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
-
A Comprehensive Guide For Supplier Quality Agreements10/29/2024
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.
-
Tracking 4 Payload Trends In Drug Delivery Development1/22/2024
Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.
-
6 PEG Alternatives You Should Be Thinking About11/22/2023
PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.
-
4 Major Trends In Lipid Nanoparticle Research9/7/2023
When biopharmaceutical consultant Alexander Aust noticed a flood of new research on lipid and polymer nanoparticles pouring out of universities, he started collecting it. Soon, his collection grew enough to reveal trends in the research of nanoparticles in oncology, neurology, infectious disease, and, of course, nucleic acids. He provides a quick overview of those trends and the database with links to published research — more than 300 articles published since 2020.
-
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.
-
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.
-
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.