A craftsperson’s toolbox serves as a symbol of their skill, ingenuity, and dedication. It cradles a world of possibilities, unlocking tangible manifestations of imagination through the use of physical tools.
In a similar spirit, the pharma industry must continuously empower itself with cutting-edge technologies and equipment solutions in order to continue to produce lifesaving therapies. With drugmakers facing incredible pressures to get drugs to market quickly, safely and affordably, every addition to development and manufacturing efficiencies matters.
Now in their eleventh year, the Pharma Innovation Awards allow Pharma Manufacturing to acknowledge the investments that equipment and technology providers put into building and improving their products. Please join us in celebrating this year’s award winners, selected by our editors and reviewers, for hitting the nail on the head with their solutions to drugmakers’ most pressing issues.
Data management and visibility
From ensuring product safety and efficacy to navigating complex global regulatory requirements, effective data management practices are central to maintaining the highest standards in drug manufacturing.
Based on worldwide estimates, more than two-thirds of all pharma manufacturing is now outsourced through contract manufacturing and packaging partners. As a result, the efficient management and exchange of data with supply chain partners throughout the product life cycle is no longer a nice-to-have capability, but a strategic imperative that all manufacturers must possess.
With an eye on enhancing supply chain visibility and enabling end-to-end process orchestration, TraceLink’s Multienterprise Information Network Tower (MINT) is being recognized for its global supply chain impact. An end-to-end supply chain digitalization solution, MINT leverages TraceLink’s proprietary data exchange model for sharing real-time information among supply chain partners, resulting in improvements in revenue, agility and resiliency, while reducing business risk.
The solution enables users to exchange a large catalog of transactional business information, including purchase orders, advanced shipment notices, and invoices, with 100% interoperability among supply chain partners without forcing any changes to any partner’s enterprise business system.
In a landscape where many companies still grapple with the limitations of traditional communication methods like email-based file exchanges, MINT provides a flexible and streamlined solution that accommodates businesses at various stages of digital maturity.
Pharma’s clinical trial processes generate a substantial amount of data and the ability to derive actionable insights from that data is powerful. Our second awardee, DoseMe Analytics by DoseMe, is designed to help support drug developers through phase 3 clinical trials and aftermarket enrollment.
Within this environment marked by intricate complexities and uncertainties, this cutting-edge solution harnesses real-time data to redefine precision dosing. The software incorporates a personalized, adaptive dose adjustment approach rooted in a drug’s pharmacokinetics and pharmacodynamic properties to optimize efficacy and mitigate the risks of adverse drug events and toxicities. By seamlessly integrating into clinical trial infrastructures, DoseMe guides investigators away from traditional maximum tolerated dose trial designs and instead encourages a model-informed selection of patient-specific doses.
The dosing platform offers real-time support to investigators within their facilities, effectively reducing patient dropouts and potential study failure attributed to dose-related toxicities. Reviewers applauded DoseMe’s innovation for its efforts to lead clinical trials towards a more successful and patient-centric future.
Process development and scale-up
Transitioning drug products from lab to commercial scale is one of the most vexing tasks in pharma. During this process, regulatory compliance demands increase and quality control methods must be robust enough to detect variations and defects. Selecting equipment suitable for large-scale production adds another layer of complexity, involving considerations like material compatibility and ease of maintenance.
Our first awardee in this category, TriLink BioTechnologies’ CleanCap M6 is an advanced mRNA cap analog designed to maximize the impact of mRNA therapeutics and vaccines. Used in the first commercially adopted mRNA vaccine, the CleanCap capping technology reduces immune responses, increases mRNA expression up to three times, and streamlines manufacturing, with an estimated cost savings of up to 40% compared to other capping methods.
The latest CleanCap M6 cap incorporates two key modifications of the CleanCap technology, 3’OMe on the m7-guanosine and an additional methyl modification on the +1 adenosine. These modifications improve mRNA potency and yields with purity exceeding 95%. The technology’s single-pot reaction simplifies manufacturing, enabling quicker turnaround times and higher transcriptional yields. By driving down manufacturing costs and shrinking production times, the tool aims to help bring life-changing medicines to market faster.
