BioPharm International - February 2020

BioPharm-Outsourcing eBook

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24 BioPharm International eBook February 2020 Digitalization: A CDMO's Perspective CDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing. N ew technologies and digital trends con- tinue to drive growth in the possibilities associated with digitalization. As one of the world's most highly reg ulated industries, the pharmaceutical industry is diverse and complex. That is why digitalization in the pharmaceutical industry as compared to other industries began at a later date. And, while the chal- lenges of digitalization within the pharmaceutical industry are similar between different players (i.e., contract manufacturing organizations and marketing authorization holders), there are some special chal- lenges that a contract development manufacturing organization (CDMO) must contend with. What are these challenges and how does a CDMO approach digitalization in general? Consider the following best practices for digitalization for CDMOs. STANDARDIZING PROCESSES A significant benefit of digitalization in the pharma- ceutical industry is making documentation processes both safer and more efficient. Although CDMOs by their very nature differ from their pharmaceu- tical and biotech customers, these differences can be more noticeable when it comes to digitalization. Laboratory testing equipment is one such example because customers, not the CDMO, determine what testing equipment is to be used for a particular anal- ysis. A drug producer can use one type of equipment, but for a CDMO it may be that many different types of equipment are needed for the same kind of testing depending on the customers' choice. The resulting PICKUP - STOCK.ADOBE.COM KAI VOGT is senior vice-president Corporate Development, Legal and Compliance, Information Technology at Vetter Pharma. KAI VOGT Partnerships for Outsourcing Outsourcing

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