Going above and beyond

Nov. 4, 2024
This year’s Pharma Innovation Awards are creating tools that elevate precision and efficiency in every step of the drug manufacturing process.

From COVID-19 vaccines to curative cell and gene therapies to radiotherapeutics, every scientific leap is made possible by often-overlooked heroes — the manufacturing vendors who create the tools that bring precision and efficiency to every step of the drug development process.

Now, in its twelfth celebration, this year’s Pharma Innovation Awards winners are the quiet forces at work that help secure each achievement and lay a strong foundation that empowers drugmakers to keep pushing forward and reach new heights.

Process development and scale-up

Transitioning products from the lab to commercial manufacturing is one of the most defining steps in a drug’s journey. Its success hinges on addressing challenges such as scalability, consistency and adherence to regulatory standards.

Advancements made in this stage can directly impact patients, too. Companies that excel in process development can reduce time to market, improve product accessibility, and lower overall costs, making their therapies more affordable for patients.

Our first winner in this category, Watson-Marlow Fluid Technology Solutions’ WMArchitect range, is a versatile single-use fluid management system designed to support biopharmaceutical processes from lab research through full-scale production. Its open-architecture design allows seamless integration into existing systems, giving drugmakers the flexibility to upgrade without costly infrastructure changes.

The WMArchitect range also addresses one of the most significant challenges in scaling bioprocesses: reducing regulatory burden. By offering validation and regulatory support, this system helps companies meet regulatory requirements more efficiently.

Our second winner, Alphinity’s PIXER pump, is a single-use diaphragm pump designed to handle delicate biological materials such as high-value proteins and cells with minimal shear stress.

In bioprocessing biologically derived drugs, maintaining the integrity of their sensitive materials is a major challenge. High-pressure and high-viscosity processes can degrade their quality, potentially affecting the final product.

The PIXER pump solves this problem by preserving the integrity of these materials, ensuring consistent quality even as production scales up. Integrating sensors into the recirculation loops allows for PAT and closed-system integration of analytical instruments, supporting Quality by Design (QbD) manufacturing strategies to deliver life-saving therapeutics to patients faster. With flow rates ranging from a few mL/min to over 200 L/min, PIXER mixing pumps offer scalability from lab bench experiments to full-scale GMP manufacturing.

Lastly, the CQ3000 from Yokogawa Electric Company provides a key development in cellular analysis by combining advanced microscopy with automated data analysis in a high-content imager.

By facilitating high-throughput analysis, the CQ3000 enables researchers to gather detailed observations into cellular and molecular responses to various compounds, reducing the time and costs associated with early-stage drug development.

Cell and gene therapy

Cell and gene therapy (CGT) continues to be one of the most promising pharmaceutical treatment areas, with the global market expected to reach $97.33 billion by 2033.

And 2024 brought notable breakthroughs like Casgevy, the first gene therapy that uses CRISPR technology to treat sickle cell disease.

But even as the sector makes considerable progress, manufacturers still face persistent challenges related to high production costs, complex supply chains, and the scalability of these drugs. As more CGT therapies make it through FDA approval, innovation in manufacturing processes is crucial to keep pace with market needs.

Our first awardee in this category, Ori Biotech’s IRO, is designed with scalability in mind. IRO allows for a seamless transition from early process development and the ability to scale into GMP manufacturing with the same instrument, consumables and process.

One of the platform’s key features is its ability to automate and standardize key processes without sacrificing biological performance, offering closed and automated sterile fluid transfer, a novel bioreactor system, remote real-time data analytics, and flexibility in a single platform.

By streamlining tech transfer and reducing the cost of goods by up to 50%, the IRO platform not only accelerates the manufacturing process 

process but also helps to make CGT therapies more accessible. Additionally, with processing times reduced by up to 25%, the platform enables faster production, shortening the timeline for getting therapies from the lab to patients who need them most.

Also with the goal of shortening the timeline of CGT therapies, the M3DIMAKER 2 by FABRX is a revolutionary multi-printhead GMP pharmaceutical 3D printer designed to produce personalized medicines directly at the point of care.

Personalized medicine, especially in CGT, necessitates precise dosages tailored to individual patient needs. The traditional compounding process, which is labor-intensive and prone to variability, can introduce errors and inefficiencies, especially when manufacturing at scale.

The M3DIMAKER 2 addresses these challenges by automating the preparation of personalized dosages, minimizing the risks associated with manual compounding. By allowing for the production of custom formulations on-site, this printer simplifies the process of creating tailored treatments, reducing costs and improving patient safety.

Plant operations

From sterile environments to streamlined production processes, plant operations innovations can significantly impact the overall efficiency and safety of drug manufacturing.

This year’s innovations focus on strengthening plant operations by improving cleanliness, production speed, and cost-effectiveness, making it easier for drugmakers to strike a balance between meeting regulatory requirements and growing demand.

AES Clean Technology’s CleanLock Module is poised to be a game-changer in cleanroom management. This modular airlock system is designed to enhance cleanliness and reduce contamination risks in pharmaceutical manufacturing environments.

One of the key advantages of the CleanLock Module is its offsite-fabricated components, which allow for quick and cost-effective cleanroom expansions. The modular system also incorporates advanced HEPA filtration that captures 99.97% of airborne particles.

By making cleanroom expansion faster and more affordable, the CleanLock Module helps drugmakers adapt to changing production demands without compromising cleanliness or safety. Additionally, the CleanLock Module aligns with sustainability goals by reducing energy consumption, a growing priority for industry.

Sterility is another critical factor in plant operations, as the smallest amount of contamination can render a product unusable. In a seemingly tiny but mighty way, our second winner in this category, the Flush Fasteners’ F-Head Fastener, addresses this challenge by eliminating visible recesses in its design — common areas where bacteria can proliferate.

