To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route.

The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

Clinical ancillary management expertise helps biopharma company oversee a large, global trial from start through finish.

Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products. The knowledge obtained during development can establish the design space and determine suitable process controls. The novelty of the multivariate approach over the traditional one-factor-at-a-time (OFAT) type of study is the ability to evaluate both the individual factor effects and the factor-factor interactions that can also be significant. In this case study, a QbD approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic.

ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis Fast Dissolve Technology to their therapy, bringing a vastly superior product to market.

Discover how Catalent's oral drug delivery offerings can help get your molecule to market faster. In this case study, learn the many benefits of our product offerings.

Four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation play into the success of a biologic's commercial manufacturing journey.

Process characterization is an important step in the overall journey of product development. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.

Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

Traditionally, new chemicals are developed using batch processing, which fully relies on versatile and qualified equipment to perform different unit operations. To address these challenges, continuous flow chemistry technology is emerging as an effective tool to conduct chemical synthesis.