In the pharma and biopharma industry, drug manufacturing must evolve to meet ever-increasing demands for safety, versatility, efficiency, and quality. As a CDMO for fill and finish for injectable products, there are several challenges that Vetter expects to be the driving forces behind manufacturing needs to meet the dynamic evolution of the global healthcare market.
Nils Bischoff, Product and Service Manager, Vetter Pharma International GmbH further discusses today’s manufacturing challenges, equipment advances and areas of production innovation.
 
Contract Pharma: What are some manufacturing challenges clients look to overcome? 
 
Nils Bischoff: Continuous change of product portfolio: Pharmaceutical service providers face an increasingly conflicting challenge to their processes. Both large-scale blockbuster drugs and small batch products such as orphan drugs are experiencing an increasing demand for manufacturing capabilities and require very different production processes and considerations, along with intricate handling requirements for more complex biologics. 
 
Need for greater flexibility: To meet the varying needs of different molecule groups together with product-specific requirements for formats, packaging, temperature, and more, flexible manufacturing processes are of critical importance. New approaches to technologies with sufficient versatility are in high demand.
 
High Quality: Process reliability and product and operator safety are critical to navigating regulatory requirements. Customers and global authorities are increasing their regulatory requirements for process safety including additional requirements for microbial and particulate contamination control. New and revised guidelines continue to be published. One example is the new EU GMP Annex 1 which became effective in August 2023. 

Security of supply: Procurement departments need to tackle challenges on multiple fronts — constantly monitoring the availability of products, signing service agreements in advance, building strong relationships with suppliers, consistently investing in safety stock, and employing smart risk management.
 
The goal of any CDMO is to proactively establish practices and serve as a reliable partner to customers who deliver medications to patients in need them around the globe. Leveraging innovative approaches such as the Vetter Cleanroom Technology (V-CRT), which combines the benefits of isolators and Restricted Access Barrier Systems (RABS) and goes beyond the conventional solutions, helps clients overcome manufacturing challenges.
 
Contract Pharma: What are some of the latest advances in manufacturing equipment?
 
Nils Bischoff: Equipment for drug production must advance rapidly to keep pace with the evolution of the pharmaceutical and biotech industry. Recently, we have seen an increase in built-in versatility and a high degree of automation in manufacturing technology. There is a strong shift throughout drug product production from a former human-centric approach to a fully automatic production process, utilizing robotic technology where possible to reduce direct human intervention and ultimately eliminate manual intervention altogether. 
 
Holistic cleanroom concepts like V-CRT are designed to optimize pharmaceutical production processes and include advances such as optimized decontamination cycles and a port and airlock system for material transfer. Rapid decontamination enables efficient product changeovers and reduces downtime. Ultimately, this improves overall equipment effectiveness (OEE). For further optimization, Vetter uses a two-step setup in which steam-sterilized equipment only enters Class A when decontamination is complete, protecting the liquid path from H2O2. 
 
We are also seeing an increased number using port systems and the corresponding operator processes within the cleanroom environment. Beta-containers with direct connections to the ports allows the beta-container to remain in grade B while the sterilized goods are unloaded in grade A. To maintain a focus on preventing H2O2 contamination, an airlock between grades C and B areas allows contamination-free transfer of non-autoclavable materials into the cleanroom. 
 
Finally, the need for small batches is growing as research into rare diseases increases. In general, the challenge of producing high-value drugs in small batches is to maximize API yield, flexibility, and time to market. Fully automated and flexible gloveless isolators that meet Annex 1 requirements are setting a new industry standard to meet customer demands.
 
Contract Pharma: In what areas do you see production innovation and/ or new technologies being used? 
 
Nils Bischoff: In industries that evolve as quickly as pharma and biotech, innovation and technological advancement are expected in almost every area. As digital transformation impacts nearly 1 billion jobs in the next decade, according to the World Economic Forum, this is only further proven. The rapid evolution of the pharmaceutical industry, combined with the digital revolution and the rise of robotics and AI-based software makes it nearly impossible to identify a single area that is experiencing the most innovation.
 
One such area is that of camera and sensor monitoring systems, which are increasingly being used to continuously record, display, store, and analyze data. One example is the monitoring of cleanroom environments. Integrated monitoring not only tracks the aseptic filling process itself, but also protects the integrity of the drug products and the employees.
 
At Vetter, sensors inside and outside the barrier are used to track different variables such as Polytron sensors that measure H2O2 decay in the Class B cleanroom, while a Picarro sensor tracks the same process in the Class A cleanroom. In addition, flow meters continuously measure airflow from the barrier area into the surrounding cleanroom air. Another example of innovative camera technology in pharmaceutical manufacturing is the increasing use of high-sensitivity cameras and associated AI software in automated visual inspection machines for quality control.

Further reading: Manufacturing Equipment Trends