Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.
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. The overall result was a marked improvement in patient tolerability, preference and compliance.
Tablet land is beneficial to add strength and durability to the punch tip. But, this hand land may be perceived as making it more difficult to coat the tablet.
In this case study, API (X) is a highly insoluble compound with a particle size of approximately 14 microns and targeted as a powder for oral suspension dosage form.
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.
As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.
The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.