In the BioPharma industry, the role of contract development and manufacturing organizations (CDMOs) has grown significantly over the past few decades. According to the latest research, the global CDMO market was valued at approximately $160 billion in 2023 and is expected to expand at a CAGR of 7.2%, reaching roughly $332 billion by 2033.¹ These specialized organizations play a crucial role in developing and manufacturing biological and pharmaceutical products, providing time-saving, cost-effective, and creative solutions to innovative companies.

However, the seamless operation and growth of CDMOs are not possible without the support and collaboration of various stakeholders. Among those stakeholders, Engineering, Procurement, Construction Management, and Validation (EPCMV) firms engage CDMOs as key partners to provide optimized manufacturing solutions and enable the growth of CDMO facilities and operations.

This article explores the critical services EPCMV firms provide when partnering with CDMOs and how this collaboration benefits the BioPharma sector. These innovative services empower CDMOs to deliver high-quality products to the market and, ultimately, the patients.

Importance of CDMOs in the biopharma industry

Before discussing how EPCMV firms support CDMOs, it is essential to understand the significance of CDMOs in the BioPharma sector. CDMOs are specialized service providers offering various services, including product development, formulation, analytical testing, and manufacturing.

CDMOs are vital for several reasons:

• CDMOs provide scalability and agility to BioPharma companies. CDMOs can quickly adjust production capacities to meet the ever-changing market demands. This is particularly crucial in the BioPharma industry, where clinical trial materials, small-batch manufacturing, and large-scale production requirements can vary significantly.

• CDMOs provide a strategic advantage in commercial products. In early February 2024, the acquisition of CDMO Catalent positioned Novo Nordisk to match supply with demand of the $25-30 billion/year GLP-1 market. For start-up companies, an innovator may have a small or no cGMP manufacturing space. Innovator companies partner with CDMOs to scale up and manufacture their new product for cGMP clinical studies.

• CDMOs bring expertise and specialized capabilities that innovator companies may lack. CDMOs often invest in cutting-edge technology, equipment, and highly skilled personnel, enabling them to tackle complex development and manufacturing challenges for innovators. This expertise is critical in accelerating the product development process and ensuring regulatory compliance.

• CDMOs help BioPharma companies reduce costs and risks. By outsourcing certain product development and manufacturing aspects to CDMOs, innovator companies can focus on their core competencies: research and development. This allows them to operate more efficiently and allocate resources more effectively.

CDMOs are integral to the BioPharma industry’s success. They enable companies to bring new products to market faster, with high quality and cost-effectiveness. However, to perform these functions optimally, CDMOs rely on the support of various partners. EPCMV firms are a crucial ally in this journey.

EPCMV firms create solutions for CDMOs

EPCMV firms create solutions and bring expertise to the table. They are responsible for the design, construction, and validation of BioPharma facilities, ensuring that these facilities meet the stringent regulatory requirements of the industry. CDMOs usually do not have large engineering organizations experienced in designing and delivering new facilities or making significant modifications to existing facilities. Also, many CDMOs are young, budding start-up companies with lean staff focused on creating the organization, not building, and designing a facility.

Here’s a closer look at how EPCMV firms help CDMOs:

1. Facility Design
CDMO facilities must be flexible in their support processes and how rapidly they can transition to the following product/process. A CDMO’s facility may need to support a product portfolio including mRNA, DNA, ATMP, ADC, CGT, Mab, viral vectors, cell banking, and recombinant proteins products all under the same roof. An EPCMV company that understands these cutting-edge, unique platforms provides expertise in navigating the operational, equipment, and regulatory challenges and delivering a robust cGMP-compliant multi-use manufacturing facility.

An EPCMV team supports a CDMO by developing strategic CAPEX and facility master plans early in the concept phase and implementing a phased construction/upgrade project execution approach. EPCMV firms provide CDMOs with recommendations on current industry strategies to integrate digitization into their facilities and empower CDMOs to use data analytics to streamline processes, increase operational visibility, and improve decisions on resource allocation to optimize their operations, all while maintaining quality compliance.

