review panels, and having helped multiple companies successfully
take their drug products through the review process.
BUILDING QUALITY INTO THE PROCESS
As stated, quality is a top priority for companies outsourcing
small molecule API manufacturing. 3, 7 Quality needs to be built
into a process and product from the ground up. That is the concept underlying the Quality by Design (QbD) approach to process development. Earlier this year, for example, we set up a QbD
lab that allows us to analyze all aspects of a process at laboratory
scale and to identify anything that could be a concern as the process is scaled from gram to kilogram to metric ton scale and could
potentially jeopardize the regulatory filing. Such variables might
include reaction parameters that impact product yield or purity,
genotoxicity data, or factors that affect the environmental impact
of the process. The increased focus on minimizing the environmental footprint of a process and product has fueled growing
interest in green chemistry.
Investment in the infrastructure and technology needed to
develop, define, and implement analytical methods and process
monitoring and control techniques at lab scale is highly worthwhile. You will end up saving time, costs, and valuable resources.
You will also make it possible for your clients to file better regulatory documentation. QbD offers the opportunity to do process
optimization at lab scale, experiment with different solvents and
reagents, identify and suppress or eliminate byproducts and impurities, and establish cost-efficient methods to minimize and
dispose of hazardous waste and other environmental concerns.
Recognizing and responding to the changing needs and demands
of the pharmaceutical industry for outsourcing of API develop-
ment and manufacturing is crucial for a CMO to succeed and
grow in the current competitive marketplace. Keeping abreast of
innovation, advancing technology, and the evolving regulatory
landscape is also essential to maximize product safety and qual-
ity, ensure continuous process improvement capability, and help
clients avoid potential pitfalls and accelerate their path to regula-
tory approval. CP
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quality benchmarking report.” January 2016. Available at www.isrreports.
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outsourcing trends in API development & manufacturing. Amer Pharm
Rev July 2016. Available at www.americanpharmaceuticalreview.com
(Last accessed December 2016).
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5. Walker N. Nice Insight outsourcing trends in 2016. Amer Pharm Rev March
2016. Available at www.americanpharmaceuticalreview.com (Last accessed December 2016).
6. Zhang S, Coutant M, O’Connor D, et al. Early development GMPs for small-molecule specifications: An industry perspective (part V). Pharm Technol
2012; 36( 10). Available at http://www.pharmtech.com/early-development-gmps-small-molecule-specifications-industry-perspective-part-v (Last accessed December 2016)
7. Shanley A. Specialty markets and services drive API growth. Pharm Technology 201640( 3): 26-30.