Paras Biopharmaceuticals Finland Oy successfully develops biologically active Romiplostim production technology
Paras Biopharmaceuticals Finland Oy today announced the achievement of a major milestone – the successful development of biologically active Romiplostim (N-Plate® biosimilar) production technology.
Romiplostim has been produced with a proprietary and innovative continuous manufacturing process at the company’s Finnish-based facility in Oulu-Finland. Romiplostim is used for the treatment of thrombocytopenia (low platelet count) in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
ITP is a potentially serious blood disorder characterized by increased destruction and impaired production of platelets. It can lead to extensive bruising and bleeding. Thrombocytopenia is common in cancer patients, resulting from chemotherapy or radiation treatment, in addition to the underlying disease itself. By manufacturing its first batches of the Romiplostim biosimilar, Paras Biopharmaceuticals is in a position to prepare to initiate GMP batches of the drug substance and formulation in 2019 within its Romiplostim biosimilar development program.
“The development and implementation of this commercial-scale manufacturing process for Romiplostim is not only good news for the company but the wider healthcare environment,” said Dr Ashesh Kumar, CEO & Director: Biologics & Licensing at Paras Biopharmaceuticals.
“The company is evaluating completed batches to assess comparability and looks forward to finalizing this work in the anticipation of supporting clinical trials & approvals for commercial supply on patent expiry in Europe and USA,” added Dr Mark Jackson, Research & Admin Group at Paras Biopharmaceuticals.
Global occurrence of ITP is increasing, and a growing number of patients diagnosed/reported to be affected. Current costs of available medicines are very expensive primarily due to higher production costs and inefficient production processes. Current yearly treatment in USA can cost up to $55250 USD per year for each ITP patient. With Paras Biopharmaceuticals efficient production technologies, the company aims to provide affordable healthcare treatment options to patients suffering from ITP.
About Paras Biopharmaceuticals Finland Oy
Paras Biopharmaceuticals Finland Oy is a Finnish biopharmaceuticals company started in 2012. Comprising of protein scientists, bioprocess engineers and technologists, Paras Biopharmaceuticals’ team has strong experience in developing biologics in the most efficient manner.
Company main activities & offerings are in 3 major areas:
1. Contract development & microbial biologics manufacturing (CDMO).
2. Development & Licensing of Biosimilars.
3. Recombinant Bioprocess Enzymes – TEV protease and Recombinant Enterokinase.
Paras Biopharmaceuticals has a fully equipped microbial production facility in Finland for the production of recombinant therapeutic products. With a total floor area of 25,000 ft2 and a classified cleanroom of 4,300 ft2, other features include media and buffer preparation, live area (fermentation and harvest & extraction), purification suite (incl. +4°C cold room), final filtration and freeze-drying.
Paras Biopharmaceuticals has developed and is now offering clinical development and marketing collaboration for the following Biosimilars: Recombinant Teriparatide (Forteo® Biosimilar), Recombinant Anakinra (Kineret® Biosimilar), Analog Insulin Aspart®, Recombinant Rasburicase (Elitek® / Fasturtec® Biosimilar) and Recombinant Romiplostim (N-plate® Biosimilar). The company has achieved efficient and cost-effective production of high value biosimilars. Paras Biopharmaceuticals has developed a proprietary platform which includes Diabrid® Technology, Noblecleav® Technology and Biomultifold® Technology.
*Nplate® is a registered trademark of Amgen Inc.
Media Relations & Information, Paras Biopharmaceuticals Finland Oy
Dr Mark Jacksont