The life sciences firm has just finished the production and packaging of CuraGen's investigational metastatic melanoma drug, CR011-vcMMAE, an antibody-drug conjugate (ADC) consisting of CR011, a fully-human monoclonal antibody, linked to monomethyl-auristatin E (MMAE), a cell-killing drug payload.
For the first time Cambrex has demonstrated its ability to scale up such a process for bulk antibody production in its new cell culture bioreactor in Baltimore, Maryland, as well as the process for conjugating the antibody to MMAE, providing CuraGen with enough of the necessary material to advance its drug into Phase II trials.
The firm also carried out the necessary bioassay and fill/finish services, as well as assay transfer and qualification of the completed drug batches at its facilities in both Walkersville and Baltimore, Maryland.
"Cambrex did an excellent job manufacturing CR011-vcMMAE on time and within budget," said Dr. Steven Henck, vice president of operations at CuraGen.
Manufacturing of the CR011-vcMMAE molecule is tricky as it has multiple components as it combines both a biologic and a potent cytotoxic small molecule drug.
"Cambrex's ability to execute the antibody manufacturing, perform the conjugation, and complete the fill and finish of this antibody-drug conjugate helped facilitate our aggressive timelines and accelerate our path into clinical development," said Henck.
CuraGen's satisfaction with the service it received from Cambrex is good news for the company, which has been hit by lower long-term profitability projections for its Biopharma unit, as biotech companies seem to lose their appetite for outsourcing, and reported a $140.3m (€116.7m) loss in its fourth quarter in March, as opposed to a profit of $4.9m in the same period last year.
This is indicative of the current tendency of big biotech to expand its self-reliance and capacity rather than opt for the biopharmaceutical manufacturing services that companies such as Cambrex offer.
Genentech for example will boost its production capacity by 200,000 litres by 2009 and Amgen is currently building in Rhode Island what is expected to be the world's largest mammalian protein manufacturing facility.