The Digitalization Of Biopharmaceutical Process Development And Manufacturing: The 3 Essentials For Industry 4.0

By Wolfram Schulze, Vice President, Information Systems Organization & Digital Transformation, Rentschler Biopharma SE

The fourth industrial revolution, aka Industry 4.0, is coming — in fact, it has already begun. To understand the nature of Industry 4.0 and the process of digitalization as they apply to the pharma industry, this paper differentiates three keys terms that are often used interchangeably: digitization, digitalization, digital transformation.

The three essentials of bioprocess development and manufacturing digitalization that will be explored in this white paper are:

• Digital literacy — The combination of top-down (C-level and senior management level) and bottom-up education; this is the foundation of digital business transformation
• Digital trust — Taking steps to safeguard data and protect intellectual property, effectively extending trusted business relationships into the digital domain
• Prioritization — Deciding on the right order of steps in digital transformation; there are many digital topics that could be tackled in an organization, so what is the best approach for your company?

A thorough understanding of these 3 essentials of digitalization is a prerequisite to success for all industry stakeholders, and contributing to a greater degree of shared knowledge is the goal of this paper. The motivation is simple: By cooperating with one another, the success of all players can be maximized, which will ultimately ensure that life-saving therapeutic products reach the patients who need them.