Alexander K. Aust
Alexander K. Aust, M.S., MBA, is the co-founder and owner of Aust Business Solutions, a pharmaceutical consultancy based in Maryville, Tennessee. The firm specializes in the manufacture of cell and gene therapies and sterile, parenteral drug products with services including facility design and construction, corporate strategy, marketing, business development, market research, project management, technology transfers, CDMO selection, quality audits, supply chain management, and process development of drug delivery systems. The firm has helped companies increase capabilities and capacities related to mRNA-LNP formulation, testing, and cGMP manufacturing. The firm has also established and qualified cGMP drug product and biologics facilities that can manufacture preclinical, clinical, and commercial drugs to meet global regulatory requirements. Aust earned his MBA from Ball State University and an M.S. degree from Purdue University in molecular and cellular biology.
ARTICLES BY ALEXANDER K. AUST
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An Independent Expert’s Guide To Picking Nanoparticle Manufacturing Equipment7/26/2023
Until recently, nanoparticle manufacturers had to change equipment between preclinical, clinical, and commercial phases. Advances in technology offer more flexibility allowing manufacturers to turn up the dial on the same machines — from early development all the way to commercialization.
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Draft FDA Labeling Guidance Proposes More Clarity For Providers3/7/2023
The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.
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6 Strategies To Protect Your Biologics Supply Chain In 20231/25/2023
Instead of automating everything — which costs a lot and doesn't solve every problem — drug makers should focus on building scalable, need-specific supply chain operations. This article discusses supply chain resilience strategies biotech companies can reasonably control.