Lonza, Noramco, Schott, Almac, and PCI Pharma Services ExpandBy
A roundup of the latest expansions and investments from suppliers, contract development and manufacturing organizations and contract manufacturing organizations, featuring news from Lonza, Noramco, Schott, Almac, and PCI Pharma Services.
Chemicals/Chemical API Manufacturing
Lonza Expands High-Potency API Capacity; Opens Line for Clovis Oncology
Lonza plans to expand its highly potent active pharmaceutical ingredient (HPAPI) capacity with the creation of two new manufacturing suites at its site in Visp, Switzerland for manufacturing antibody drug conjugate (ADC) payloads.
Separately, Lonza has also opened a new, dedicated production train at its Visp site for Clovis Oncology’s Rubraca (rucaparib), an US- and European Union-approved drug for several ovarian cancer indications. The new facility features several technologies, including automation and on-line analytical monitoring designed to enable real-time release testing.
Noramco Adds Capacity, Dual Sources of Supply for Cannabinoids
Noramco, a Wilmington, Delaware-headquartered producer of specialty active pharmaceutical ingredients, is adding commercial-scale capacity of dronabinol (THC) at its Athens, Georgia facility. Noramco says the expansion is in response to demand for its highly pure cannabidiol (CBD) and THC analogs of cannabis sativa.
Following implementation, Noramco will supply both THC and CBD from facilities in the US and Europe. Clinical samples will be available from the Athens site in 2018, with commercial production commencing in the first quarter of 2019. Both dronabinol in oil and dronabinol in ethanol are available in Athens. Previously, the company produced these products only in Europe.
Schott Partners for Glass Integrity in Pharma Packaging
Schott, a provider of pharmaceutical packaging, and Smart Skin Technologies, a pharmaceutical packaging specialist, have partnered to improve glass integrity in pharmaceutical packaging with Big Data. Smart Skin has developed an online monitoring system for measuring line pressure and 3D orientation of glass packaging during the filling process of pharmaceutical drugs. This is designed to help pharmaceutical companies reduce packaging defects, such as scratches and bruises in the glass, as well as particle generation.
Almac Expands North Carolina Facility
Almac Group, a Craigavon, UK-based contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs) and drug products, has opened a 24,000-square-foot building at its Durham, North Carolina campus as an investment in its Clinical Services’ and Diagnostic Services’ capabilities. The additional capacity complements Almac’s existing Durham facility, which offers a range of end-to-end clinical trial supply solutions, as well as Almac Diagnostic Services, which provides biomarker-driven clinical trial solutions.
Source: Almac Group
PCI Completes New Facility for Clinical Trial Returns
PCI Clinical Services (PCI), part of PCI Pharma Services, a contract development, manufacturing, and packaging organization, has completed a dedicated returns management facility at its Clinical Services Center of Excellence in Bridgend, UK. PCI offers a full service returns management service for clients to provide visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study.
Source: PCI Clinical Services