Biologics Production Growing

“With biologics, research and development (R&D) and production has never been greater,” Hintlian says. Overall, “biologics are facing tremendous growth,” he adds.

Strategically, biologics make a lot of sense, Hintlian believes. “Some of the newest and most important remedies are biologics-based; for example, in oncology.” The goal of such biologics-based cancer-treatment medicines, he notes, is to maintain and extend human life.

Tbo-filgrastim is one such example of a recently U.S. Food and Drug Administration (FDA)-approved biologic used in treating cancer. Manufactured by Vilnius, Lithuania-based Sicor Biotech UAB—part of Teva Pharmaceuticals Industries Ltd., Petah Tikva, Israel—the biologic received FDA approval at the end of August.

According to Teva, tbo-filgrastim represents the first new granulocyte colony-stimulating factor to be approved in the U.S. in more than 10 years. The medicine reduces the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who receive chemotherapy that affects the bone marrow, Teva says. The American Cancer Society says non-myeloid cancers include all types of carcinoma, all types of sarcoma, melanoma, lymphomas, lymphocytic leukemias and multiple myeloma.

The FDA explains that severe neutropenia is a decrease in infection-fighting white blood cells called neutrophils. That decrease leaves patients more susceptible to potentially life-threatening bacterial infections, Teva adds.

C. Kenna Amos, [email protected], is an Automation World Contributing Editor.