With the worldwide biopharmaceutical market projected to nearly double by 2032, and the pharmaceutical market expected to exceed $3 trillion by 2034, global specialty chemical company Evonik continues to make investments in its network of western-based facilities to better serve life science customers.

The Essen, Germany-headquartered company serves the biopharma and pharma markets across the product lifecycle, from early development to commercial manufacturing, including a portfolio of drug delivery technologies — oral and parenteral — as well as contract development and manufacturing organization (CDMO) services for active pharmaceutical ingredients (APIs), highly potent APIs (HPAPIs), and intermediates.

Evonik operates a global network supporting lipid and lipid nanoparticle (LNP) formulation development and manufacturing. Last week, the company announced the expansion of its lipid-based drug delivery capabilities with a new Good Manufacturing Practice (GMP) facility in Vancouver, Canada.

The company’s CAD 150 million ($108 million) investment will be supported by up to CAD 68 million ($48 million) in funding from the Canadian federal government’s Strategic Response Fund. The new facility will have more than three times the manufacturing capacity of Evonik’s existing Vancouver operation for advanced pharmaceutical products, while adding quality control and microbiological testing capabilities.

“The Vancouver expansion adds in-house quality control and microbiological testing capabilities that were previously outsourced, including USP methods for sterility, endotoxin, bioburden, residual solvents, particulate matter, and other drug product release assays,” Guido Skudlarek, head of the health care business line at Evonik, told Pharma Manufacturing.

Skudlarek said bringing these tests on-site will enable faster release of clinical materials and improve responsiveness for customers, noting that the facility’s primary role is LNP formulation development and GMP clinical manufacturing for nucleic acid-based medicines.

“As programs advance into Phase III and commercial production, manufacturing processes for LNP and liposomal products can be transferred to Evonik’s Birmingham, Alabama site, where additional manufacturing capacity and commercial-quality systems are available,” he added.

US and Slovakia investments

Evonik customers will benefit from the company’s integrated lipid and LNP network, which Skudlarek said supports the entire value chain from formulation design and process development through clinical manufacturing and commercial scale-up.

Evonik’s network includes lipid and adjuvant supply operations in Dossenheim and Hanau, Germany, research and development capabilities in the Greater Boston area, and a planned global-scale lipid production facility at the company’s Tippecanoe site in Lafayette, Indiana to expand U.S. drug substance manufacturing.

As part of a $100 million investment, Evonik is modernizing key manufacturing assets at the Indiana site, including 100-cubic-meter reactors and other critical production systems over the next five years.

“The upgrades are focused on improving manufacturing reliability, efficiency, automation, and ergonomics while preserving the site’s technology leadership,” Skudlarek said. “Replacing aging equipment also allows Evonik to recover and slightly increase available production capacity by restoring equipment to its full operational capability. In addition, the modernization supports sustainability goals through improved energy efficiency, reduced emissions, enhanced solvent and material retention, and the prevention of product losses during manufacturing.”

The overall objective of the capital expenditure is to strengthen Tippecanoe’s position as a leading U.S.-based CDMO hub and meet growing demand for increasingly complex pharmaceutical ingredients including HPAPIs, according to Skudlarek. Currently, the site includes HPAPI manufacturing capabilities, general API reactor capacity, and large-scale fermentation operations.

In April, Evonik announced an approximately €80 million ($93 million) investment to expand capabilities at its Fermas site in Slovenská Ľupča, Slovakia, adding downstream fermentation capacity to support contract drug substance manufacturing.

“Because downstream processing requirements vary depending on the product being manufactured, the expansion introduces several new technologies to improve scalability and efficiency,” Skudlarek said. “These include centrifugation systems for liquid-liquid separation, equipment for liquid-solid isolation, simulated moving bed chromatography for advanced purification, and additional reactors for chemical processing steps.”

To further enhance sustainability, he also noted that the Slovenská Ľupča site is adding distillation capacity for solvent recovery, helping reduce resource consumption and waste generation.