Cell and Gene Therapy Manufacturing: Standardizing the Future of Contract Manufacturing

Cell and gene therapies (CGTs) have a massive impact on the future of medicine. These highly personalized, scientifically advanced treatments promise to cure diseases once considered untreatable. However, as science continues to evolve, so must the manufacturing models that support these therapies. The industry is at a turning point, and for contract development and manufacturing organizations (CDMOs), the call is clear: standardize, scale, and support these transformative therapies through flexible, quality-first approaches.

Yet, there are challenges — and opportunities — that surround this new transformation. At the heart of both lies one truth: the demand for advanced therapies is growing faster than the systems built to deliver them. To remain competitive and relevant, life science contract manufacturing partners must reimagine how they produce, collaborate, and ensure quality — especially in the face of increasingly complex and operational expectations.

Below, you'll learn the top factors shaping the future of cell and gene therapy manufacturing and how embracing digital tools like cell and gene therapy software is the key to future-proofing the industry.

Engineering Manufacturing Systems for CGT Complexity

Unlike traditional biologics or small-molecule drugs, cell and gene therapies are highly individualized. Many are patient-specific and are often manufactured in small batches or even single lots. That creates an enormous logistical and operational burden: custom workflows, strict chain-of-custody controls, cold chain requirements, and fast turnaround times — all while maintaining compliance.

Put simply, it's not just a scale problem; it's a complexity problem. The global cell and gene therapy manufacturing market reflects this complexity. In 2023, the market size was estimated at \$9.95 billion. It is projected to reach \$106.03 billion by 2033 (a CAGR of 26.7%).¹ The growth shows the heightened demand for specialized manufacturing capabilities.

To address these challenges, cell and gene therapy organizations are investing in modular cleanroom designs, single-use systems, and automated equipment. These investments are crucial for accommodating autologous and allogeneic therapies, ensuring flexibility and scalability in production processes.

Read more about the complexities facing the life science industry in MasterControl's e-book "Overcoming 3 Key Challenges Facing Life Science Contract Manufacturers."

Using Strict Collaboration Requirements to Improve Relationships Across Teams

The success of cell and gene therapies hinges on seamless collaboration between therapy developers and manufacturing partners. Unlike traditional pharmaceutical production, where processes are largely standardized, CGT development is deeply iterative and highly dependent on close coordination between innovators and contract manufacturers.

Technology transfer, often a pain point in traditional biologics, becomes even more critical in CGT. Early alignment on process development, raw material selection, and analytical validation can prevent downstream delays. By partnering early, developers can ensure their therapies are not only scientifically sound but also manufacturable at scale.

Transparency and integrated data systems are also vital. In 2023, Deloitte's cell and gene therapy industry survey² found that companies using real-time collaboration platforms saw a 23% reduction in time-to-clinic compared to those using manual coordination methods. Modern cell and gene therapy manufacturers are adopting cloud-based systems that provide live dashboards, secure document sharing, and batch-level visibility — all of which are key to maintaining the chain of identity and ensuring regulatory readiness.

Finally, shared quality ownership helps build stronger partnerships. Rather than a transactional approach, sponsors and CDMOs are increasingly co-developing quality frameworks, training together, and defining critical quality attributes (CQAs) upfront. The 2022 Alliance for Regenerative Medicine report³ highlighted that such shared accountability reduces deviations and strengthens compliance, especially as therapies move from clinical to commercial stages.

Discover additional methods CDMOs are using to future-proof collaboration and maintain relationships in MasterControl's guide: Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.

CGT Quality Control Challenges: Upholding Standards Amid Rapid Growth

As the pace of cell and gene therapy manufacturing accelerates, so does the complexity of maintaining rigorous quality standards. From vector design to fill-finish operations, every step in the CGT process introduces unique risks. These therapies are highly sensitive to environmental conditions, raw material variability, and minor process deviations — making consistency not just a regulatory requirement but a matter of patient safety. Yet, many CDMOs and therapy developers still struggle with fragmented or outdated quality systems.

The consequences of even small quality lapses are significant. A single out-of-specification result can delay treatment delivery, jeopardize clinical trial timelines — or worse, lead to discarded patient material. Additionally, continued reliance on paper-based or siloed digital systems creates bottlenecks in batch release, makes audit trails difficult to maintain, and opens the door to transcription errors. For instance, a simple mistake such as misrecording a temperature reading by one decimal point — say, entering 5.0°C instead of 50.0°C — can render an entire batch noncompliant, triggering costly investigations and production delays. MasterControl found that 67% of life science organizations that use paper-based processes had directly contributed to delays in product release or regulatory filings.

Read MasterControl's full industry report here.

Modern, digital quality management systems (QMS) that are purpose-built for life science contract manufacturing offer a path forward. These platforms provide automated deviation tracking, streamlined corrective action/preventive action (CAPA) processes, and real-time audit readiness — ensuring that every lot is documented, traceable, and compliant. For CGT, where speed and precision must go hand in hand, digitizing quality is no longer a luxury — it's a necessity.

Using MasterControl for Simplified, Streamlined Therapy Manufacturing

With the growing complexities of the CGT industry, solutions like MasterControl's cell and gene therapy software are instrumental in streamlining manufacturing processes. Our comprehensive platform includes tools designed to meet the unique demands of cell and gene therapy manufacturing — from early development through the commercial side.

MasterControl's platform includes:

• Electronic Batch Records (EBR): Streamlining batch review and release with automated calculations and real-time status tracking.
• Integrated QMS: Managing deviations, CAPAs, audits, and training in a centralized system to enhance compliance.
• Scalable Document Control: Centralizing standard operating procedures (SOPs), work instructions, and change controls for efficient collaboration and audit readiness.
• Real-Time Dashboards and Analytics: Facilitating data-driven decisions, tracking key performance indicators, and reducing lead times.

With MasterControl, CDMOs can standardize processes, enhance sponsor collaboration, and support digital-first manufacturing strategies.

Want to learn how to stay ahead in the evolving landscape of life science contract manufacturing? Discover the top trends shaping cell and gene therapy manufacturing in 2025, including digital transformation, regulatory developments, and workforce innovation. Download MasterControl's e-book: Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends.

Resources:

1. "Cell and Gene Therapy Market Size to Reach USD 97.33 Bn by 2033," BioSpace.
2. "2023 cell and gene therapy industry survey," Deloitte.
3. "Regenerative Medicine: The Pipeline Momentum Builds," Alliance for Regenerative Medicine.