EPCMV experts deeply understand regulatory guidelines, such as current Good Manufacturing Practices (cGMP), which are essential in the BioPharma industry. They use this knowledge to design facilities that meet cGMP standards, ensuring that the CDMO’s operations fully comply with regulatory bodies like the FDA and EMA.

2. Project Management and Construction
Effective project management is critical to supporting CDMOs in the BioPharma industry. EPCMV firms provide project managers who oversee all aspects of facility construction, which involves coordinating various stakeholders, managing budgets, and mitigating potential risks or delays.

EPCMV experts are well-versed in the intricacies of BioPharma facility projects. They handle complexities like specification and procurement of process/lab equipment, aseptic processing, viral containment, potent compound handling, cleanroom design, HVAC systems, and utility infrastructure. Managing these aspects, EPCMV firms ensure that the facility is fully functional, efficient, and compliant with all necessary regulations.

EPCMV firms manage the entire project during the construction phase, from acquiring the necessary permits to supervising the installation and equipment installation and commissioning. They ensure the facility is built according to the approved design, within budget, and meets the typically aggressive schedule. CDMOs can leverage the EPCMV project teams to execute engineering and procurement activities successfully in parallel with core/shell construction activities. The connected design-build solution compresses project schedules and manages tight financial budgets concurrently, saving time and capital.

3. Validation and Compliance
Once the BioPharma facility is constructed, it must undergo a rigorous validation process to ensure that all systems and processes work as intended and comply with regulatory standards. EPCMV firms take charge of this critical phase. Validation includes equipment and facility qualification. EPCMV experts work closely with CDMOs to develop and execute validation protocols. EPCMV teams bring proven strategies to leverage quality life cycle design and fabrication deliverables to support the validation package. This meticulous approach is essential for guaranteeing the facility is ready to manufacture BioPharma products consistently and safely. CDMOs can leverage EPCMV firms’ validation experience to accelerate their speed-to-market/clinic.

EPCMV firms also help CDMOs maintain ongoing compliance with changing regulations. EPCMVs provide the necessary support to ensure the facility remains aligned with evolving cGMP requirements and industry best practices. EPCMV firms provide valuable preventative maintenance and asset management solutions to keep equipment and facilities up and running and aligned with evolving cGMP compliance expectations.

EPCMV firms provide CDMOs with the infrastructure and project management expertise required to build and maintain state-of-the-art BioPharma manufacturing facilities.

Conclusion

The partnership between CDMOs and EPCMV firms in the BioPharma industry is a symbiotic relationship that fosters innovation and accelerates the product development process. EPCMV firm experts help CDMOs design, construct, and validate their facilities, allowing them to focus on their core product development and manufacturing competencies. 

Through effective facility design, construction, project management, validation, and ongoing cGMP compliance support, EPCMV firms find creative solutions for CDMOs. CDMOs are empowered to operate efficiently and support their BioPharma clients’ aggressive schedules while meeting stringent regulatory cGMP requirements. Creating a solid business relationship between CDMOs and EPCMV firms is mutually beneficial and strengthened by a shared drive to provide innovative technologies and solutions to meet BioPharma’s ever-evolving needs for patients.

References
1. Market.us. (2024, January 30). CDMO Market Surges Towards USD 322.7 Billion by 2033 | Analyzing Growth in Pharmaceutical Manufacturing. GlobalNewsWire: https://www.globenewswire.com/news-release/2024/01/30/2819602/0/en/CDMO-Market-Surges-Towards-USD-322-7-Billion-by-2033-Analyzing-Growth-in-Pharmaceutical-Manufacturing.html

---

Timothy Kratzer is a Principal Engineer at CHA Consulting, Inc. (CHA). With over 30 years of expertise as a senior process/automation/reliability/project engineer, he has extensive knowledge of bio/pharma process/systems design, engineering, and operations. Tim’s experience includes overseeing several complex projects with successful execution from concept development to commercialization. For more information: tkratzer@chasolutions.com; www.chasolutions.com.