Laureate Pharma wins Seattles Genetics contract
produce Seattle Genetics' humanised monoclonal antibody product
candidates for clinical trial, adding to its experience in
monoclonal antibody development.
Laureate Pharma will perform scale-up and current good manufacturing practice (cGMP) production of SGN-33 and SGN-70 humanised monoclonal antibody product candidates using mammalian cell culture and standard antibody production methods.
SGN-33 (lintuzumab), currently undergoing a phase I clinical trial, is a humanised monoclonal antibody that targets the CD33 antigen, which is highly expressed on a number of hematologic malignancies and several myeloproliferative disorders, but has limited expression on normal tissue.
SGN-70, now in preclinical development, is a humanised anti-CD70 monoclonal antibody that has demonstrated antitumor activity and potent effector functions in preclinical models of hematological malignancies.
The manufacturing campaigns will provide clinical-grade drug product to support both the rapid advancement of SGN-33 in ongoing clinical trials and the planned initiation of SGN-70 clinical trials in 2007.
"The manufacturing will be carried out with stir tank reactors in a multithousand litre scale," said Morris Rosenberg, senior vice president of development at Seattle Genetics.
"We know how to scale production up to commercialisation and Laureate have a lot of experience in the manufacturing of monoclonal antibodies."
The production will take place at Laureate's cGMP facility at monoclonal antibodies in Princeton, New Jersey.
Apart from monoclonal antibodies, Laureate also focuses on recombinant protein products and provides a wide range of development services from process design and development to full-scale cGMP production, purification and aseptic filling, as well as corresponding testing, validation, analytical services and regulatory support.
Earlier this month, Laureate announced a manufacturing agreement with Iconic Therapeutics for cGMP production of hI-con1, a bi-functional immunoprotein for the treatment of wet adult macular degeneration and many solid cancers.
A bi-functional immunoprotein contains two functional domains connected by a "hinge", and each portion has a specific role to play in the protein's activity, so one domain of the hI-con1 is a "homing sequence" that targets pathological cells whereas the other portion, the "effector sequence", is the part of an antibody that signals the immune system to destroy the targeted cells.
Laureate's services for Iconic Therapeutics will include cGMP protein production, purification and aseptic filling.
In January, Laureate bowed out of its major contract manufacturing role with Discovery Laboratories by selling its Totowa, New Jersey, operations to the biotech company for $16m (€13.5m) in order to expand its bioprocessing services at its Princeton, New Jersey Facility, where the majority of its contract manufacturing revenues over the past two years has been generated.
