CMC
Manufacturing Framework
We establish the chemical structure, synthesis route, and quality specifications, drawing the “blueprint” for mass production. We connect everything from research to commercial production within an integrated framework.
Craftsmanship
Pharscigen Innovation
At the intersection of traditional formulation technology and advanced science, we propel drug-discovery modalities forward.
The diseases medicine confronts are shifting toward chronic, multifactorial conditions whose causes lie “inside” the body. In this domain, the conventional framework of “one target, one drug” alone struggles to reach a fundamental solution. At the intersection of “Refining” through traditional pharmaceutical technology and “Redefining” through cutting-edge technology, we advance the creation of new medicines unbound by existing frameworks.
Fusing the passion of Pharma with the wisdom of Science to open up the future for the next Generation—we call this “Pharscigen Innovation,” and we continue to take on the challenge of turning an as-yet-unseen “cure” into the common sense of medicine.
Process
Drug Discovery Process
From the discovery of a new drug candidate to its arrival in the world as a medicine, a series of development processes is required. NOVARK BIO is putting in place the framework required at each stage, working toward connecting this series of processes end to end.
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01.
Drug Discovery Research
The stage of selecting the candidate substances that form the basis of a drug’s efficacy.
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02.
Process Development
The stage of exploring routes for stable, efficient synthesis.
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03.
Manufacture of Research-Grade APIs
The stage of manufacturing high-quality APIs for non-clinical and clinical studies and confirming their safety.
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04.
Transition to Commercial Production
The stage of obtaining the data needed for regulatory approval applications and establishing a mass-production framework.
Quality
Quality Management System
CMC, GMP, QC, and QA. Each has its own independent expertise, yet they work together and converge into a single quality. Our principle is that quality is not sorted out by inspection but “built into the manufacturing process.” We assure quality through validation, change and deviation control, and data integrity (rigorous audit-trail management via electronic records).
GMP
Manufacturing Control
We build a system that assures a high level of quality—preventing contamination, quality deterioration, and human error during manufacturing, and delivering consistently the same quality in every production lot.
QC
Quality Control
We handle the analysis of synthetic intermediates and final APIs, judging conformity to specifications—impurities, crystal form, purity, and more—with scientific figures.
QA
Quality Assurance
The “command center” that oversees the entire manufacturing process. From a perspective independent of the manufacturing and testing departments, it makes the final decision on whether a product can be released.