Issue link: https://www.e-digitaleditions.com/i/1483907
10 BioPharm International ® Manufacturing and Facilities 2022 eBook www.biopharminternational.com can flexibly connect with new equipment, instruments, and software as they are deployed in an organization, and some LIMS feature cloud connectivity. Data that are easily transferable and securely hosted in the cloud are unrestricted by physical IT infrastructure, and thus manufacturers can more easily expand capabilities and capacity as technologies and requirements change. Toppling common barriers to Pharma 4.0 progress Despite the benefits of modern LIMS, organizations looking to deploy such infrastructure and attain Pharma 4.0 face several roadblocks. One of the most important is that advanced informatics solutions and Pharma 4.0 transformation can require significant upfront invest- ment. In addition, digital transformation progress can be stymied by cultural inertia within organizations. In- deed, up to 70% of change programs fail due to employee resistance and lack of adequate team support (1). All of this is complicated by the fact that every organization is different, and thus there is no standardized, one-size- fits-all process for ensuring success. Manufacturers can take several steps to simplify the Pharma 4.0 journey and sidestep some of the most common challenges. Understand and clearly communicate the risks of no/late adoption. Many of the challenges noted above, espe- cially the cost of up-front investment, are less paralyz- ing once digital transformation is understood within its proper context: that the pharmaceutical sector is moving quickly, and manufacturers that don't adapt may fall behind. By failing to innovate, organiza- tions risk being outperformed on quality and speed, and can become less attractive to skilled prospective employees. These organizations might also find it in- creasingly difficult to accommodate the manufacture of novel and more complex therapeutic modalities. While not adapting at all can be detrimental for or- ganizational and product success, late adoption can be equally unfavorable. As Pharma 4.0 is realized by more manufacturers, new technologies and processes will be designed and tailored to this paradigm. Companies may thus have no choice but to transform eventually—this time in a more reactive, time-intensive way as they look to catch up with the competition. Adopt a multi-segment change-management approach. To overcome the cultural resistance that can stif le the journey to Pharma 4.0, orga- nizations must prioritize people in their change management plans. In practice, this means orga- nizations should engage and consult with leaders and employees across all levels and job f unctions during planning and decision-making. Then, not only can companies increase trust and visibilit y, but they can also get a clearer picture of the AutomAtion Drug Digest: Sterilization's Horizon: Improving Automation, Single-Use Technologies, and Annex 1 Drug Digest is a tech talk video series with the editors of Pharmaceutical Technology, BioPharm International's sister publication, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products. In this exclusive Drug Digest video interview, Meg Rivers and Felicity Thomas, Pharmaceutical Technology editors, interview experts in sterilization and aseptic processing. Alex Van Hagen of Watson-Marlow Fluid Technology Solutions discusses how to approach selecting sterilization methods, installation of aseptic machinery, how single-use technology factors into aseptic processing, and areas for improved automation. In a quick-fire interview, Hamish Hogg of Cherwell Laboratories talks about the eagerly anticipated publication of the revised EU GMP Annex 1 guidance, potentially problematic aspects of the revised guidance, and tips and tricks for companies to ensure compliance. Dr. Alex Van Hagen is a molecular biologist by training and the current North UK life sciences sector specialist for Watson-Marlow Fluid Technology Solutions. In this position, Alex provides experience-based consultation to the life sciences sector, taking each project from cradle to gate. Hamish Hogg has been the microbiology product specialist at Cherwell Laboratories since January 2019. He has a background as a biomedical scientist for the NHS in microbiology. Visit PharmTech.com/drug-digest for more videos on a variety of bio/pharmaceutical manufacturing topics.