Lonza is producing Phase II supplies of Bertilimumab, a human immunoglobulin monoclonal antibody, for Immune Pharmaceuticals after inking an exclusive contract. Production will take place at Lonza’s mammalian development and manufacturing facility.
Daniel Teper, CEO of Immune, said: “Lonza understands the needs of emerging companies, providing assistance and flexibility, while maintaining the highest standards essential for regulatory compliance and successful partnering.“
JHP Pharmaceuticals is performing product transfer and manufacture of a registration batch for an unnamed pharmaceutical company. The product is a terminally sterilised life-saving treatment regulated by the US Drug Enforcement Agency.
"During the last six months, we successfully completed US Food and Drug Administration (FDA) and European Medicines Agency (EMA) audits in addition to entering agreements with four new contract customers”, said Stuart Hinchen, CEO and president of JHP.
Production will take place at JHP’s plant in Rochester, Michigan, which, claims the company, has “a solid history of successful partnerships, manufacturing clinical and commercial products
Experience working with Dendreon’s cancer vaccine has helped Progenitor Cell Therapy (PCT) win an expanded oncology contract. The client is entering the final stages of development and will be supported by PCT. If the product is approved PCT could be inline for commercial manufacture.
"For Dendreon, PCT facilitated the manufacturing and distribution of Provenge, a cell based therapy product for the treatment of prostate cancer that received FDA approval in 2010", said Robert Preti, president of PCT.
A second contract has also been expanded. The expanded terms will see PCT provide additional services to a client’s immune system disorder development programme. In January PCT was bought by NeoStem.