Orion offers contract manufacturing for high-quality cytostatics

With over 35 years of experience, Orion has acquired long-term expertise in highly potent, high-quality cytostatics manufacturing.

ORION CYTOSTATICS DEPARTMENT FACTS:

  • 35+ of experience: first established in 1982
  • GMP-compliant, inspected e.g. by FDA and EMA
  • Direct mixing and wet granulation processes
  • Experienced staff
  • New packaging area with serialization capacity opening in 2018
  • Capacity available for new contract manufacturing clients

 

Orion’s cytostatics department was first established in 1982. The very first product was Methotrexate, a chemotherapy agent used to treat forms of cancer and autoimmune diseases such as rheumatism and psoriasis. In fact, the same product is still manufactured in the department, and is a key part of Orion’s own product portfolio. 

We have been building our expertise in manufacturing of cytostatics for over three decades, so our staff has a lot of experience and skill in developing cost-efficient and reliable processes for this type of production,” says Olli-Pekka Kortepuro, Production Manager at Orion’s Turku plant, where the cytostatics department is located.

The most long-term contract manufacturing client has also used Orion as a CMO since the 2000s.

Long-term partnerships are important to us, and we have been able to help the client in developing the manufacturing and quality processes further.”

 

HIGH SAFETY REQUIREMENTS  

GMP-compliant cytostatics manufacturing requires special skill and care, as the APIs are most often highly potent.

The process demands and level of protection are high to ensure employee safety as well as to eliminate possibility of cross-contamination,” Kortepuro says. “More and more we at Orion are moving to closed processes, where the production area is fully isolated from the area used by the staff.”

The department runs both direct mixing and wet granulation processes. In 2018, a new packaging area will also be opened, equipped with serialization capacity.

 

CONTINUOUS DEVELOPMENT OF PEOPLE AND PROCESSES

Kortepuro emphasizes the skill and commitment of Orion’s staff as one of the competitive advantages in cytostatics manufacturing.

People are really eager to learn and develop processes forward. Our production staff, who in some ways have a demanding job description with the heavy special protective wear and equipment, has a very low turnover rate,” Kortepuro says.

There’s a certain extra motivation in this work, as you know that these products could end-up making a real difference in the lives of patients fighting cancer.”

 

Read more about Orion CM.