Genentech plans to double Solano Co. pharmaceutical plant output
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.
Though built 10 years ago, CCP2 was not operational for several years.
“Strategic decisions made about the timelines for starting up CCP2 were connected to an overarching strategy based on demand forecasts and production efficiencies across the entire Genentech/Roche global network,” Pankau said. “The exciting news is that as production demand has increased for our pipeline of more than 70 investigational medicines, CCP2 will now be able to provide us with much needed additional capacity.”
The second Vacaville cell culture plant on this 100-acre site was part of a $285 million expansion project that includes space for manufacturing, maintenance, laboratories, offices and warehousing. The entire 956,000 square foot facility employs over 1,000 workers, with some employees trained and certified to work in both plants. Of this total, CCP2 occupies 450,000 square feet of space, with 165,000 square feet devoted to labs and cell culture production made in accordance with the most stringent FDA protocols and procedures.