Cordlife loses accreditation with international blood bank body

SINGAPORE: Private cord blood bank Cordlife has lost its accreditation with the Association for the Advancement of Blood and Biotherapies (AABB).

In a filing on the Singapore Exchange (SGX) on Thursday (Aug 15), Cordlife said that the international blood bank body has withdrawn its accreditation for the collection, processing, storage and distribution of cord blood.

The AABB sets standards for quality and safety for blood and biotherapies groups. It currently accredits over a thousand blood banks around the world.
Cordlife said that upon AABB’s request in June 2024, it provided an update on the Ministry of Health’s (MOH) notice to extend its suspension for up to another three months.

From June to September, the company has to stop the collection, testing, processing and storage of any new cord blood, said Cordlife.

The extension came after a six-month suspension that started in December 2023.
According to Cordlife’s latest statement, AABB had notified that it can accredit the company only after MOH permits it to resume business and when the company has fully resolved all quality issues and has several months of records available for on-site inspection.
Cordlife was also told that the continued closure of its cord blood banking services “makes it impossible for AABB to identify non-conforming products, processes and events, as well as successful implementation of corrective measures supporting the AABB accreditation standards”.
Cordlife can seek accreditation again once MOH allows the company to resume operations, the company said.

“If an application is made, the company will follow the same accreditation process with a self-assessment followed by an on-site evaluation of the efficacy of the company’s quality management system.”
Upon getting the green light from MOH to resume operations, Cordlife “will evaluate the feasibility of seeking AABB accreditation at a suitable time”, it added.
Cordlife added that it does not expect the loss of its AABB accreditation to affect its business operations and financial performance for the rest of the year.
In December 2023, Cordlife lost its cellular therapy accreditation with the Foundation for the Accreditation of Cellular Therapy (FACT).
The suspension will last indefinitely, “at a minimum until FACT’s investigations are completed and issues are resolved”, Cordlife said then.
In a separate filing, Cordlife posted a loss of S$12.35 million (US$9.4 million) for the first half of the year, compared to a net profit of S$2.2 million in the same period a year ago.
The decline includes about S$9.7 million for the waiver of subsequent fees for clients who had stored cord blood in its high-risk tanks, as well as contract liabilities related to future storage obligations of affected clients.
Seven of Cordlife’s 22 storage tanks were found to have been exposed to temperatures above acceptable limits in November 2023. 
Around 2,200 cord blood units belonging to approximately 2,150 clients were damaged, with about another 5,300 cord blood units stored in a second tank and a dry shipper deemed “non-viable” by MOH.
Cordlife’s revenue for the first half of the year was S$9.2 million, a sharp drop from S$28.3 million in the same period a year ago. 

The decline in revenue for 1H2024 is mainly due to the suspension of the Cordlife Group’s Singapore operations, the company said.
Cordlife’s Singapore operations, which had been the largest revenue contributor, are expected to continue to be affected by the ongoing suspension and investigations, said the company.
“Cordlife will continue to work closely with the MOH to investigate and address the identified lapses at its Singapore operations.”
The company noted that it has “stepped up its rectification efforts during the period under review”.
It said that an oversight committee was created in May 2024 that comprises certain directors and management and will help address Cordlife’s current challenges, including the appointment of a new audit firm.
Cordlife added that it established a medical and technical advisory board in June 2024 to provide guidance and insights to its teams.
Since July, Cordlife said it has been working with Shandong Qilu Stemcell Engineering to assist its Singapore team during the rectification period. 

Shandong Qilu Stemcell Engineering is a subsidiary of Nanjing Xinjiekou Department Store, which has a 20.3 per cent stake in Cordlife. It operates in China’s Shandong province and has around 1 million cord blood units in its cord blood bank. 
There are also plans for Cordlife’s Philippines operation to offer a range of diagnostics tests and routine prenatal screenings.

“Despite the exceptionally challenging first half, we have continued to strengthen our processes, rectify our operations, and update our stakeholders with the goal of resuming our operations in Singapore to full strength as soon as possible,” said Cordlife group CEO Ivan Yu.
“We are also exploring new business opportunities in other markets to mitigate the impact of our Singapore operations,” he added.