Biologics Production Growing

The biggest challenge life sciences—which includes biologics, biotechnology and, generally, large-molecule therapeutics—faces now includes rapid growth, exclusivity around products and the ability to command much more substantial margins, says Jamie Hintlian, vice president for pharmaceuticals at Aspen Technology Inc. (www.aspentech.com), Burlington, Mass.

Aw 13270 Biologics

“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, ckamosjr@earthlink.net, is an Automation World Contributing Editor. 

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