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TECHNOLOGY FOR HUMAN TISSUE BANKS

MUSCOLOSKELETAL HUMAN ALLOGRAFTS


The Company Tissuelab S.p.A. was founded in 2003 with the aim to create a European Reference Centre for

research and development in biotechnologies and systems for reconstructive musculoskeletal surgery. Thanks to the cooperation with important companies operating in the Orthopaedic and in the Blood Banks fields, and to the technological know-how of their partners, Tissuelab has created in pharmaceutical grade laboratories for processing human osteotendineous tissue from donation, on behalf of Italian and foreign tissue Banks.

The processing facility is able to design and to formulate freeze-dried grafts such as: tissue

segments templates, demineralised bone matrices, for routine use in surgery, and specialty products worked out with a CNC equipment, in full respect of the quality and safety regulations.


stabilimento di S. Antimo - NAPOLI


The Process The complete process, starting from the plant to the manufacturing procedures, the quality

system and the management of the production is in accordance with the GMP standards for the manufacture of the pharmaceutical sterile products (Eudralex Vol.1 Medicinal Products for human and veterinary use: Good Manufacturing Practices Annex 1 Manufacture of sterile Medicinal Products) In particular:

Classified environments: the manufacture is carried out in environments with pharmaceutical

requirements, whose classification has been validated physically (particle counting, differential pressures between environments with different classification grade), microbiologically (environment validation “at rest” and “in operation” with air and surfaces biological monitoring) and operatively (fluxes diagrams for operators, materials and products).


The Safety System and equipment validation: the equipment and the crucial instrumentations are validated

according to the pharmaceutical standards following the IQ Protocols (Installation Qualifications), OQ Protocols (Operation Qualifications) and PQ Protocols (Performance Qualifications). Biological Banks (-80째C), autoclave, freeze-dryer, the demineralised bone powder machine, laminar flow equipment, cutting machine, etc. are part of these mentioned processes.

Process validation: Tissuelab has validated the

sterilization and viral inactivation process, the freeze-drying cycles and the tissue processing. Furthermore, the cleaning process of equipments, of the environments (microbiological and particulate analysis), and the autoclaving cycles for standard defined loads have been validated.

Terminal sterilization: the products undergo a viral inactivation and sterilization through the

Clearant method (sterilization with gamma rays at low temperatures with radioprotector soaking treatment) that guarantees a viral and microbiological safety as confirmed by ad hoc studies. The treatment performed in strict controlled conditions does not modify the biomechanical and biological integrity of the tissue. The sterility controls are performed in accordance to the European Pharmacopoeia for sterile medicines.

Mechanical and Biological Studies: the preservation of the mechanical and biological properties

of hard and soft tissues treated with Clearant method has been confirmed during the validation process. The maintenance of the osteoinductivity properties following demineralization, freeze-drying and sterilization has been evaluated see fig.1.


The Production Tissuelab manufactures a wide range of

human musculoskeletal tissues:

➢ Freeze-dried demineralised bone matrix (DBM) in granules and powder. Bone pastes and putties mixing the DBM with a carrier able to guarantee the suitable physical chemical and biological features the products. ➢ Soft tissues (ligaments and tendons), and hard tissues (cancellous and cortical bone) in different shape and size (chips, struts, cortical dowels, strips, blocks…). Hard tissues are presented in freeze-dried pharmaceutical form in a vacuum sterilized package , while the soft tissues are frozen at -80°C after sterilization. The Tissuelab process and the patent method of terminal sterilization/viral inactivation guarantees the maintenance of osteoconductive, osteoinductive and bio-mechanical properties of human tissues at the highest safety for the patients.

fig.1


Allograft and Substitute Characteristics Type of tissue:

Osteoconductive properties

Osteoconductive properties

Rejection

Synthetic

Provides a matrix for cell proliferation

None

None

Animal (usually bovine, porcine or equine)

Provides a matrix for cell proliferation

None

Recognised as a foreign body, strongly rejected

Cortical human tissue (eg. femur cortical chips/struts, fibular diaphysis)

Provides a matrix for cell proliferation

None

None

Support ability

As immunological response

Cancellous human tissue (eg. Bone chips, blocks)

Provides a matrix for cell proliferation

None

None

Demineralized human tissue

Provides a matrix for cell proliferation

None

None

Different formulations = different ability to support The tissue, depending on the type of cortical or cancellous and depending on the size, will influence its ability to provide local structural support Provides strong support for a transplant site Provides minimal structural support mainly used as a filler in reconstructions Provides minimal structural support, mainly used as a filler in reconstructions. It can be used on its own to extendent the patient bone with allograft or synthetic materials


The Prducts

Freeze-dried Tissues

• • • • • • • •

Cancellous chips2 – 5 -10 – 15 -30 cc Cortical/cancellous chips 2 -5 – 10 – 15 – 30 cc Iliac bicortical/tricortical Blocks Cortical struts Cortical rings Calcellous blocks Cortical shafts Fascia lata

Freeze-dried DBM Tissues

• • • •

DMB Powder 0,5 -1 – 2 – 5 -10 -15 – 30 cc DBM Cancallous chips 10 -15 -20 – 30 cc DBM Cortical/cancellous chips DBM Cortical struts

• •

DBM Putty 1 – 2,5 – 5 -10 cc DBM Blend 10 -15 cc

Frozen soft tissues

• •

Patella ligament Emi-Patella ligament

• • • • •

Achilles tendon Emi-Achilles tendon Gracilis tendon Semitendinous tendon Tibialis tendon (ant./post)


Head Office and Facility Address:

Tissuelab S.P.A. S.S. 7 Bis Km. 19,5 - 80029 S. Antimo (NA) Tel: +39 081 5059934 Fax: +39 081 5059913 P.IVA CF e Reg. Impr. di Napoli 04478671219

www.tissuelab.com info@tissuelab.com

TissueLAB: Company Profile  

TissueLAB: Company Profile

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