Scaling Pharma Manufacturing: What Leading CDMOs Are Doing Differently in 2026

The role of the CDMO has changed dramatically over the past few years.

Today’s pharmaceutical manufacturers are asking more of their CDMO partners than ever before. The relationship is shifting beyond outsourced capacity, with CDMOs increasingly serving as strategic manufacturing partners – a shift reflected in Eli Lilly and Resilience’s recent $750 million investment to expand their manufacturing partnership in Ohio.

Beyond capacity, sponsors expect expertise in advanced therapies, faster tech transfer, greater operational transparency, and the ability to scale programs without compromising quality or compliance. At the same time, CDMOs are managing increasingly diverse product portfolios, expanding into new modalities, operating across multiple sites, and navigating growing validation and regulatory complexity.

As a result, the organizations pulling ahead aren’t simply adding more manufacturing capacity – they’re rethinking how they operate.

The leading CDMOs are building scalable operating models that enable them to onboard new customers faster, manage increasing complexity, deliver greater visibility, and prepare for commercial manufacturing from the very beginning.

In this article, we’ll explore six strategic shifts that are helping leading CDMOs scale more effectively.

In this article, we’ll cover:

1. Design for Complexity, Not Capacity
   Why leading CDMOs are rethinking operations to handle increasing product, process, and customer complexity – not just expanding manufacturing capacity.
2. Standardize the Manufacturing Platform, Not the Customer
   How the most successful organizations create standardized digital and quality foundations while preserving the flexibility each customer requires.
3. Make Tech Transfer a Repeatable Capability
   Why repeatable tech transfer processes are becoming essential for reducing onboarding time, minimizing operational risk, and supporting long-term growth.
4. Manufacturing Data Has Become Part of the Customer Experience
   How increasing expectations for transparency, electronic records, and manufacturing visibility are changing the relationship between CDMOs and their customers.
5. No Paper from Day One
   Why leading organizations are investing in digital manufacturing early to avoid operational bottlenecks as they grow.
6. Build for Commercial Scale from Day One
   How decisions made early in a manufacturing program can reduce future complexity, accelerate commercialization, and create a stronger foundation for long-term growth.

1. Design for Complexity, Not Capacity

For years, pharmaceutical manufacturing growth was largely defined by one metric: capacity. As demand increased, CDMOs expanded facilities, added production lines, and invested in equipment to manufacture more products.

Today, capacity is only part of the equation.

As CDMOs expand into advanced modalities such as cell and gene therapies, RNA therapeutics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and specialized fill-finish operations, they’re also managing more sponsors, more manufacturing processes, more technology transfers, and more regulatory complexity than ever before. At the same time, sponsors are facing their own market and supply pressures, increasing expectations for speed and production readiness. Every new program brings unique recipes, documentation, quality requirements, and validation activities that must be executed consistently and compliantly. 

In other words, growth today is no longer just about producing more batches – it’s about managing significantly more complexity.

Complexity Is Becoming the New Growth Constraint

Unlike traditional manufacturers producing the same product repeatedly, CDMOs operate in an environment where every new customer brings a different set of manufacturing requirements.

One program may involve a cell therapy process, while the next requires an entirely different workflow, quality documentation, or accelerated production timeline.  As organizations expand across multiple sites or add new therapeutic modalities, that variability compounds, making it increasingly difficult to maintain operational consistency without slowing execution.

The CDMOs scaling most successfully recognize that operational complexity – not manufacturing capacity – is increasingly becoming the factor that determines how efficiently they can grow.

Common Mistake Many growing CDMOs respond to increased demand by expanding capacity before redesigning the operational processes needed to support greater complexity. The result is often predictable: more products, more customers, and more sites create bottlenecks in technology transfer, batch review, training, quality oversight, and cross-functional coordination long before manufacturing space becomes the limiting factor.

More Capacity Isn’t Always the Answer

Rather than reacting to complexity by adding more capacity, leading CDMOs are looking first at how effectively they’re using what they already have.

