CDMO News

Almac and BioLineRx Partner for APHEXDA® Launch in the US

  • Almac Pharma Services supports BioLineRx’s US launch of APHEXDA®
  • APHEXDA® approved by the FDA for multiple myeloma treatment.

Almac Pharma Services, part of the Almac Group, has successfully supported the commercial packaging and rapid launch of BioLineRx’s APHEXDA® (motixafortide) into the US market. The treatment, approved by the FDA on 11 September 2023, is used to mobilise hematopoietic stem cells for autologous transplantation in multiple myeloma patients.

Multiple myeloma, a blood cancer affecting plasma cells, is estimated to be diagnosed in over 35,000 people in the US this year, with 13,000 deaths expected. Symptoms include bone pain, low red blood cell counts, fatigue, high calcium levels, and kidney issues.

A collaborative team from Almac, including specialists from New Product Introduction (NPI), Planning, Quality Control, Quality Assurance, and Artwork departments, worked with BioLineRx to understand the product, approval timelines, and handling requirements. This partnership enabled a tailored framework to efficiently prepare, label, and pack APHEXDA® for immediate distribution upon FDA approval.

Asaf Aloni, VP Global Supply Chain at BioLineRx, stated, “Almac’s teams worked tirelessly and professionally to help BioLineRx launch successfully on the date set by the company. Almac’s true strength lies in its employees and their dedication to help clients achieve their goals.”

Grainne Hughes, VP Business Support Operations at Almac, added, “We are pleased to have shared our knowledge and experience with the team to enable the successful rapid launch of this much-needed therapy to patients in the US. We wish BioLineRx continued success as we look forward to developing our partnership to supply many more patients in the years ahead.”

Almac Pharma Services’ commitment to advancing human health is evident through key partnerships with companies like BioLineRx. As part of its £400 million global expansion, Almac recently completed a 32,000-square-foot high-volume facility, significantly increasing its commercial manufacturing and packaging capacity.

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