Ascending to new heights

While pharmaceutical manufacturing remains complex and highly regulated, innovators are leveraging industry-leading best practices and technologies to overcome barriers with new approaches and processes to navigate the challenges in how drugs are developed and manufactured. Cutting-edge technologies are improving production efficiency, product quality/safety, time to market, as well as supply chain management.

Pharma Manufacturing’s 2025 Pharma Innovation Awards shine a spotlight on those innovative companies that are pushing the boundaries of science and technology to advance the field. This year’s awards recognize the progress being made in setting new standards of excellence and ascending to new heights of achievement in pharmaceutical manufacturing, as they shape the future direction of the industry.

The awards include innovators redefining bioreactor technology, cell and gene therapy manufacturing, pharmaceutical packaging, and small molecule active pharmaceutical ingredients.

Bioreactor advances

Digital and cloud-based technologies are revolutionizing a wide range of industries, including biopharmaceuticals. Cloud-based biomanufacturing is a transformative approach that integrates bioreactors with remote data monitoring, automation, and artificial intelligence (AI)-driven optimization.

One company that is leading in that space is Culture Biosciences with its Stratyx 250 — what it contends is the first cloud-integrated, mobile bioreactor for cell culture process development. Designed to provide biotech companies with automation and remote process control, the new bioreactor system accelerates bioprocess development and reduces costs for applications from cell line development to protein expression.

According to Culture Biosciences, the Stratyx 250 provides a16% lower total cost per run compared to traditional benchtop bioreactors, while enabling 25% faster development timelines, and 30% improved scale-up success. The system remotely tracks and adjusts bioreactor parameters in real-time, eliminating the need for constant on-site supervision.

At the heart of the system is real-time process monitoring through its fully integrated Culture Console software, automatically collecting and analyzing data, reducing errors, and improving reproducibility to optimize cell culture conditions and enhance yield. In addition, the Stratyx 250’s Culture Console software leverages AI and machine learning workflows to generate data-driven precision for bioprocessing. The single-use bioreactor also eliminates cleaning and reduces downtime.

Although stainless steel remains the commercial backbone at very large scale, single-use technology is the workhorse for pharmaceutical development and early clinical. Single-use technology is driving progress and flexibility for pharmaceutical manufacturing, providing a valuable alternative to conventional instrumentation. As single-use technology develops, it is becoming increasingly user-friendly and efficient. Not surprisingly, single-use bioreactor systems have emerged as popular production platforms.

To meet growing demand for clinical trials and regulatory approved products, Cytiva has expanded its Xcellerex X-platform to include 500L and 2,000L bioreactors. The single-use portfolio is designed to increase operational efficiencies and production capacity, while helping to lower costs, reduce risks, and manufacture therapeutics more quickly.

Designed to meet the process needs of early-stage clinical researchers all the way through to commercial manufacturing, Cytiva’s Xcellerex X-platform portfolio and its added features offer the ability to scale operations efficiently and reliably in a single solution.

To minimize the risk of batch failure and error, the Xcellerex X-platform has a quick and easy “off-the shelf” bag configuration and installation as well as a rigid base construction for consistent installation of the single-use bioreactor bag. In addition, an infrared-based camera enables detection of foam appearing in the process, providing the ability for automated and early intervention.

Thermo Fisher Scientific is another company innovating in the rapidly evolving field of bioprocessing, with the introduction of what the company describes as the first-of-its-kind, bench-scale 5L DynaDrive single-use bioreactor.

Compared to traditional glass bioreactors, the benchtop-sized 5L DynaDrive bioreactor provides a 27% increase in workflow efficiency to accelerate the development process, reduce time-to-market, and boost the overall productivity of lab operations, according to Thermo Fisher.

Designed to meet the needs of large biopharma, contract development and manufacturing organizations (CDMOs), and small biotech companies, Thermo Fisher’s 5L DynaDrive provides scalability from 1 liter to 5,000 liters, as researchers transition from small-scale experiments to large-scale production.

While traditional glass bioreactors are a significant environmental burden with their consumption of large amounts of water, the 5L DynaDrive has the potential to save up to 18,000 liters of water annually — a major benefit when it comes to sustainability.   

Cell and gene therapy manufacturing

While the cell and gene therapy sector continues to achieve major regulatory milestones and the clinical pipeline is robust, challenges remain for manufacturing these potentially life-saving modalities. The therapies are complex and difficult to manufacture, with scale up frequently cited as an obstacle to regulatory approval and commercialization.

However, two companies — Cellares and Ori Biotech — are each providing innovative manufacturing technology solutions that leverage automation as the industry looks to produce cell and gene therapies at scale. This year, both companies respectively announced that they have received the Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration (FDA).

The AMT designation was created for novel technologies that substantially improve the manufacturing process, including reducing development times and supporting the production of certain drugs affected by supply disruptions. The FDA initiative encourages manufacturers to adopt advanced tools that improve reliability, product quality, and scalability for critical therapies.