Reviewers expressed optimism about the product, recognizing its promise as a valuable niche innovation that could enhance mRNA therapeutics — a relatively uncommon achievement in manufacturing processes. They commended the product as a great development and a useful tool, emphasizing its potential application in addressing global health care challenges.
Another major challenge faced in the development process for biologic drugs is protein aggregation. The next winner in this category, SentrySciences’ ParticleSentryAI software, plays a crucial role in helping drug developers detect changes in the aggregation caused by stressors not easily detected by a human. The software utilizes AI and subvisible particle imaging to establish a robust aggregate control strategy. Traditionally, managing aggregates relies on flow-imaging microscopy, but the immense volume of data and human limitations in interpreting these images present obstacles.
By using deep machine learning, ParticleSentryAI evaluates morphological and textural details within images, establishing fingerprints that swiftly and quantitatively pinpoint root causes of subvisible particle morphological changes. In doing so, it provides a robust foundation for continuous process verification, addressing scale-up challenges head on.
ParticleSentryAI overcomes limitations by leveraging image features to comprehend the causes of aggregation, delivering actionable data for mitigating their impact. By analyzing the images gathered, it can create a fingerprint for drugs under normal and stressed conditions, and detect significant changes in these fingerprints, supporting batch-to-batch consistency. Another favorite among reviewers, the product was applauded for its significance in addressing protein aggregation, with reviewers lauding its ability to automate a previously manual process. One reviewer called it an “innovation in dealing with a perennial issue.”
As the pharma industry trends towards more targeted drugs, small molecule active pharmaceutical ingredient (API) candidates are becoming more potent. At the same time, the industry is looking to streamline development and scalability, with an end goal of speeding market entry. Continuous manufacturing has emerged as a possible solution to these challenges.
To that end, Quotient Sciences’ FlowInova platform is being recognized for its ability to streamline the scale-up process for early-phase API development.By utilizing high-throughput experimentation and modeling, the platform significantly reduces the time and material quantities required for scale up within a laboratory setting, which translates to accelerated development timelines, cost savings, and greater productivity for drugmakers.
Born out of a collaboration with the University of Nottingham, the project also focuses on the informed decision-making aspect of development. It introduces automated reaction equipment and early-stage modeling, which leads to better decision-making for subsequent experiments. As data accumulates and process knowledge grows, predictive process models enable ‘virtual design of experiments,’ ultimately enhancing the overall efficiency and effectiveness of the development process.
A once overlooked area of pharma manufacturing, the modern day plant floor is proving to be a prime place to capture efficiencies and cost savings. One crucial element of plant operations that can often go unnoticed is water management.
In the pharma industry, the significance of water purity cannot be overstated, as it directly impacts the quality and safety of all products. Holding down the category this year, Xylem’s Sophis Digital Services — with an ambitious mission to redefine the way manufacturers manage critical water systems — is being recognized for its ability to mitigate risks through 24/7/365 remote monitoring and support while ensuring water quality and optimizing performance.
As a sophisticated water service solution, Sophis effectively prevents production-affecting problems by continuously monitoring vital water system data, including feedwater conductivity, membrane pressure, and permeate flow. Proprietary data models also identify anomalies that could disrupt production, triggering immediate alerts to the engineering team. Once an anomaly is flagged, a course of action is dispatched to the local service team, and upon completion, the event information is recorded for continuous learning. The result? Increased uptime and substantial capital savings for pharma manufacturers, along with the assurance of pharmaceutical-grade water purity.
Currently paired with the company’s VRx High Purity Water System, Sophis Digital Services delivers an all-encompassing solution designed to meet and exceed the stringent requirements for compendial purified water and Water for Injection (WFI) production, aligning seamlessly with USP, EP and JP monographs. With its approach to water system management, the solution not only addresses crucial industry challenges but also plays a vital role in ensuring the quality and safety of drugs for the benefit of patients worldwide.
Packaging and inspection
In an industry where regulations leave no room for error, the selection of both packaging materials and inspection methods plays a pivotal role in upholding the integrity of pharmaceutical products.
