CordenPharma has seen increased outsourcing activities for formulation development and manufacturing, especially in some niche or specialized technologies (e.g. contained products such as antibiotics, oncology, highly potent, etc.). Due to this higher demand, pharmaceutical customers have moved towards shorter preferred supplier lists for development and commercial manufacturing. To meet the demand, CordenPharma is expanding capacity in all R&D groups, both in terms of personnel and equipment, explains Luca Porcu, Director, Global Small Molecules Platform, CordenPharma International.
CordenPharma provides full-service contract development and manufacturing to customers from early development (Phase I clinical studies) to commercialization. “Spanning from cGMP intermediates to APIs to final drug products, CordenPharma’s integrated supply is especially effective for products in the clinical phase, where customers are looking for more flexible timelines, with preference to managing a unique supplier,” says Mr. Porcu.
To fill the gaps of existing market needs, CordenPharma is investing in new development and commercial capabilities and capacities, including the acquisition of new manufacturing facilities, which are also focused in forward and backward integration.
CordenPharma works closely with customers to provide a comprehensive development plan for all clinical phases to achieve product compliance, quality, and safety. “In addition, a Quality by Design (QbD) approach enables customers to gain robust manufacturing processes that will provide a stable supply throughout the development and commercialization phases, while still meeting their often very aggressive timelines,” he says.
One recent development and manufacturing project involved support in meeting a customer’s market demands for patients to gain or maintain access to their product after a shortage. The project required quick response time and expertise in all related production and regulatory activities. “CordenPharma was selected for our ability to manage on very short notice, with a flexible, dedicated team that successfully provided a documentation package that enabled favorable and fast approval by the relevant health authority,” explains Mr. Porcu. The approval was granted without need of a pre-approval inspection, resulting in an immediate restoration of supply to the customer’s patients.
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