Cellares’ automated cell therapy manufacturing Cell Shuttle platform was granted the AMT designation by the FDA’s Center for Biologics Evaluation and Research, giving its customers priority review from the agency leading to accelerated regulatory filings and resulting in decreased times to Investigational New Drug (IND) and Biologic License Application (BLA).

The Cell Shuttle performs automated, end-to-end, cell therapy manufacturing, including the processes of cell enrichment, cell selection, transduction, transfection, activation, expansion, and formulation while meeting all in-process and final product specifications of commercial cell therapies, according to the company. 

Cellares claims it can deliver to customers 10 times the scale of manufacturing at half the price of current manual processes. The Cell Shuttle is engineered to simultaneously handle 16 cartridges — which means therapies for 16 patients — and automates the entire process.

Ori Biotech’s IRO platform has also received the FDA’s AMT designation, which the company contends validates the system as one of the first next-generation technologies recognized under the program. With the designation, developers using IRO are supposed to gain earlier and more frequent engagement with the FDA throughout the regulatory process.

The IRO system automates, digitizes, and standardizes labor-intensive steps of cell and gene therapy manufacturing in a fully closed system. According to Ori Biotech, the platform reduces costs, increases throughput, lowers batch failure rates, and enables scalability from research through GMP manufacturing.

By automating and digitizing critical processes, IRO is designed to streamline manufacturing workflows and overcome bottlenecks that limit patient access. At the same time, the platform supports both research and development and GMP manufacturing on the same system, offering a seamless transition between the two.

IRO’s R&D flexibility allows for the optimization of processes, while maintaining precision and control that is critical for GMP manufacturing. The platform reduces demands on labor by up to 70%, lowers the cost of goods by up to 50%, cuts processing times by up to 25%, and shortens tech transfer timelines from months to just weeks, according to Ori Biotech.

About the size of a large microwave oven turned on its end, IRO automates the core parts of the cell and gene therapy manufacturing process — about 70% of current workflow — while increasing throughput by between 10 times and 50 times that achieved with existing manual manufacturing processes.

Dual-active material science technology

As a new class of pharmaceutical packaging, dual-active material science technology can simultaneously control both moisture and oxygen inside a medicine container or medical device packaging. The dual-active technology has the potential to transform how drugs and medical devices are protected, stored, and delivered, providing improved efficacy, patient safety, and shelf life — positioning it as the new standard.

Aptar CSP Technologies has developed a dual-active material science technology engineered to simultaneously control moisture and oxygen, which the company contends is ideal for sensitive formulations including oral solid dose drugs, medical devices, implantable mesh devices, microarray patches, and transdermal delivery systems.

Drugmakers have typically used separate solutions to combat the problem: moisture-absorbing packets for humidity, and oxygen scavengers for air. However, Aptar CSP’s technology combines both functions into one integrated material, simplifying packaging and improving drug protection.

Regulatory compliance with global standards for stability and safety is a critical aspect of Aptar CSP’s dual-active material science technology, which is designed to help companies meet International Council for Harmonization (ICH) requirements for how stable a drug must be under various conditions.

According to Aptar CSP, there has never been a singular, standalone active material aimed at protecting against both oxidation and moisture-related degradation at this level of precision across multiple platforms. The company notes that its technology can be customized for a range of product formats and development stages, from early R&D to commercial launch, including oral solid dose glucagon-like peptide-1 (GLP-1) medications — which are particularly vulnerable to both moisture and oxygen.

The solution is based on Aptar CSP’s 3-Phase Activ-Polymer technology, incorporating active chemistries to provide moisture control, gas scavenging (including oxygen, carbon dioxide, ethylene, formaldehyde, nitrosamines), microbial pathogen reduction, as well as aroma reduction or emission. The dual-active material is formed into films, blisters, or inserts, which are then incorporated into the final packaging. However, this can also occur during the manufacturing process to ensure the package is protected from the beginning.

Process development, manufacturing of APIs

Over the past two decades, the complexity of small molecule active pharmaceutical ingredients (APIs) has surged. Consequently, many development pipelines now require 20 or more synthetic steps with researchers testing many routes and reaction conditions to reach the final product — a time-consuming and resource-intensive approach.

However, working with the Fraunhofer Institute for Industrial Mathematics, Lonza has developed the Design2Optimize platform which enhances process development and manufacturing of small molecule APIs by using optimized experimental design to extract maximum insight from fewer experiments, producing faster decision-making, lower costs, and a streamlined process.

Lonza’s Design2Optimize platform combines physicochemical and statistical models with a continuous optimization loop, a hybrid proprietary approach to chemical process development — even for complex or poorly understood reactions — that significantly reduces experimentation time and resource use accelerating the path to manufacturing.

A major innovation of Design2Optimize is that it creates a digital twin for each process to facilitate in silico scenario testing and predictive modelling, while reducing the reliance on physical trials and speeding up development timelines, according to Lonza. The platform is based on an optimized design of experiments (DoE), enabling drug developers to build predictive models much more quickly. The physicochemical models provde a better understanding of possible synthetic methods than empirical models generated with statistical DoE.