Our first awardee in this category, the Eagle-LP (Lab Pack) Blister Machine from Maruho Hatsujyo Innovations (MHI) alleviates two key pain points in pharmaceutical packaging: cost-effectiveness and space utilization. The unit is purpose-built to address persistent challenges in early-phase blister packaging, providing an economical alternative for stability testing, clinical trials and small-scale production, eliminating the need for expensive and space-consuming equipment.
The machine is specifically designed for small-scale processes, offering a unique, reliable and budget-friendly solution for various developmental phases. What distinguishes the Eagle-LP is its adaptability to newer, eco-friendly blister film materials, which are often more complex to shape and seal. The versatile unit seamlessly handles a variety of materials, including PVC, PVDC, PET, ACLAR, ALU and PP.
Reviewers expressed enthusiasm for the Lab Pack, describing it as a long-awaited remedy to a persistent issue.
In the charge for more sustainability in the industry, pharma packaging suppliers are at the forefront. In January 2018, the European Commission introduced the EU Plastics Strategy, which set the target of making all plastic packaging in the EU market recyclable by 2030, meaning that a certain portion of plastic packaging should be recyclable. The Packaging & Packaging Waste Directive currently mandates that a minimum of 65% of all packaging waste by weight must be recycled by the close of 2025. While pharma sector is exempt from the EU Packaging & Packaging Waste Directive mandates until 2035, it’s never too early to start preparing for this shift.
Taking a step in a greener direction, TekniPlex Healthcare takes the stage as our next honoree with its Transparent Recyclable Mid-barrier Blister Package. The company has introduced a groundbreaking solution — the world’s first fully transparent, recyclable mid-barrier blister package. The innovative offering not only provides robust moisture barrier protection but also champions recyclability where the #5 (polypropylene) recycling stream is available.
TekniPlex Healthcare’s mid-barrier blister pack pairs a polyolefin blister film with a barrier polypropylene lidding film, signaling a significant step towards achieving circularity in health care materials. It’s a milestone that deserves recognition as the first certified recyclable combination of a formed blister and lidding in the health care packaging sphere that’s fully transparent. The transparency allows for vision systems to see through the package to detect a variety of potential quality control issues, including a damaged tablet or capsule, presence of any foreign substances, or closure integrity (making sure the blister is properly formed and sealed). The company’s initial assessments of manufacturability have yielded highly encouraging results, underscoring the potential of this tool to revolutionize drug packaging.
In the packaging realm, visual inspection is another crucial quality control step that comes with its own unique set of challenges. Ensuring that drug products are free from defects and meet stringent quality standards is of utmost importance. But variations in container types, substances, and the need to detect particles, cosmetic imperfections and closure integrity issues pose significant hurdles. The demand for high-speed performance, adaptability and precision further complicates the process.
Innovative solutions, like Stevanato Group’s MAVIS Combi, have emerged to tackle these issues head-on, offering advanced performance, flexibility and speed to enhance visual inspection.
The inspection machine, part of Stevanato’s MAVIS line, has the capabilities to handle a diverse array of glass-filled drug containers, including syringes, vials, ampoules and cartridges, making it a versatile asset for manufacturers navigating varied product formats. MAVIS Combi also showcases precision in identifying particles, cosmetic imperfections, and closure integrity issues, addressing paramount concerns for product quality and safety, and can process both bulk and ready-to-use containers.
In addition to its versatility, the MAVIS Combi offers a compact design that optimizes visual inspection efficiency. Its high-speed performance is a standout feature, processing up to 400 pieces per minute, outpacing industry standards. This efficiency boosts production throughput while maintaining quality control, providing a much-needed solution to meet rising demands in pharma packaging inspection.
Cold chain logistics
The pandemic proved definitively that as supply chain operations expand to larger geographic areas or larger volumes of sensitive goods, the complexities of managing temperature-controlled facilities and transportation increase substantially. Crucially, deep-cold medications, such as mRNA-based therapies and cell and gene therapies, demand specialized handling, containment and delivery systems.
SCHOTT Pharma’s SCHOTT TOPPAC freeze prefillable polymer syringes are being recognized this year as effective packaging for these frozen or thawed medications, even those that require storage and transport at extremely low temperatures, nearing -100°C.
The syringes, made from cyclic olefin copolymer, are break-resistant, biologically safe and equipped with advanced cross-linked siliconization technology to ensure drug stability. They also come with comprehensive data to verify container closure integrity, functionality and particulate generation after freezing and thawing.