That means unlocking more value from three critical assets: people, systems, and equipment.

They’re creating repeatable processes that help teams work more efficiently, getting more from existing technology, strengthening quality systems, and improving cross-site consistency. The goal is to increase what the existing operation can support before adding more people, equipment, or manufacturing space.

This shift is redefining what operational excellence looks like in pharmaceutical manufacturing. Increasingly, the organizations that scale most effectively aren’t simply those with the largest facilities – they’re the ones that can absorb complexity without compromising speed, quality, or compliance.

What Leading CDMOs Do Differently

• Optimize existing people, systems, and equipment before simply adding more capacity.
• Design operating models that scale with increasing product, sponsor, and regulatory complexity – not just production volume.
• Build repeatable operational processes that reduce friction as new programs are introduced.
• Invest in scalable quality and digital foundations that support long-term growth.

Explore further: Why More Capacity Isn’t Always the Answer for Growing CDMOs.

2. Standardize the Platform, Not the Customer

One of the biggest misconceptions about scaling a CDMO is that growth requires standardizing every manufacturing process.

In reality, the opposite is true.

Every sponsor has unique products, manufacturing processes, quality requirements, and commercialization goals. Attempting to force every program into the same workflow creates unnecessary friction and can limit the flexibility that customers value most.

The most successful CDMOs understand that the goal isn’t to standardize the customer’s process – it’s to standardize the operational foundation that supports it.

Standardize What Shouldn’t Change

Leading organizations distinguish between the elements that should remain consistent across every manufacturing program and those that should remain flexible.

Core GMP operations such as quality management, data integrity, training, change control, and batch review benefit from standardized approaches because they improve consistency, simplify compliance, and reduce operational risk. 

For CDMOs with MES or EBR in place, flexibility needs to be built into the manufacturing layer. Recipes, process parameters, sponsor reporting requirements, and product-specific workflows will vary from program to program. The goal is to accommodate that variability without rebuilding the underlying digital manufacturing environment for every new engagement. 

Configure Rather Than Customize

As CDMOs bring on new customer programs, the difference between configuration and customization can become a hidden barrier to growth.

Rather than building a new recipe design for every customer, leading CDMOs create robust, flexible recipe templates that can accommodate variations in products, processes, and customer requirements. New recipes can then be configured from that foundation rather than authored or customized from scratch.

The result is faster onboarding. CDMOs can get new customer recipes and variations running faster without the heavy lift of designing and validating an entirely new approach each time.

Common Mistake Many growing CDMOs assume that more customers and production automatically require more MES recipes, more MES engineers, and more resources. But with well-designed, templated recipes, much of that additional complexity can be handled within the existing MES framework. New customer requirements and recipe variations can be configured from established templates rather than built from scratch — allowing CDMOs to support more business without adding resources at the same rate.

Flexibility Requires a Strong Foundation

CDMOs that know how to leverage technology don’t have to choose between standardization and flexibility — they can build both into their approach to scaling production as they onboard more customers.

By standardizing the underlying platform while allowing product- and sponsor-specific processes to be configured, they can support faster onboarding, more consistent execution, easier technology transfer, and greater operational resilience as the business grows.

This balance between consistency and flexibility becomes even more important as CDMOs support more sponsors and manage increasingly diverse manufacturing portfolios.

What Leading CDMOs Do Differently

• Standardize quality systems, data, training, and core operational processes — not every manufacturing workflow.
• Configure validated platforms to support different products and sponsor requirements instead of creating custom solutions.
• Preserve the flexibility sponsors expect while creating an operational foundation that can support growth without resources and complexity increasing at the same rate.

Explore further: The CDMO Scaling Challenge: Standardize the Platform, Not the Customer.

3. Make Any Tech Transfer a Repeatable Capability

For growing CDMOs, technology transfer is no longer an occasional milestone — it’s a core business capability.