The simple yet effective design of the F-Head Fastener reduces the risk of bacterial growth, helping manufacturers avoid costly contamination issues that could compromise product quality.

Another understated yet impactful innovation, Colorcon’s Corelease OPL aims to streamline the formulation process for push-pull osmotic pump (PPOP) tablets.

Traditionally, producing PPOP tablets involves multiple steps, including complex solvent granulation processes that can be time-consuming and costly. The Corelease OPL system simplifies this process by combining multiple ingredients into a single, directly compressible powder, eliminating the need for solvent granulation altogether.

For manufacturers, this innovation translates into faster production times and lower costs. By reducing the number of steps involved in the formulation process, Corelease OPL allows manufacturers to increase efficiency and output without compromising the integrity of the final product.

In tablet manufacturing, KORSCH America’s X 5 Tablet Press is raising the bar for efficiency and versatility. Launched at this year’s INTERPHEX, this machine is designed for high-speed production, offering flexibility with its interchangeable turret, allowing manufacturers to produce single-layer, bi-layer, or tri-layer 

layer tablets on the same machine. This flexibility is particularly useful for manufacturers that need to switch between different tablet types without experiencing lengthy production downtime.

The X 5 Tablet Press also enables quick changeovers, which helps to minimize disruptions and increase overall production output. Its high-speed capabilities make it an essential tool for drugmakers that need to produce large volumes of tablets while maintaining strict quality controls. One of our reviewers called it, “Science and art combined.”

Packaging and inspection

With drugs becoming more complex, the demand for high-precision, automated packaging and inspection systems also grows. Manufacturers need solutions that can handle high volumes while ensuring that every product meets quality and safety requirements. 

This year’s innovation in this category looks to create more reliable, efficient solutions for drugmakers, helping to improve both packaging and inspection processes.

Antares Vision Group’s VRI Automatic Inspection Machine addresses this challenge by providing 100% automatic inspection of blow-fill-seal (BFS) containers at high speeds. BFS containers, often used for liquid pharmaceuticals, can pose unique challenges when it comes to inspection due to their complex shapes. The machine detects particles, cosmetic defects, and fill levels, ensuring that every container meets the necessary quality standards.

By automating the inspection process, the VRI Automatic Inspection Machine allows manufacturers to detect any imperfections or issues early, preventing defective products from reaching the market. Its high-speed capabilities and ability to handle large production volumes make it a competitive solution for companies looking to maintain strict quality controls while scaling up production.

Cold chain logistics

As the demand for biologics and other temperature-sensitive therapies increases, manufacturers seek advanced solutions to ensure reliable temperature control throughout the transfer of materials.

Innovations in cold chain logistics drive improvements in temperature control, monitoring, and overall efficiency, ensuring that these sensitive drugs are safely transported and stored.

As the only awardee in this category, Single Use Support’s RoSS.PADL is a homogenization system designed to handle single-use bags for biopharmaceutical liquids. By combining cooling, heating, and kneading, RoSS.PADL ensures the uniform distribution of cell counts in pharmaceutical liquids in preparation of aliquoting into smaller single-use bioprocess containers, which is crucial for maintaining consistent dosages. This is particularly important in biopharmaceutical workflows where deviations in active ingredients can affect patient safety.

The RoSS.PADL system enhances the reliability, consistency and accuracy of dosing, reducing the risk of ingredient separation during storage and transport. Its ability to preserve the uniformity of active ingredients throughout the cold chain ensures that patients receive the correct dosages, improving the safety and efficacy of temperature-sensitive therapies.

Data management

Like most industries, pharma is becoming more digitized, and data management systems are helping manufacturers maintain quality standards, avoid errors, and streamline production processes. This year’s winners in the data management category are providing tools that make data handling more reliable, secure and automated.

Our first awardee in this category, MasterControl’s Advanced Quality Event Management (AQEM) platform, is a user-friendly solution designed to streamline the management of quality events in pharmaceutical manufacturing. Quality events, such as deviations, non-conformances, and corrective actions, can be time-consuming and costly to manage manually. The AQEM platform automates these processes, allowing companies to create custom workflows that simplify the reporting and resolution of quality issues.

By integrating AI and automation, the AQEM platform helps manufacturers maintain high-quality standards while speeding up their operations. Its no-code interface makes it easy for manufacturers to create and modify workflows without the need for extensive IT support, making it a flexible and efficient tool for managing compliance in a highly regulated industry.

Emerson’s AMS Asset Monitor for Life Sciences offers a predictive maintenance solution through a continuous, online condition monitoring system that helps drugmakers avoid equipment failures. The system monitors variables such as vibration, temperature, and pressure in real time, providing insights into the health of manufacturing equipment. By identifying potential issues before they lead to equipment failures, the AMS Asset Monitor allows companies to schedule maintenance more effectively, reducing downtime and ensuring smooth production processes.

This approach to maintenance helps companies increase operational efficiency by minimizing unexpected equipment breakdowns and reducing repair costs. The AMS Asset Monitor also enhances safety by ensuring that equipment operates within specified parameters, reducing the risk of accidents or product defects. For manufacturers looking to optimize their operations and reduce costs, the AMS Asset Monitor helps ensure the reliability and safety of production equipment.

With the conclusion of our 2024 Pharma Innovation Awards, we sincerely thank all participating companies and dedicated suppliers driving progress in pharma manufacturing. As we move into 2025, we are eager to learn about more transformative breakthroughs and look forward to seeing how these innovations will continue to elevate our industry.

About the Author

Andrea Corona | Senior Editor

Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College. 

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