogram scale and GMP manufacture and well as high throughput custom peptide synthesis. The division handles activities including theranostics and neoantigen projects and peptide library production. Experts in peptide chemistry, the team provides long, complex and labelled peptides. Focuing on delivering excellence in peptide design and synthesis at small and large scale, as well as GMP manufacture of peptides for customers. The teams have extensive experience and operate out of five sites in the US, UK and Europe.
• Key Biologics: Supporting in vitro diagnostics and life science research, Biosynth supplies critical biological raw materials and runs custom production projects. This includes supply of antibodies and antisera (human and veterinary targets), viral and bacterial antigens and plasma. For research and development, specialist teams can provide enzyme supply and enzyme development. Biosynth also offers custom antibodies (polyclonal and monoclonal) along with epitope mapping services.

All products can be purchased from Biosynth online, with its website also providing a constantly growing resource for scientific, chemical, biological content, including blogs and articles on diagnostics topics and modern microbiology methods.

Technologies and Innovation

Biosynth’s core ethos is innovation, developing and commercializing a series of unique proprietary technologies, with examples that include:

• Aldol® Indicators: A series of novel chromogenic enzyme substrates for microbiological assays that overcome common drawbacks of conventional substrates by overcoming dependence  on oxidative dimerization for color development by attaching various enzyme labile groups (comprising beta-D-galactoside, acetate, alpha-D-glucoside, beta-D-glucuronide, phosphocholine, and N-acetyl-beta-D-galactosaminide) to  new dye precursors.
• AquaSpark™ phosphatase substrates: Co-developed by Biosynth and Prof. D. Shabat’s group at Tel Aviv University, AquaSpark™ molecules provide a new generation of chemiluminescence probes for research and diagnostic applications. These probes offer unique advantages in working as single agents with higher efficiency and sensitivity over currently existing probes both ex-vivo and in-vivo.
• X-Shining™ Luciferase: an inexpensive and highly sensitive luciferase enzyme that makes the huge benefits of bioluminescence detection methods more accessible in hygiene monitoring, microbiological food and drinking water control, as well as clinical microbiology.
• CLIPS™ Peptides: Our group of experts have developed a uniquely versatile and broadly applicable technology for constraining the 3D conformation of peptides, called CLIPS™ (Chemical Linkage of Peptides onto Scaffolds). Unlike other constraining methods, CLIPS™ chemistry can create redox-stable mono-, bi- or tri-cyclic and bi-bridged™ and is compatible with the presence of side-chain-unprotected amino acids. CLIPS™ peptides have shown their benefits in many areas.

Structure and history

Over almost six decades, Biosynth has become a well-established chemical company with multinational operations.

Biosynth was founded in 1966 by Hans Spitz, whose son, Urs Spitz, took over as CEO in 2004. The company first expanded its production facilities in 1985, adding new logistics and QC facilities in 2009 and a new production site in 2011.

During 2016, Biosynth acquired a major stake in Slovakian-based organic chemistry specialist TAU-CHEM and the following year added a new EU logistics hub, also based in Bratislava, while extending its GMP production facilities.

In 2019, a merger formed Biosynth Carbosynth as a world leader in carbohydrates, nucleosides and enzyme substrates. In 2022, it acquired both vivitide and Pepscan to develop its offerings in peptide manufacturing services. In the same year the acquisition of Ireland’s Aalto Bio Reagents, as well as, Austrian enzyme development experts EUCODIS Bioscience expanded the newly rebranded company to be known as Biosynth. Adding a range of biological products and key raw materials for clinical diagnostics including antigens and antibodies establishing the Biologics division.

In 2023 Biosynth Group was again enlarged to include Cambridge Research Biochemicals and Fitzgerald Industries International rounding out the biologics and peptide divisions.

Biosynth is owned by, amongst others, KKR, Ampersand and senior management. Its headquarters remain in Staad, Switzerland.

Biosynth has a global presence with sites in The Netherlands, Austria, Slovakia, Germany and China as well as two sites in the US and two in the UK among others.

Quality and Regulatory

Biosynth holds certifications for ISO 9001:2015, ISO 14001:2015, ISO 13485:2016, PDMA product development and management and CFDA certification in China, along with licenses to manufacture, store, ship and sell controlled substances. The sites in Switzerland and The Netherlands are GMP certified for production of chemicals and peptides respectively. Biosynth takes its responsibilities for sustainability seriously and works with sustainability organization EcoVadis for certification.

Biosynth’s experienced QA team supervises the quality and performance of all business and manufacturing processes, using an embedded quality management system, and performing regular internal audits. The Group quickly responds and adapts to market changes and requirements and ensures consistent compliance at all stages of the supply chain. Special attention is given to compliance issues, in particular to API manufacturing, testing and handling, change control requirements, method and process validation, controlled substance handling and proper documentation. The in-house Qualified Person (QP) can certify batch release on products from Biosynth’s Swiss GMP pilot plant, which all meet cGMP standards.