Lonza certification and committee changes

Lonza Bioscience Singapore has received cGMP certification from the Singapore Health Sciences Authority (HSA) for its cell-therapy manufacturing facility.

The audit/conformity assessment, performed by the HSA, confirmed that Lonza Singapore has maintained an overall acceptable level of compliance with the Pharmaceutical Inspection Convention/Co-Operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products (Part I) relating to finished products.

PIC/S guidelines to GMP for Medicinal Products (Part I) require that the company is compliant with the standards required for: quality management; personnel, premises and equipment; documentation; production; quality control; contract manufacturing and analysis; complaints and product recall; and self inspection.

This encompasses all the recommendations of the World Health Organization (WHO) in relation to GMP.

“We are proud to be one of the first cell-therapy contract manufacturers in Singapore to have received this certification,” said Michael Cicio, Vice President of Operations. “This certification will allow Lonza to contract manufacture investigational medicinal products for aseptically prepared cell-therapy products and will facilitate the use of these products in both the United States and Europe.”

Lonza Group has meanwhile announced changes in the composition of its executive committee (EC). As of 1 July, Marc Funk will take on the role of COO of the Pharma&Biotech segment, replacing Stephan Kutzer, who has decided to leave the company.

Funk has been the company’s chief legal officer and board secretary since 2009 - roles he will continue to hold during the transition period until his successor is named. He has also been a member of the EC since 2012.

“He has already successfully managed operational and commercial projects in the Pharma&Biotech network and has been responsible for global quality in Pharma&Biotech for more than a year,” said Richard Ridinger, CEO of Lonza. “He has broad experience in this field as he was formerly co-founder of a biotech research company and has had a strong commercial focus in other parts of his career. I am confident he’ll be able to steer that segment through this critical growth phase and into the future.”