Maintaining Supply Continuity: 3 Ways to Ease Pharma CMO and CDMO Worries

Supply chain continuity has always been a pressing issue for contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) in the pharmaceutical industry. However, COVID-19’s enduring ripple effects indicate that the severity of supply continuity problems in the CMO contract manufacturing world is rising even as the pandemic appears to be waning. Data from Industry Standard Research’s latest CDMO Benchmarking report show that proportionally more outsourcers suffered negative effects (e.g., manufacturing delays and staff shortages) that led to supply continuity problems in 2021 than in 2020. ¹

Many supply issues are outside the control of pharma CMOs and CDMOs. But if supply continuity problems worsen, cautiously optimistic outsourcing organizations would be wise to find ways to exert greater control over the controllable aspects of their supply chains and general CMO manufacturing activities. These three practical steps will help pharma contract outsourcers exercise greater control over their supplier-related data, interactions, and processes and put them in a better position to cope with supply continuity challenges as they arise.

#1: Enhance Supply Chain Efficiencies by Digitizing Processes

The pharma industry in general — not just the CMO contract manufacturing segment of the industry — has always lagged behind other sectors in adopting advanced digital tools to modernize production and shore up supply chains. When the pandemic turned chronically problematic supply chain issues into major crises, outsourcers hastened their digital transformation efforts and quickly — and out of necessity — started automating and virtualizing processes to maintain viability.

Recently, Contract Pharma asked industry leaders to identify the top CDMO pharma trends of 2022 and beyond. At the top of Pfizer CentreOne Contract Manufacturing Lead Tom Wilson’s list was the uptake and implementation of advanced digital manufacturing and analytical technologies that generate timely insights. “These are the connected, collaborative tools the CDMO industry needs to accomplish increasingly faster development timelines and achieve the stable, secure supply chains that assure patients’ safe, affordable access to pharmaceutical-based healthcare,” Wilson said. ²

#2: Maintain the Consistency and Accuracy of CMO Manufacturing Data by Eliminating Paper

As more digitally savvy, nimble, and lean competitors join the CMO manufacturing fray, it’s getting harder to stay ahead. You can stop wasting time and start gaining an edge by ditching paper-based processes. Paper opens the door for human errors, inaccurate/missing data, siloed knowledge, and process dysfunctions. In fact, manual, paper-based processes are the leading cause of batch release and quality inefficiencies in CMO contract manufacturing, according to Accenture Life Sciences industry surveys. ³

By digitizing batch records, CMO manufacturing outsourcers gain the ability to:

• Simplify interactions and collaborations with suppliers.
• Minimize review times.
• Monitor deviations in real time.
• Deliver products to market sooner.
• Take paper records (and the errors and delays associated with them) out of the equation.

When batch records and other supplier-related records are fully digitized, pertinent data stays connected from beginning to end, without the need for any offline paper processes or manual reconciliation of paper forms. Plus, digitization enables outsourcers to maintain vital supplier-related documentation — from CMO quality agreements to formal policy documents and everything in between — in a centralized repository.

#3: Improve Connectivity and Visibility by Integrating CMO Manufacturing Systems

Just as pharma companies employ an array of systems to manage their outsourcing partners, every pharma CDMO or CMO uses a variety of enterprise systems — enterprise resource planning (ERP) systems, material requirements planning (MRP) systems, and quality management systems (QMS), just to name a few — to manage collaborations with and transfer information between their suppliers.

Tight integration of those core systems allows pharma CDMOs and CMOs to achieve unprecedented levels of connectivity between production and quality across the supply chain. Seamlessly connected systems keep pharma outsourcers and their suppliers on the same page and allow them to:

• Maximize productivity.
• Synchronize data and maintain a single source of truth for supply information.
• Improve right-first-time metrics.
• Directly embed quality into manufacturing processes from square one and throughout the entire product life cycle.

Alleviate Supply Concerns With Modern CMO Manufacturing Tools

The flexible, purpose-built MasterControl Manufacturing Excellence (Mx) solution makes it easier for pharma outsourcers to take each step outlined above by fully digitizing and connecting their operations and processes. You can calculate the potential ROI impact that the advanced Mx system can have on your CMO contract manufacturing activities here.

Resources:

1. “Outsourcers Are Feeling Uneasy About Continuity of Supply,” by Kate Hammeke, Life Science Leader, April 1, 2022.
2. “Pharma & Biopharma Trends CDMOs Face in 2022 and Beyond,” by Tim Wright, Contract Pharma, April 4, 2022.
3. “Dare to Be Different: It’s Time to Revamp Collaboration in Life Sciences Contract Manufacturing,” Anne Marie O’Halloran, Barry Heavey, et al., Accenture Life Sciences, 2019.