Newsletter | August 17, 2022

08.17.22 -- Drug Development: Flexible Dosing For A Diverse Patient Population

Meeting The Need For Flexible Dosing For A Diverse Patient Population

When companies are looking to combine two or more APIs into a single fixed dose combination product — whether for the purpose of improving convenience and patient compliance, reducing manufacturing costs, repurposing proven compounds, or extending a product’s patent life — several factors require consideration. Working with a flexible outsourcing partner with a broad range of capabilities and advanced know-how can provide an advantage.

How Collaborative Value Engineering And Continuous Improvement Enhance The CDMO Relationship

Regular assessments of a partnership’s value in terms of supply chain, operational efficiency, data analysis, and more can optimize and extend the product life cycle. This need is particularly pressing for pharma companies operating in the generics or branded over-the-counter (OTC) spaces, since extending the product life cycle depends on lowering costs in response to competition-driven price pressure.

Reformulating For An Age-Appropriate Dosage Form: Children And Preteen Patients

A global biopharmaceutical company with a successful adult anti-infective product franchise was looking to create a pediatric formulation to meet U.S. FDA regulatory requirements, expand patient access to children in an appropriate dosage form and strength, and extend patent protection of its flagship product line.

Drug Product Development: Developing With Expertise

Specializing in executing all aspects of the CMC dosage form section of the NDA, Cambrex’s laboratories, pilot facilities, and experts are with you at every stage of the development process. Cambrex can take your product through excipient iterations, preformulation and formulation activities, through to the manufacture of clinical trial materials and registration batches.

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