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Bioclone
Australia Pty. Limited is an Australian-based subsidiary of
Hitachi
Chemical Co., Ltd., specialising in the design and manufacture of high
quality immunodiagnostic products for medical and research laboratory
markets globally. Associated contract services are also provided by
Bioclone.
Bioclone
was formed in 1981 to take advantage of Australian expertise in medical
research and biotechnology. A collaborative project with the CSIRO and the
Garvan Institute for Medical Research gave Bioclone an excellent range of
monoclonal antibodies to pituitary hormones from which diagnostic kits
were later developed.
In 1996,
Bioclone was acquired by Hitachi Chemical Co., Ltd., however, the company
continues to trade under the Bioclone name as it has done since its
inception. In 1997, Bioclone moved to a new purpose-built facility with
expanded capacity for production, contract manufacturing and contract
research and development.
Bioclone
now produces Australia’s largest range of immunoassay products for the
medical diagnostics market. The products are marketed through a network of
distributors internationally and directly, generally on a standing-order
basis, domestically.
The
company has maintained a reputation for high quality products and services
with close customer contact being key to the understanding of market
requirements for immunodiagnostic tests.
Bioclone
achieved and has maintained quality-related certifications since its early
days. Currently Bioclone’s quality management system is fully certified to
ISO 9001 (current edition), ISO 13485 (current edition), GMP and the CE
Mark; and Bioclone has US FDA clearance with 510(k) approval to market for
ten ELISA products in the range.
Bioclone
continues to invest in innovation and new product development both through
collaboration with research organisations and its own Research and
Development team. Additionally, the company is constantly seeking new
strategic alliances to augment established relationships made, over more
than 25 years in the biotech industry.
FACILITIES
Bioclone
relocated to new premises in 1997. This factory, including a head office,
was custom-designed for the development and manufacture of
immunodiagnostic products. The site houses spacious, clean,
air-conditioned and well-equipped laboratories, providing an excellent
working environment for flexible operations for production, quality
control and research and development departments in addition to offices
and computer facilities for administration and marketing.
Essentially all components are manufactured in-house with modern equipment
by Bioclone’s highly-trained, skilled workforce. Good manufacturing
practices are in place to conform with Australian and overseas
regulations. In 2006, significant upgrades to ELISA microtitre plate
coating and processing machinery were implemented.
Comprehensive, yet flexible, immunodiagnostic process facilities,
equipment and activities include:
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Laboratories
for production and packaging of ELISAs and other types of diagnostic kits.
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Clean room
suite set up for immunodiagnostics manufacture.
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A “Hot Lab” for
production of I125-labeled
products for IRMAs and RIAs.
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Cell culture
facilities for hybridoma production in a clean room environment.
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Large-scale
automated antibody production facilities and down-stream processing
equipment.
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Liquid-handling
equipment for semi-automated manufacturing processes, for bulk reagent
formulation, filtration and filling.
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Walk-in cold
rooms and freezers.
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Large-scale
freeze dryer & ELISA plate coater/processor - both also available for
contract manufacture.
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All necessary
equipment for development of new diagnostic products.
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A quality
control laboratory with appropriate testing and computer equipment through
which all products must pass for testing and approval before release.
© Bioclone Australia Pty Limited
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