Almac Pharma Services Supports Rapid Launch of BioLineRx’s APHEXDA® (motixafortide)

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, has successfully supported the commercial packaging and rapid launch of BioLineRx’s APHEXDA® (motixafortide) into the US market.

APHEXDA®, which is administered by injection, was approved on 11 September 2023 by the U.S. Food and Drug Administration (FDA) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

Multiple myeloma is an incurable blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. It is estimated that more than 35,000 people will be diagnosed with the disease and 13,000 will die due to the condition in the US in 2023, according to the American Cancer Society. The symptoms of the disease include bone pain or fracture, low red blood cell counts, fatigue, high calcium levels and kidney problems or infections.

A multi-departmental team comprised of specialists from Almac’s New Product Introduction (NPI), Planning, Quality Control, Quality Assurance and Artwork departments collaborated with the BioLineRx team to gain a full understanding of the product, approval timelines, various considerations, handling and distribution requirements.

Leveraging Almac’s expertise and experience in launch programmes, the teams worked in true partnership to assess various launch models and together agreed a tailored framework to efficiently, and effectively prepare, label and pack the treatment for immediate distribution upon FDA approval ensuring patients’ needs were met on time.

Asaf Aloni, VP Global Supply Chain, BioLineRx commented: “We engaged with Almac Pharma Services about a year before the expected launch. 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, commented: “Congratulations to BioLineRx on this fantastic achievement.  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’ reliability and commitment to partnering to advance human health is most visible through key partnerships with companies such as BioLineRx, who are working to advance life-changing treatments and therapies to patients.

As part of the Group’s ongoing global expansion investment totalling £400m, the company recently announced the completion of a 32,000 square feet custom-built high-volume facility that significantly increases its existing commercial manufacturing and packaging capacity.