As sponsors increasingly rely on CDMO partners to accelerate clinical development and commercialization, CDMOs are expected to onboard new products quickly while maintaining quality, compliance, and customer requirements. Whether transferring a process from a sponsor, scaling from clinical to commercial manufacturing, or replicating production across multiple sites, the ability to execute technology transfers efficiently has become a competitive advantage.

CDMOs that do this well don’t treat each transfer as a completely new project. They build robust processes that reduce variability, preserve manufacturing knowledge, and strategically plan for future requirements.

Why Future Requirements Matter

A recent example underscores what can happen when manufacturing capabilities and product requirements don’t align. In August 2026, Bristol Myers Squibb ended its manufacturing partnership with Cellares after determining that Cellares’ automated Cell Shuttle platform could not meet the requirements necessary to manufacture commercial Breyanzi, BMS’s approved CAR-T therapy.

While the specific requirements behind the decision have not been disclosed, the situation highlights a broader challenge for CDMOs: a manufacturing approach that works for one program or stage of development may not automatically support another.

That makes anticipating future requirements an important part of technology transfer. CDMOs need enough flexibility in their processes, systems, and manufacturing templates to accommodate known variability – and a structured way to introduce new requirements without rebuilding the operation each time.

Repeatability Reduces Risk

Every technology transfer introduces new documentation, manufacturing processes, quality requirements, equipment configurations, training needs, and reporting requirements.

Without a structured approach, valuable knowledge often lives in spreadsheets, paper documents, or as “tribal knowledge” held by individual team members. That makes every transfer slower, increases the risk of errors, and creates unnecessary work for manufacturing and quality teams.

Leading CDMOs focus on capturing that knowledge in standardized, repeatable processes that can be reused across programs. This includes manufacturing system recipes that capture proven process requirements and provide a robust starting point for future programs. Rather than reinventing workflows for every new customer, teams can build from established approaches, adapting them as customer and process requirements change.

Digital Foundations Accelerate Knowledge Transfer

As manufacturing programs become more complex, digital execution plays an increasingly important role in making technology transfer repeatable.

Electronic batch records, standardized workflows, and centralized manufacturing data help organizations capture process knowledge from the beginning, making it easier to train operators, support validation activities, and transition products between development, clinical manufacturing, and commercial production.

This becomes especially valuable as organizations grow across multiple sites, where consistent execution depends on reliable access to the same manufacturing information – not individual experience or paper documentation.

Common Mistake Many organizations still approach technology transfer as a one-time implementation project. While that may work for an individual program, it becomes increasingly difficult to sustain as the number of sponsors, products, and manufacturing sites grows. Without repeatable processes and centralized knowledge, every new transfer starts from scratch, slowing onboarding and increasing operational complexity.

Repeatability Creates a Competitive Advantage

The most successful CDMOs recognize that technology transfer is more than a technical exercise – it’s an organizational capability that directly impacts speed, quality, and customer confidence.

The distinction is how that repeatability is achieved. Rather than relying on paper-based procedures or rebuilding each transfer from previous documentation, leading CDMOs create a templatized approach driven by defined parameters. Teams can start from a proven manufacturing framework, configure the variables that change for each product or sponsor, and preserve the knowledge gained for the next transfer.

This makes technology transfer more than a process teams know how to repeat. It becomes a scalable capability that can be executed consistently as new products, sponsors, and requirements are introduced.

What Leading CDMOs Do Differently

• Design technology tools to make tech transfer a core organizational capability, not a one-time design effort.
• Capture and reuse manufacturing knowledge rather than relying on individual expertise or tribal knowledge.
• Use digital template workflows and centralized manufacturing data to accelerate onboarding while reducing cost and risk.
• Build parameter-driven transfer processes that can adapt across products, sponsors, and manufacturing sites without starting from scratch.

