EAST RUTHERFORD, N.J.—Cambrex Corp. recently announced the completion of an expansion of its biopharmaceutical analysis capabilities at the company’s Durham, N.C., site. Biopharmaceutical analysis services were initially launched at Durham in 2018, and have since been expanded through the purchase and implementation of various method development, validation, release and stability functions, as well as endotoxin testing.
“The expansion began in response to a customer request to support a BioSafety Level 1 (BSL1) organism and grew from there based on broader customer response,” said Dr. Elliott Franco, site director of Cambrex Durham. “We remain committed to adopting the best-in-class technologies customers need access to. Our comprehensive expertise, coupled with a transparent, safety-driven approach to implementing the new equipment, allow the Cambrex team to better serve customers across the life of their processes.”
Following this expansion, the Durham site now features a range of new instruments, including particle analysis, imaging, qPCR, fluorescent/absorbance plate reader, immunoblotting, mass spectrometry and other compendial testing apparatuses. The new capabilities are applicable to a broad variety of biopharmaceuticals, including bacteriophage/bacterial virus and mammalian viral infectious titer assays for intermediates, drug substances and final drug products.
“We see growth potential in the biopharmaceutical space as the technologies to produce these therapies continue to evolve and improve. The expansion was a direct response to growing opportunities with existing clients and to allow the Durham facility to support a greater number of projects and later phases of clinical development for these programs,” Franco tells DDNews.
“We now have a greater allocation of lab space to accommodate the new equipment and have recruited personnel to support the additional capabilities. These changes have enabled the site to offer analytical chemistry and manufacturing controls (CMC) support beyond traditional small molecule therapies including virus, bacteriophage, and exosomes. A new GMP stability suite dedicated to biologic samples has been added to the site,” he added. “The suite features new instrumentation with fully compliant data integrity solutions. New procedures for sample flow and handling have been established to enable the team to support Bio Safety Level (BSL)-2 rated materials in the GMP labs.”
“Customers can take advantage of the additional capabilities that are the best fit for their process. Existing customers can reach out to their Cambrex contact to discuss how we can align to accommodate their needs. New customers can access these services by connecting directly with our experts via the Cambrex business development team,” Franco notes. “We can confidentially discuss any specific project needs and offer a custom solution.”
All of Cambrex’s new capabilities comply with current good manufacturing practice standards and meet International Conference on Harmonization (ICH) Q2 and United States Pharmacopeia guidelines for validating biological assays, as well as ICH Q6B test procedures for biological products. Cambrex says that the existing safety and containment practices for BSL1, BSL2 and some BSL2+ at the Durham site allow support for a wide range of active ingredients.
“As a result of the expansion, the Durham facility is also ready to partner with our clients developing biopharmaceutical therapies by offering standalone analytical services from development to GMP release and stability. The site is well established as a standalone analytical service provider, in addition to early-phase API development and manufacturing,” states Franco. “This expansion has allowed the site to dedicate space for continued growth in support of biopharmaceutical development.”
Ongoing assay additions are planned for Cambrex’s Durham site, including impedance-based orthogonal methods for existing and new cell-based potency assays, and protein-protein interaction/binding assays.
In late March, Cambrex also gained a new team member, appointing Troy Player as president of Early Stage Development and Testing. In his new role, Player has responsibility for operations at the newly expanded Durham site as well as the Agawam, Mass.; Edinburgh, U.K.; High Point, N.C.; and Longmont, Colo., facilities.
“I am pleased to welcome an operational excellence and continuous improvement expert like Troy to our team,” commented Shawn Cavanagh, president and chief operating officer at Cambrex. “He is well versed in leading cross-functional business improvement within commercial, manufacturing, customer service, business development, logistics/procurement, and product management/development environments, which makes him an invaluable asset to our team.”
Player joins Cambrex from West Pharmaceuticals, where he was most recently vice president and general manager of the Contract Manufacturing Business Unit. In that role, Player oversaw six manufacturing locations and two engineering development centers. Prior to that, he served as vice president and managing director for West Pharmaceuticals’ Asia Pacific Region.