Samsung BioLogics Advances Perfusion Biomfg; Colorcon Partners for Drug AuthenticationBy
The latest news from CDMOs, CMOs, and suppliers featuring news from Samsung BioLogics, Colorcon and Halix.
Samsung BioLogics Advances Large-Scale Perfusion Technology for Commercial Biomanufacturing
Samsung BioLogics, a contract biologics manufacturer, has successfully performed N-1 (3,000-L) perfusion with an alternating tangential flow (ATF) device to supply a 15,000-liter commercial production process for an undisclosed client in the company’s facility (Plant 3) at its manufacturing site in Songdo, South Korea.
During perfusion mode, ATF works continuously by using hollow fiber membranes to selectively filter growth medium from mammalian cells with alternating flow to return cells to the bioreactor, according to information from the company. A diaphragm pump provides the alternating flow and a low-shear environment to minimize cell damage. The spent growth medium is discharged while fresh growth medium is continuously added to replace the spent medium at the same rate. The fresh medium allows for continued cell growth and higher cell densities, according to information from the company.
Source: Samsung BioLogics
Halix Completes New Biopharmaceutical Drug-Substance Facility in The Netherlands
Halix, a provider of clinical and commercial proteins and viral products, has completed its new 6,700-square-meter GMP facility in Leiden Bio Science Park, Leiden, The Netherlands, for the development and production of biopharmaceutical drug substances.
The new five-level production facility contains a manufacturing line for viral vaccines and viral vectors and a separate manufacturing area with a capacity up to 1,000-liter single-use bioreactors. In addition, lab space is available for process development, analytical development and quality control. All cleanroom areas have a unidirectional process flow and are designed to allow commercial manufacturing of biopharmaceutical products.
The company says it is now able to start production of viral products and protein production will follow soon.
Halix was founded in 2012 as a corporate venture and spin-off of HAL Allergy. Halix and HAL Allergy belong to the family-owned Droege Group AG.
Formulation Development/Drug Product Manufacturing
Colorcon, TruTag Technologies Partner in Drug Authentication
Colorcon, a developer, supplier and provider of technical support of specialty excipients, and TruTag Technologies, a security and technology solutions provider, have partnered to enable on-dose verification technology for drug authentication.
The partnership will combine TruTag’s silica-based microtag authentication technology with Colorcon’s expertise in film coating systems, modified-release technologies and specialty excipients.
Colorcon says the collaboration will see TruTag’s optical barcodes incorporated into existing Colorcon coatings with the microtags verified by either a smart phone application or a proprietary reader. Each silicone dioxide particle is encoded with an optical signature that is manufactured into the microtags without the use of additional additives or markers.
Colorcon says the benefits include addressing the problems of counterfeiting, product diversion, returns monitoring, quality control, and product recalls of pharmaceuticals and nutraceuticals.