SCHOTT TOPPAC freeze syringes support the safe and stable delivery of these extremely cold medications throughout the supply chain, provided to drugmakers in a standardized nest and tub configuration. This compatibility ensures easy integration into major fill-and-finish lines, helping pharma companies to efficiently and safely bring deep cold medications to the market using prefillable polymer syringes for the first time.
Our next winner in this category, the RoSS.pFTU XL from Single Use Support is an innovative plate-based freezing and thawing unit that addresses critical issues in biopharma cold chain logistics. It can freeze up to 10 single-use bags, each with a 50-liter capacity, setting a new standard for bulk freezing.
The technology rapidly freezes batches down to -90°C in under 10 hours while allowing for precise control of the freezing rate to suit specific product needs. The unit stands out as the only plate-based freezer for large volumes, offering fast and precise freezing. It helps minimize product quality loss due to cryoconcentration, preserving drugs’ attributes during freezing or drying. This technology guarantees product integrity and efficacy throughout the freezing process while enhancing overall process efficiency.
The RoSS.pFTU XL also ensures reproducibility, meets regulatory standards (21 CFR Part 11) and eliminates manual handling concerns. Its modular design supports scalability and accommodates various single-use bioprocess containers, making it a key component in the quest for a fully scalable end-to-end process for bulk fluid and cold chain management.
Cell and gene therapy
It’s no secret that cell and gene therapies (CGT) represent a revolutionary approach to managing disease, with the potential to disrupt how patients are treated and eventually even cured. However, the promise of CGT hinges on drugmakers’ ability to bring these lifesaving drugs to patients safely, effectively and affordably.
Chief among the challenges faced in the sector is scalability. Starting in small research laboratories, CGT processes must scale up to meet growing clinical and commercial demands. This necessitates innovative manufacturing methods that balance product integrity with quantity, calling for advanced bioreactors, automation and a deep understanding of biology.
Leveraging the capabilities of large language models, cell and gene therapy developers can now, for the very first time, proactively analyze and mitigate crucial manufacturing risk factors before embarking on the journey of scaling up production. To this end, our next winner, Form Bio’s FORMsightAI has emerged as a pioneering tool, ushering in a new era of predictive efficiency and safety in the development of these groundbreaking therapies.
The comprehensive solution integrates advanced, customizable AI/ML models crafted to confront prevalent challenges encountered by developers. Specifically, it addresses issues like construct truncations and manufacturing contaminations, both of which significantly contribute to unsustainable low manufacturing yields, extended time-to-market, and potential therapeutic safety concerns.
FORMsightAI has the potential to streamline manufacturing to save time, money and resources, which could ultimately accelerate the delivery of critical therapeutics to patients who need them.
Designed to address the labor-intensive, time-consuming, and inconsistency-prone nature of manual cell isolation and bead removal processes, our next award goes to the Gibco CTS DynaCellect Magnetic Separation System from Thermo Fisher Scientific. This system responds to a crucial need in the market for a closed, automated platform that effectively overcomes challenges while ensuring exceptional isolation efficiency, recovery rates and cell viability.
A favorite among our reviewers, one reviewer called it “timely and innovative,” expressing that the system has the potential to become a standard in cell isolation. In comparison to alternative methods that often demand 4–5 hours for cell isolation, the CTS DynaCellect system reduces the processing time to approximately 100 minutes. Additionally, it significantly shortens Dynabead removal time from roughly five hours to less than one hour, accelerating the development and delivery of transformative therapies that have the potential to change lives.
The device’s capacity to swiftly process 1,000-mL for cell isolation and offer continuous processing for bead removal positions it as a critical asset for successful scale up. Moreover, its modular design allows seamless integration into a variety of workflows, enhancing instrument efficiency and utility, making it a potentially transformative tool within the realm of pharma manufacturing.
With that, we conclude our 2023 Pharma Innovation Awards. We want to extend our appreciation and gratitude to all the participating companies and the hardworking suppliers that remain dedicated to advancing the industry. As we look to 2024, we anticipate even more groundbreaking developments, and we’re excited to see how these innovations continue to shape the pharma industry.