Taking a Look Inside the Modern Manufacturing Facility

The life sciences industry has traditionally been relatively conservative in making process changes, improving efficiency, adopting cutting-edge technologies and modernizing facilities. This cautious approach has served the industry well over the past few decades, ensuring business stability and patient safety. However, CRB’s most recent Horizons: Life Sciences 2024 report reveals a shift—many companies are now aggressively pursuing efficiencies and implementing innovative strategies to maintain market supply while upholding patient safety.

What is the Horizon’s Report?

This report, the fifth installment of our Horizons: Life Sciences series, invites North American, European, and multinational companies to share their perspectives on biopharmaceutical research and manufacturing. Built on the insights of 500 industry professionals, this facility-focused report offers guidance to stay ahead in the rapidly evolving life sciences sector. 

CRB’s subject matter experts examine how companies manage capital and operational spending in a challenging economic climate before exploring facility, equipment and process trends. This report is essential for forecasting the innovations that will shape the future of the industry.

Participants were evenly distributed between small, mid and large sized companies.

• 32% Small companies (1 - 499 employees)

• 36% Mid-sized companies (500 – 9,999 employees)

• 32% Large companies (10,000+ employees)

Where is the Industry Now and What Do We See on the Horizon?

Manufacturers are eager to embrace technology innovations in the production of biologics that not only enhance supply but do so with increased efficiency, improved safety and quality.  These are some of the areas we will dive into during the presentation at ISPE's Chesapeake Bay Area Chapter's 2025 Mid-Atlantic Science & Technology (MAST) Showcase.

What Changes are Occurring in Solution Preparation?

Solution preparation can account for a significant proportion of a facility’s capital expenditures in terms of floorspace and equipment costs, as well as operational expenditures in terms of labor.  We are seeing an industry-wide shift away from traditional buffer preparation and buffer hold toward inline dilution, inline conditioning and immediate use of buffers without hold vessels. We will discuss the challenges associated with these transitions along with the survey results.

What CGMP Production Processes Are Using Continuous Manufacturing Technology?

Most industries have completed the transition from batch processing to end-to-end continuous processing, demonstrating the benefits in efficiency, consistency and cost reduction. Regulatory organizations have modified their guidelines (e.g. definition of a batch) to allow for continuous CGMP bioprocessing. Although end-to-end continuous biomanufacturing may remain out of reach in the near term, a key takeaway from the survey is that most respondents are using or plan to adopt the continuous technologies we inquired about.

Making the Material Transfer Process More Consistent.

The effectiveness of manual wipe-down procedures for materials entering a cleanroom is 100% dependent on the individuals performing the task, making this process inherently inconsistent. As a result, automated methods are being implemented to resolve the risks of contaminants on the surfaces of manually wiped-down materials. Most respondents indicated that they use at least some form of automated decontamination methods, such as autoclaves, fumigation tunnels, UV, or e-beam technology.

How is Inline Sensor Technology Being Used to Support Real-Time Batch Analysis?

The data analytics available with inline sensor technology could eliminate process testing delays. It’s been 13 years since the Food and Drug Administration (FDA) and European Medicines Agency (EMA) released guidelines on real-time batch release for use in research and development. Technologies supporting real-time release testing continue to evolve, and the survey data suggests we’re starting to see this implemented in commercial operations.   

The Implementation of AI Looks Inevitable.

Although the industry is still determining how to best leverage AI, most respondents indicated they are at some stage of planning or executing AI integration for process data analysis in CGMP manufacturing. Since this is a rapidly developing field, most respondents indicated they have not started implementing their plan. It’s early in the game, but it’s encouraging to see the planning process has started.  

What Process Changes Are Being Used to Enhance Sustainability?

Respondents indicated that a range of approaches are currently being used or considered to improve the sustainability of CGMP manufacturing. Process changes must go through a change control process, requiring both internal and external process changes. It is exciting to see the industry recognizing sustainability as important enough to undergo these approvals and potential product similarity studies to implement these changes.

How Flexible Are Bioprocessing Facilities?

The flexibility to manufacture multiple modalities in a single facility seems important to most companies surveyed. BioPhorum refers to this as the ‘Ultimate Facility Design,’ a facility which is flexible enough to produce an ATMP and then switch to manufacturing a monoclonal antibody. While there are limitations to how flexible a facility can be —whether across multiple modalities or within the same modality—most respondents indicated they are operating multi-product facilities.

Embracing Innovation

As the life sciences industry embraces new technologies and modernized processes, the shift toward greater efficiency, safety, and sustainability is becoming undeniable. These innovations are not just improving current practices but are also paving the way for future advancements. By continuing to adapt and invest in cutting-edge solutions, manufacturers can meet the challenges of today’s dynamic environment and ensure a successful, sustainable future.