Ilika plc - Altrika participates in joint MHRA & HTA inspection & receives renewed regulatory authorization for Myskin/Cryoskin
10 Jun 2010
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.
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.
