Genentech has begun operating a second cell-culture plant at its massive Vacaville manufacturing complex, following approval in April from the European Medicines Agency to produce an under-the-skin treatment for certain blood cancers.
The new plant is part of a nearly $300 million, half-million-square-foot expansion that is set to almost double production of the Solano County site.
Genentech already produces the intravenous formulation of Rituxan, called Rituxan IV, at its first Vacaville cell-culture plant, called CCP1. The second facility, CCP2, was built in 2007 and shuttered in 2010 due to market demand and other issues.
To be used in the U.S., new Rituxan SC formulation required new clinical trials and a new FDA review. The new formulation includes the same monoclonal antibody as intravenous Rituxan and also hyaluronidase — a molecule that helps to deliver medicine under the skin. Rituxan IV has been the standard of care for treating B-cell non-Hodgkins lymphoma.
Genentech specializes in manufacturing biologics, a class of antibody medicines produced inside living cells designed to attach themselves to specific foreign substances in response to bacteria, viruses, fungus, animal dander or cancer cells, so the immune system can destroy them. Its Vacaville location is the largest producer of biologic materials for the parent company, the Swiss-based Roche Group. By 2018, Genentech and Roche will represent 25 percent of the worldwide biologics manufacturing capacity.
Tony Pankau, vice president and general manager at Vacaville, joined the company last November, following a 28-year career at Amgen. He said that once the Rituxan SC formulation is approved by the Food and Drug Administration for U.S. patients — anticipated by mid-year — Genentech can submit an application to the FDA for licensure of the CCP2 facility.
Rituxan SC is designed to reduce staff time and chair time for patients during the infusion process and when administering this drug. The company said studies have also shown that Rituxan IV and Rituxan SC have comparable efficacy and safety.
In addition to Rituxan IV, CCP1 produces three drug therapies for certain types of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla. It also manufactures Xolair for chronic idopathic uticaria — a type of chronic hives — and allergic symptoms, as well as Ocrevus for multiple sclerosis.
Genentech continues exploring and developing drugs for treating conditions such as Parkinson’s disease and Alzheimer’s disease. The company recently announced positive results based on two studies of its investigational hemophilia medicine emicizumab (shown in lower case until approved and given a brand name).
“Genentech expects more emicizumab results later this year and looks forward to submitting those findings to health authorities for approval consideration,” Pankau said. “Looking ahead, the company is also collaborating with German-based BioNTech to develop, manufacture and commercialize novel mRNA-based, individually tailored and personalized messenger RNA cancer vaccines.”
With more than 100 types of cancer variations identified, and with human immune systems unable to detect and effectively fight these cancers in most cases, new therapies are needed to apply targeted treatment.
CCP2 has potential to almost double the output of the Vacaville location. Five medicine batches of specific proteins are produced weekly at CCP1, enough to provide doses for 160,000 patients a week.
The annual output of CCP1 is 2,500 kilograms of various products, whereas the future output of CCP2 is expected to reach 4,000 kilograms. This output is in the form of vials of medications designed for infusion, injection and additional processing, not in capsule or tablet form.
Genentech gets FDA approval for Rituxan SC
June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL).
This new treatment includes the same monoclonal antibody as intravenous Rituxan (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.
“With today’s approval of RITUXAN HYCELA, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important.”