Explore further: How CDMOs Can Make Technology Transfer a Repeatable Capability

4. Manufacturing Data Has Become Part of the Customer Experience

Not long ago, sponsors primarily evaluated CDMOs on their ability to manufacture high-quality products compliantly and on time.

Today, those expectations have expanded. Data itself has become part of the deliverable.

Sponsors increasingly expect greater visibility into manufacturing operations, faster access to production information, and complete electronic documentation packages that can support review, release, regulatory submissions, and certification. That expectation reflects a broader shift across the industry toward electronic regulatory information and more readily accessible manufacturing records. FDA, for example, requires specified regulatory submissions to be provided electronically and generally expects records requested during remote regulatory assessments to be submitted electronically.

For CDMOs, this means manufacturing data can no longer be treated as an afterthought assembled once production is complete. The ability to deliver the right data, in the right package, at the right time can directly affect how quickly a sponsor moves a product through review, release, and certification.

For leading CDMOs, delivering transparency is becoming an important part of delivering the product itself.

Visibility Builds Confidence

As pharmaceutical manufacturing becomes more complex, sponsors increasingly rely on accurate manufacturing data to establish confidence that their products are progressing as expected.

That means timely access to manufacturing records, production status, quality information, and batch documentation throughout the manufacturing lifecycle — sometimes in real time. Rather than waiting until production is complete, sponsors increasingly expect accurate, reliable information that helps them make faster, more informed decisions.

Providing timely data with strong data integrity strengthens collaboration, reduces risk, and helps build long-term customer relationships.

Better Data Supports Better Decisions

Manufacturing data creates value far beyond compliance.

When information is captured electronically and made available in a consistent format, manufacturing, quality, and operations teams can identify trends, resolve issues more quickly, improve batch review processes, and continuously optimize operations.

The same data that helps internal teams improve performance also enables sponsors to gain greater confidence in manufacturing execution, creating a stronger partnership built on transparency and trust.

Common Mistake Many organizations still view manufacturing data primarily as documentation for regulatory inspections or historical recordkeeping. Leading CDMOs recognize that manufacturing data is also a strategic asset. Strong data integrity practices — including ALCOA principles that ensure data is attributable, legible, contemporaneous, original, and accurate — help establish confidence in the information being shared. When that data is also accessible and available in real time, it improves operational decision-making while giving sponsors the visibility they increasingly expect from their manufacturing partners.

Transparency Is Becoming a Competitive Advantage

As sponsor expectations continue to evolve, transparency is becoming an important differentiator.

Organizations that can provide timely manufacturing insights, electronic documentation, and greater operational visibility are better positioned to strengthen customer relationships, accelerate review processes, and support faster decision-making throughout the product lifecycle.

Increasingly, sponsors aren’t just selecting a CDMO based on manufacturing capability—they’re also evaluating how effectively that organization communicates, shares information, and supports collaboration.

What Leading CDMOs Do Differently

• Treat manufacturing data as a strategic asset, not just a compliance requirement.
• Provide sponsors with greater visibility into manufacturing execution and product status.
• Use electronic manufacturing records to improve collaboration, accelerate review, and support better decision-making.
• Recognize that transparency is becoming an important competitive differentiator.

Explore further: The CDMO Data Advantage: Building Sponsor Confidence Beyond the Batch

5. Build Your Digital Foundation from Day One

One of the biggest decisions a growing CDMO can make isn’t which digital technologies to adopt — it’s when to adopt them.

Many organizations delay digital transformation until paper-based processes, disconnected systems, or manual workflows begin slowing operations. While that approach may seem practical in the short term, the problem compounds as the business grows. Each new batch, deviation, manual record, and workaround adds another layer of complexity that will eventually need to be addressed.

Like putting one band-aid over another, temporary fixes may keep operations moving, but they don’t solve the underlying problem. The longer a CDMO waits to establish its digital foundation, the more disruptive and costly that transformation can become.

Leading CDMOs take a different approach. They establish a digital foundation early, allowing their operations to scale on a platform designed for consistency, compliance, and long-term growth.

