Drug Manufacturing and Development in the Age of Precision Medicine
Growing demand for patient-centered healthcare presents fresh challenges for pharmaceutical product development and manufacturing. As precision medicine gains traction in research and development pipelines and the pharmaceutical marketplace, specialist providers are leveraging cutting-edge technologies to offer flexible services and capabilities that address this complex new environment.
There are multiple drivers for health care tailored to individual patients. They include demand for more cost-effective and efficient care in the face of trends such as population aging, associated chronic diseases, and escalating health care expenditure; the growing complexity of disease management, as science continues to unlock the causes, mechanisms and consequences of ill health; increased patient awareness or empowerment, facilitated by digital technologies and media; and opportunities or incentives for patients to take a more active role in managing their own health.
These broader currents are reflected in the emergence of precision medicine, both as a tool for more streamlined, targeted and productive pharmaceutical R&D and as a product platform to ensure that each patient gets the right medicine at the right time, in a format optimized for their needs. Underpinning those efforts are scientific advances ranging from data analytics and biomarkers to genomics and systems biology, as well as novel techniques for enhancing drug formulation and delivery.
Of the 44 therapeutic new molecular entities (NMEs) approved by the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in 2019, 11 or 25% were personalized medicines as defined by the US-based Personalized Medicine Coalition (PMC). The trend was even more pronounced in 2017 and 2018, when the PMC classified 34% and 42%, respectively, of NMEs as personalized medicines.
Section Title: Supporting The Precision Medicine Agenda
CMIC Group is a Pharmaceutical Value Creator and Japan’s largest contract research organization. As a one-stop shop for drug development and manufacturing services, from preclinical and clinical through to commercialization and post-marketing surveillance, it has the experience and agility to handle a broad range of drug formulation, delivery, dosage and presentation requirements. These include powders/granules, capsules, injectables, lipids, semi-solid dosage forms and topical solutions, as well as oral solid formats such as immediate/sustained-release and orally disintegrating tablets (ODTs).
In terms of finished products, solid-dosage forms still account for a large share of the worldwide market for contract development and manufacturing of medicines. That share was 41% in July 2018, according to a breakdown by PharmSource. Nonetheless, there is also a good deal of market diversification.
This reflects, for example, the primacy of injectable dosage forms (27% of the global contract market in July 2018, according to PharmSource) among the more targeted biologicals now dominating the new-drug landscape. But it also underlines the need for alternative formats, such as specialty (21% of the worldwide market) and semi-solid/liquid dosage forms (11%), that favor choice and convenience in addressing the full range of patient needs in a more personalized healthcare environment.
Conducted mainly in Japan and the United States, CMIC’s pharmaceutical-development activities span:
- Pre-formulation research. Physicochemical evaluation, including particle engineering (e.g., micronization) and Good Laboratory Practice supply (manufacturing and stability assessment).
- Formulation and process development. Dry (slugging/roller compaction) and wet (fluid-bed, high-shear) or hot-melt granulation, tableting, encapsulation (active pharmaceutical ingredients, powders, granules and tablets), coatings (particles, tablets).
- Packaging design. Blister packaging, sachets, bottles, clinical-use cards.
- Good Manufacturing Practice (GMP) Supply (~30 kg/sub-batch/250 kg/batch).
- Assay method development/validation, stability testing.
To read more on this rapidly emerging trend, including improving health outcomes, formulating precision medicine, innovations in drug development and manufacturing, microneedles and more, download the full whitepaper.
 Personalized Medicine at FDA: The Scope & Significance of Progress in 2019. The Personalized Medicine Coalition. 21 February 2020.