Inspection, Regulatory Author

RNS Number : 4091N

Ilika plc

10 June 2010

 



10 June 2010

Ilika plc

Altrika participates in joint MHRA and HTA inspection and receives renewed regulatory authorization for Myskin® and Cryoskin®

Ilika plc is pleased to announce that Altrika Ltd, its wholly owned subsidiary, hosted the first joint inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA).  The MHRA and HTA approached Altrika as an ideal organization to initiate their new inspection approach to establishments whose activities fall under both of their remits.  Altrika's facilities in Sheffield, which have been licensed by the HTA since 2006 and MHRA since 2008, produce skin cell treatments for severe burns (Cryoskin® and Myskin®). Both these products share a common production platform, but as only one is classified as medicinal they are separately regulated.

Following the successful inspection outcome, Altrika has been invited to contribute to the HTA's Annual Report and Annual Review event in June.

"We are very pleased to have been selected to act as the first joint inspection candidate and work with the regulators to help make the inspection process more efficient" said Graeme Purdy, Altrika CEO. "It is testament to the skills and dedication of our staff, and the standard of our facilities that this joint inspection has gone so well and it demonstrates our commitment to the quality of our operations."

Cryoskin®, using Altrika's in-house GMP donor keratinocyte cell bank, is supplied under a Manufacturer's Specials Licence from the MHRA, whilst the provision of Myskin®, using the patient's own cells, is currently regulated by the HTA. Both products are available in the UK and undergoing pan-European approval.

For further details, please contact:

Ilika plc	Altrika Ltd	Pelham Bell Pottinger (Financial Public Relations to Ilika)
Tel. [phone]	Tel. [phone] Mobile. [phone]	Tel. [phone]
Graeme Purdy Chief Executive Officer	Richard Snell, Business Development Director	Archie Berens Olly Scott Francesca Tuckett

About Altrika Ltd.:  Altrika Ltd. is a wholly owned subsidiary of Ilika plc, a global leader in high throughput materials discovery. The Company was founded in December 2008 to focus on the development and exploitation of novel materials in the biomedical sector. Altrika works with leading medtech companies to identify novel materials for specific applications, as well as developing solutions in-house for the next generation of medical products. Altrika runs a GMP manufacturing facility in Sheffield, UK, licensed by both the UK Human Tissue Authority (HTA) and Medicines and Healthcare products Regulatory Agency (MHRA) to supply its Cryoskin® and Myskin® services on a named patient basis exclusively at the request of, and under the responsibility of, the treating clinician.

 

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