Growth Magnifies Operational Gaps

Manual processes can often support a small number of manufacturing programs. The challenge is what happens as the operation grows.

As CDMOs add new sponsors, products, manufacturing lines, and facilities, they also take on more batches, deviations, documentation, and evolving GMP requirements. Paper records, disconnected spreadsheets, manual reviews, and inconsistent processes become increasingly difficult to sustain.

The problem compounds. More complexity requires more staff hours. Teams create workarounds to keep production moving. Experienced employees become increasingly important because critical knowledge lives with them rather than within the manufacturing system. And when those employees leave, that tribal knowledge can be difficult to replace.

Over time, what began as a manageable manual process can become an operational and compliance risk — increasing the potential for errors, delayed reviews, audit findings, and regulatory observations.

Building the digital foundation early changes that trajectory. Standardized digital workflows capture manufacturing knowledge within the process, enforce GMP requirements at the point of execution, flag exceptions earlier, and reduce the manual effort required as production grows. Instead of adding another workaround each time complexity increases, CDMOs can scale on a consistent foundation designed to accommodate new products, sponsors, and sites.

Digital Supports More Than Compliance

Digital manufacturing is often associated with electronic records and regulatory compliance, but its value extends into how efficiently and consistently the entire manufacturing operation runs.

A strong digital foundation creates standardized workflows, improves collaboration across departments, reduces manual effort, and supports faster batch review. It gives teams greater visibility into manufacturing as it happens, helps identify issues earlier, and makes critical process knowledge available beyond the individuals who hold it.

It also creates a consistent platform that makes it easier to onboard new products, train employees, and expand across multiple sites.

Rather than solving one operational challenge at a time, digitalization provides the infrastructure needed to support continued growth without adding the same level of operational complexity, manual effort, and risk.

Common Mistake Many organizations wait until growth exposes the limitations of paper-based or disconnected processes before investing in digital manufacturing. But the problem compounds. Each new batch, deviation, and GMP requirement adds more manual work, workarounds, and reliance on tribal knowledge — increasing operational and compliance risk as the organization grows.

Digital-First Organizations Scale More Confidently

The most successful CDMOs don’t view digital manufacturing as a future initiative or an IT project.

They recognize it as a core operational capability that enables consistent execution, supports compliance, improves visibility, and creates the flexibility needed to grow with confidence. The digital system does more of the heavy lifting — embedding best practices into execution, managing risk, and taking lower-level decision-making out of manual operations. 

Building that foundation early doesn’t just make today’s operations more efficient – it positions the organization to adapt more easily as customer expectations, manufacturing complexity, and regulatory requirements continue to evolve.

What Leading CDMOs Do Differently

• Invest in digital manufacturing before growth makes it a necessity, capturing efficiency and scalability gains early rather than trying to fix operational complexity later.
• Replace manual, paper-based processes with standardized digital workflows that reduce manual effort and create repeatable processes across products and sites.
• Build a consistent digital operating foundation that improves visibility, collaboration, compliance, and the ability to manage increasing manufacturing complexity.
• Treat digitalization as a business strategy, not simply a technology initiative, enabling growth without increasing operational burden, staffing requirements, and risk at the same rate.

Explore further: The Cost of Waiting: Why Growing CDMOs Need a Digital Foundation Early

6. Build for Commercial Scale from Day One

The decisions made early in a manufacturing program often have the greatest impact on long-term success.

Whether supporting an emerging biotech company or preparing a product for commercialization, today’s choices around processes, quality systems, digital infrastructure, and operational workflows can either enable future growth or create obstacles that become increasingly difficult to overcome.

Leading CDMOs recognize that commercial readiness doesn’t begin when demand increases – it begins with the operational foundation they build from the start.

Think Beyond Today’s Manufacturing Needs

Early-stage manufacturing often focuses on speed, flexibility, and getting products into the clinic as quickly as possible.

