Newsletter | December 15, 2022

12.15.22 -- Diving Into Drug Product Formulation, Development, And Scale-Up

The Advantages And Challenges Of Fixed-Dose Combination Products

Understanding both the significant competitive advantages that fixed-dose combination (FDC) products can offer and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Explore considerations for design, formulation, manufacturing, and analysis.

Scale-Up And Site Transfer Of A Semi-Solid Product For Commercial Launch

Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product. The right CDMO should provide expertise and technology from development through scale-up and manufacturing needed to perform the formulation, engineering, analytical testing, and validation work critical for successful site transfer.

Pediatric Dosage Forms: Reformulation And Development Expertise

The challenges for developing PDFs are numerous and varied and relate to the scale of manufacturing, the complexity of development and reformulation work required to support reduced dosing, a range of doses targeted to different age/weight levels, and often more than one formulation type required to meet the needs of toddlers through adolescents. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing.

Drug Product Manufacturing

From preformulation and clinical supply to commercial drug product manufacturing and packaging, Cambrex delivers your complex dosage forms with expertise. With specialized teams and full-service FDA, EMEA, Health Canada, and DEA (CI-CV) approved facilities, Cambrex is equipped to meet your commercialization needs, manufactured to the highest standards of product quality and regulatory compliance.

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