Flexible Manufacturing: How to Build Agility Into Your Life Science CDMO Operations

Life science contract manufacturing organizations (CMOs and CDMOs) are under increasing pressure to do more with less and to do it faster. From biopharmaceuticals to combination products and personalized therapies, the product mix is more complex than ever. What does that mean for facilities? Essentially, they must support multiple product types, adapt quickly to shifting production schedules, and maintain quality standards across the board.

Flexible manufacturing is a business imperative in life science contract manufacturing. It's no longer enough to have the right equipment. You also need the right systems, processes, and data visibility to pivot with precision.

In this final installment of our five-part series on contract manufacturing compliance, we're diving into the operational shifts needed to enable manufacturing agility and what it takes to sustain quality and compliance in high-mix environments. You'll also learn how MasterControl's contract manufacturing software helps CMOs and CDMOs meet these challenges more efficiently and confidently without sacrificing traceability or regulatory alignment.

Want to see how leading CMOs and CDMOs are staying flexible and future-ready? Download the guide: Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.

Managing Multi-Product Facilities Without Compromise

It's no small feat to run a multi-product facility. It means managing equipment utilization, cleaning validation, staff training, and material flow with precision. As client expectations grow more sophisticated, contract manufacturers must accommodate a broader range of products. Each product range has unique regulatory, process, and documentation requirements.

This challenge is particularly intense in biologics and personalized medicine, where small-batch production and tight timelines are the norm. Facilities need layouts that support product segregation and efficient resource allocation. Plus, the layouts must be agile enough to shift gears quickly.

The operational complexity of juggling multiple products in varying stages of production demands intelligent infrastructure. From scheduling and maintenance tracking to real-time visibility into production progress, digital tools are critical for streamlining transitions, reducing downtime, and maintaining audit readiness.

Smarter production planning and digital oversight allow manufacturers to adapt in real time without compromising compliance.

Explore how digital transformation supports smart facility management. Download the guide: Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.

How Fast Is Fast Enough? The New Normal in CDMO Turnaround

Today's clients expect faster changeovers between product runs. Downtime is inefficient and costly for your operations and your customers. But speed can't come at the cost of quality. Effective changeover strategies must balance efficiency with traceability, ensuring every step is executed and documented correctly.

Rapid changeover now includes more than swapping out materials. It also involves:

• Cleaning validation and verification.
• Recipe and batch record version control.
• Staff training checks for each product type.
• Equipment readiness reviews.
• Change control and deviation documentation.

Each step must be executed consistently and documented thoroughly to meet regulatory expectations and client standards. As portfolios expand and production cycles shorten, relying on manual or disconnected processes only increases the risk of error and delays.

That's where digital transformation makes a critical impact. MasterControl Manufacturing Excellence (Mx) helps contract manufacturers digitize and standardize these tasks. Real-time checklists, automated alerts, and role-based workflows ensure every step is complete and auditable. Changeovers become repeatable, traceable, and faster without cutting corners or compromising compliance.

Built-in Quality for Every Product, Every Time

Product diversity increases the risk of variability. Each product introduces unique process parameters, raw materials, and compliance needs. For CMOs and CDMOs managing multiple lines, it's critical to ensure consistency.

Modern quality practices in flexible environments include:

• Pre-configured digital templates for batch records and standard operating procedures (SOPs).
• Integration between quality and manufacturing systems.
• Role-based access to protect against unauthorized edits.
• Embedded checks to flag deviations early.
• Real-time performance dashboards to track outcomes.

MasterControl enables this level of consistency. Its connected quality and manufacturing platforms help teams deliver reliable results (even in high-mix, high-velocity environments). That's a clear advantage for sponsors evaluating long-term partnerships.

Let's take a closer look at the results MasterControl helps CMO/CDMO organizations achieve in this case study with Almac Sciences.

Almac Sciences is a leading CDMO based in Northern Ireland known for its high-quality contract pharmaceutical services, which include API production and peptide manufacturing. The organization significantly advanced its manufacturing capabilities by adopting MasterControl's Mx software. Almac faced growing pressure to produce personalized medicines faster and more efficiently. Traditional paper-based systems created delays and bottlenecks, especially in high-mix, low-volume environments.

By implementing Mx, Almac dramatically reduced production cycle times from months to days. The digital platform streamlined and improved:

• Electronic batch records.
• Batch review processes.
• In-line quality control.
• Compliance.
• Audit readiness.

It also enabled real-time collaboration, simultaneous task execution, and flexible workflows, essential for manufacturing individualized cancer vaccines and complex peptides.

Almac's success with Mx has led to faster inspections, higher client satisfaction, and scalable growth. It also positioned Almac to double output without doubling paperwork. Its modern manufacturing execution system (MES) supports evolving regulatory demands while empowering innovation in drug manufacturing. Employees also report greater efficiency and personal fulfillment knowing their work directly impacts patient lives.

Ready to align speed, quality, and compliance? Download the guide: Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.

Mastering Flexibility With MasterControl

Agility comes from the right mindset and the right tools. CMOs need systems that enable fast pivots, clear oversight, and repeatable outcomes. MasterControl's software is purpose-built to support that agility.

By digitizing your operations with MasterControl, you gain cloud-based access to production and quality data. You'll also be able to create custom workflows that match product and client needs. MasterControl reduces paperwork, connects data, accelerates decision-making, simplifies compliance tasks, and improves collaboration across teams and sites.

With built-in analytics and real-time visibility, teams can proactively identify bottlenecks, respond to deviations faster, and continuously improve performance. Whether you're supporting one product line or many, this level of insight helps you maintain operational control without slowing down.

Life science CDMOs and CMOs that embrace flexibility are preparing for what's next. Flexible operations are how you stay competitive and compliant. MasterControl empowers you to move quickly and operate confidently. The result? Smarter processes, less waste, and greater value for your clients.

Ready to set your CDMO up for long-term success? Access the full guide: Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.