From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization
Steve Schweibenz, President, Manufacturing and Analytical Services
Ben Reed, Vice President, Manufacturing
Moderated by Renee Mieras, Senior Marketing Content Writer
The development of pharmaceutical products, in dosage forms that the human body can safely and effectively metabolize, is a challenging undertaking. Selecting a lead candidate for its potential effect on human physiology is only the beginning of the drug development process. The next of many considerations is synthesizing the molecule or compound, and formulating it into a final product for a clinical study.
Initial formulation decisions will take into account the candidate material’s chemical structure, target receptors or pathways, stability, reproducibility, potency, compatibility with excipients, and dosage form (i.e., topical, oral, or injectable). Dosage forms play a key role in targeting specific areas in the body, or aiding in bioavailability of the active pharmaceutical ingredient (API). The material needs to be manufactured for study in a way that is efficient, safe, and cost-effective. Once the drug has completed initial safety testing in vitro/in vivo, and advances to human trials, scalability, blinding, budget, and timelines, become additional important considerations.
Altasciences’ manufacturing and analytical services expertise supports pharmaceutical programs, from formulation development to human trials and commercialization, with a highly trained, knowledgeable workforce and accessible personnel, from project leaders to senior management. Our facilities are ready to take on your most challenging APIs, with potent handling facilities and certified Grade C clean rooms. In this podcast, two of our key manufacturing executives offer a detailed overview of our comprehensive offering:
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Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.