Overview

Bioclone is an Australian-based subsidiary of Hitachi Chemical Co., Ltd specialising in the design and manufacture (including contract services) of high quality immunodiagnostic products for medical and research laboratory markets. Bioclone was formed in 1981 to take advantage of Australian expertise in medical research and biotechnology.

Bioclone now produces Australia’s largest range of immunoassay products for the medical diagnostics market. The products are marketed worldwide through a network of distributors.

Bioclone quality management system is fully certified to ISO9001:2000, ISO 13485, GMP, CE Mark and FDA clearance with 510(k) approval to market (10 ELISA products in the range).

Business Opportunities (i.e Corporate Alliances/Partnerships)

In addition to marketing its own products worldwide through some 45+ distributors currently, Bioclone also acts as the Australian and New Zealand distributor for some selected overseas companies (Agency Lines).

A number of strategic alliances exist to develop new products and promote several current products on an OEM basis.

Further to this, new pro-active, long established and well connected companies with experience in the distribution of immunodiagnostic products are always being sought to ensure sales coverage of Bioclone’s core range of products in all regions of the world.

Technology/Products and Services Description

The core range of Bioclone’s kits include tests for pregnancy, fertility monitoring, thyroid disease, anaemia, allergy,  growth factors, prenatal, neonatal and population screening and also some infectious diseases. The products listed are available for direct sale within Australia and internationally through distributors, including OEM (bulk components or private label for large quantities). Other products are in research and development.

Contract manufacturing and development services are also available: immunoassay kit manufacture; large-scale microtitre ELISA production; antibody production, including bulk production of monoclonals and immunoassay development (ELISA, IRMA, RIA and Chemiluminescent assays).

Competitive Advantages

Bioclone provides rigorous, yet low-cost, manufacturing and quality control and is very flexible to clients needs, given international quality guidelines through which it is regulated.

Bioclone’s ELEGANCE ELISA range features an amplified system for signal generation. All components have very long stability.

Website address: www.bioclone.com.au