While those priorities are essential, it’s equally important to consider how today’s decisions will support tomorrow’s growth and the requirements of future customers. As products move toward commercialization, manufacturing volumes increase, regulatory expectations evolve, and operations become more complex. At the same time, new customers bring unique processes, manufacturing requirements, and expectations that CDMOs must be prepared to accommodate.

Organizations that plan for both commercial scale and future customer requirements are better positioned to grow, onboard new programs, and adapt without disrupting existing operations.

Future-Proof Your Operations

Preparing for commercial manufacturing isn’t about predicting the future. It’s about building an operating model that can adapt as the business grows and new customer requirements emerge.

That includes establishing repeatable processes, creating consistent quality systems, investing in scalable digital infrastructure, and capturing manufacturing knowledge in ways that support expansion across products, facilities, and teams.

The goal is to standardize the operational foundation while maintaining the flexibility to accommodate each customer’s unique requirements.

This allows CDMOs to onboard new programs more efficiently, adapt to changing manufacturing needs, and give sponsors greater confidence in their ability to deliver.

Common Mistake Many organizations make short-term operational decisions based on today’s needs alone. As they grow, those same decisions often require expensive rework – whether replacing paper-based processes, rebuilding workflows, retraining teams, or implementing new systems while supporting active manufacturing programs. Planning for commercial scale early helps avoid these disruptions and creates a smoother path to long-term growth.

Operational Excellence Is a Long-Term Strategy

The most successful CDMOs understand that scalable growth isn’t achieved through a single investment or technology implementation. It’s the result of consistently making decisions that support future expansion while maintaining quality, compliance, and operational agility.

The goal is to build capabilities that can evolve with the business, rather than investing in individual features or functions to address immediate needs.

Organizations that design for complexity, balance standardization with flexibility, make technology transfer repeatable, embrace manufacturing transparency, and establish digital foundations early are better equipped to meet evolving sponsor expectations and compete in an increasingly complex pharmaceutical manufacturing landscape.

What Leading CDMOs Do Differently

• Build for capabilities, not individual features or functions, creating an operational foundation that can adapt to future customer and manufacturing requirements.
• Make operational decisions with future commercial growth in mind, anticipating changing production volumes, products, and sponsor needs.
• Establish scalable processes and digital foundations early, before complexity makes transformation more difficult.
• Avoid short-term fixes that create long-term operational constraints, prioritizing flexibility and scalability.
• Treat operational excellence as a continuous strategy, supporting sustainable growth rather than a one-time improvement initiative.

Explore further: Why CDMOs Need to Plan for Commercialization from Day One

The Future of CDMO Manufacturing Starts with How You Operate

The CDMO landscape is evolving rapidly. New therapeutic modalities, growing sponsor expectations, and increasing operational complexity are changing what it takes to scale successfully.

The organizations leading the industry aren’t simply investing in more capacity. They’re building operational foundations that allow them to manage complexity, standardize what matters, accelerate technology transfer, provide greater transparency, and prepare for commercial growth from the very beginning.

At POMS, we’ve spent nearly four decades working exclusively with pharmaceutical manufacturers and CDMOs. Because we were born from pharma – not adapted to it – we’ve had the opportunity to see how manufacturing organizations evolve from early clinical production to global commercial operations. Along the way, we’ve seen the operational strategies that consistently separate organizations that scale successfully from those that struggle with increasing complexity.

We help our customers build those foundations through purpose-built Manufacturing Execution System (MES) solutions that support compliant, scalable manufacturing. Whether you’re evaluating your digital manufacturing strategy, planning a facility expansion, or preparing for commercial scale, taking a step back to assess how your operations will support future growth can pay dividends for years to come.

If you’re exploring how to build a more scalable manufacturing operation – or simply want to compare notes on the operational challenges facing today’s CDMOs – we’d be happy to share what we’ve learned from partnering with pharmaceutical manufacturers around the world.

👉 Contact POMS to start the conversation.