Biotech manufacturing capacity is expanding in North America

Pharmaceutical CommercePharmaceutical Commerce - July/August 2015

Viral products, IVIG and stem cell production is coming online

Springtime, the annual BIO meeting, and the general upswing in both commercial and investor activity in biotech (see p. 8) has brought a raft of new announcements of manufacturing capacity. Interestingly, most of the new announcements involve non-US companies expanding in North America.

Lonza (Basel, Switzerland) has announced the construction of a new 100,000-square-foot facility for viral and immunotherapy development and manufacturing in the Houston, TX (USA) area, complete with a fully segregated fill/finish suite. This new facility will more than double Lonza’s capacity for the production of viral genes and virally modified therapeutics.

The state-of-the-art multipurpose facility is expected to come online in the first half of 2017 and will include eight independent cGMP modular cleanrooms for 2,000 L-scale production in single-use bioreactors. Grade-B cleanrooms will also be constructed to continue the manufacture of EMA-regulated cell therapy products. The site master plan includes expanded process development and quality-control areas, shell space for future additional cleanrooms, and land for further potential expansions.

“The clinical landscape for targeted gene therapies continues to grow at a steady rate with new advancements in cancer immunotherapies and cardiovascular disease,” said Andreas Weiler, PhD, head of emerging technologies for Lonza’s Pharma & Biotech segment. “This investment will allow Lonza to be well positioned to meet the demands of this growing market and to remain at the forefront of the viral gene therapy industry. Our viral team has more than 20 years of experience in viral vector gene therapy that, when combined with our newly constructed leading edge facility, will provide a key advantage to our customers and ultimately to their patients.”

Meanwhile, in Canada, Green Cross Biotherapeutics Inc. has begun construction of a C$315-million blood-fractionation plant for intravenous immunoglobulin (IVIG) and albumin, said to be one of the largest greenfield projects in Canada and the first IVIG plant in that country. Green Cross Biotherapeutics is the North American arm of Green Cross (Yongin, South Korea); the project is also the result of a free-trade agreement between South Korea and Canada.

The facility, located in Montreal Technoparc’s Saint-Laurent campus, will have a capacity of 1 million L/yr. of plasma when production starts in 2019, a footprint of 225,000 sq. ft., and will employ 200.

In June, Grifols (Barcelona, Spain) announced the expansion of its own plasma fractionation facility in Clayton, NC. That plant will increase production from a current 3.2 million L/yr. to 6 million, starting this year. Grifols, which says that it manages 20% of global plasma capacity, notes that the $370-million investment represents the world’s largest single site for plasma production. Further expansions are planned at albumin purification plants in Los Angeles, CA, and a new warehouse at the Clayton complex.

Fractionation is the first step in the production of plasma-derived therapies, which involves subjecting plasma to various changes of temperature and chemical conditions, causing each of the proteins with therapeutic properties to separate out. These proteins have to be purified and formulated before they can be used as medicines. The medicines manufactured by Grifols from plasma include IVIG, for the treatment of primary immune deficiency and a neurological disorder called chronic inflammatory demyelinating polyneuropathy (CIDP); factor VIII, for the treatment of hemophilia A; albumin, to re-establish and maintain blood volume; and alpha-1 antitrypsin, for the treatment of genetic emphysema.

A purely US capital investment in biotech was announced by Allele Biotechnology & Pharmaceuticals (San Diego, CA), which purchased real estate near its headquarters to build a facility for producing clinical-grade, human-induced pluripotent stem cells (hiPSCs). The company has a proprietary “synthetic mRNA platform” to produce these cells, said to avoid the inclusion of foreign DNA or the use of viruses or virus elements. The facility is sized at 18,000 sq. ft.

The company says that it has recently made a number of advances regarding the differentiation of hiPSCs towards cells of specific lineages, such as neural progenitor cells, neurons, astrocytes, mesenchymal stem cells, cardiomyocytes, skeletal muscle cells, hepatocytes, and adipocytes, including brown fat cells. These cells would also be produced in the cGMP facility when intended for specific therapies.

One US-outbound investment announced during BIO was that of Thermo Fisher Scientific (Waltham, MA) expanding a cell-culture media production facility in Inchinnan, Scotland. The £14-million investment is to employ Thermo Fisher’s Advanced Granulation Technology (AGT) to produce what is called Gibco AGT powders, used in running cell-culture production of biologics and vaccines for Thermo Fisher clients. The Scottish facility complements existing Thermo Fisher production in Grand Island, NY; it also produces liquid media for research and production applications.

And one non-US biotech-related announcement was made in May by AstraZeneca, which will invest in a $285-million biologics filling and packaging facility at its site in Södertälje, Sweden, which is also the site for tablet and capsule production. Commercial production is expected in 2019 for AstraZeneca and its Medimmune subsidiary.

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