The tradition of putting candles on top of a birthday cake has been around for a long time.
Ancient Greeks would do it to pay tribute to their gods. In the mid-19th century, Germans began igniting candles to symbolize the ‘light of life,’ and it didn’t take long for the tradition to spread across Europe and over to America. While it’s no longer explicitly religious, we still hold superstitious beliefs around those little wax sticks shoved into our frosting. Each year’s cake brings with it an opportunity to ponder the past, take another turn around the sun and make a wish.
Here at Pharma Manufacturing, it’s been a big year for birthdays. Our magazine turned 20 years old last month, and now we’re blowing out ten candles on our Pharma Innovation Awards.
For a decade now, the Pharma Innovation Awards have highlighted industry-focused technologies and systems that not only help to solve pharma’s current woes but also push the boundaries on what is possible within pharma manufacturing.
Although perhaps cliché, we believe that taking this opportunity to applaud pharma manufacturing innovation leaders is important — allowing for the celebration of the light that has been created through problem-solving and invention, and reflection about what we might wish to see in the future of our industry.
Without further ado, let's get this party started and celebrate this year’s Pharma Innovation Award winners: 16 standout technologies selected by Pharma Manufacturing editors and reviewers.
Biopharma
The pharma industry is in the business of healing people, and biologics have proven good for business — grabbing both the headlines and the cash.
The global biopharmaceutical market reached $328 billion in 2021 — and is predicted to skyrocket to $853 billion by 2030. Last year, four out of the top five best-selling drugs in the U.S. were biologics.
The single-use technology field is rapidly expanding in the biopharma space, and manufacturers need products designed specifically for this environment.
Earlier this year, Equilibar unveiled its SDO Single Use Back Pressure Regulator with the intention of disrupting this market by creating the first true wetted valve, offering control beyond a simple tube-pinching action. The SDO is a 1:1 dome-loaded multi-orifice single-use valve that controls upstream pressure. The product is most commonly used as a trans-membrane pressure control valve (TMP) and can be used in both upstream or downstream processes, such as filtration or chromatography.
Traditional positive displacement pumps have been found by engineers to generate high-frequency pulsations, so the valve’s rapid response helps protect cells or any other biologics from these harmful pulsations. Additionally, since the valve is pneumatically operated, it's extremely easy to automate.
Pharma Manufacturing’s reviewers were particularly excited about the valve’s potential to give operators more precise control. The SDO's unique design with pneumatic pilot affords customers an ultra-wide flow range, millibar-precise valve that has native millisecond response to disturbances without any control loop feedback — improving TMP control.
For manufacturers looking for a smarter, faster and easier way to make sterile connections for biopharma, cell therapy and gene therapy manufacturing, our next winner delivers. Providing proof that good things come in small packages, Colder Products Company’s (CPC) MicroCNX Sterile Connector is the most compact of its kind available on the market, with a design that helps solve big — but literally small — problems.
The MicroCNX sterile connector is designed to provide a simple, efficient method of connecting tubing in small-format assemblies. This tiny connector — offered in 1/16", 1/8" and 3/32” sizes — brings a much-needed alternative solution to traditional tube welding of small-volume closed aseptic processes. The MicroCNX works in a three-step ‘pinch-click-pull’ installation — users pinch to remove the connector's protective cover, click its two halves together, and then pull out the protective membranes to allow flow to move through the connector.
The product is being recognized for its intuitive, straight-forward connection process that will potentially minimize operator errors, as well as ease performance and reliability concerns.
Given current clinical trial trends, experts estimate that by 2025 there could be as many as 10-20 new cell and gene therapies approved each year. As manufacturers begin to ramp up their cell and gene therapy manufacturing processes, they will need products that propel the nascent sector forward.
Stepping up to help, Single Use Support offers the RoSS.FILL CGT, a fully automated, aseptic cell and gene therapy and biologics filling system that allows for multiple single-use bags below 1000 mL to be filled at the same time.
First installed for the scale-up of lentiviral production at CDMO Genezen, the platform can be used for dispensing a range of biologics into single-use bags, such as viral vectors, cell cultures and cell and gene therapies. It can accurately fill up to 36 single-use bags with one rack. The system has stepper and sealer valves that provide variable fluid control for quick filling and aseptic decoupling in an automated one-process step, saving time and resources.
Overall, the RoSS.FILL CGT is being recognized for providing a straightforward solution to an industry need, with one reviewer calling it, “responsive to a growth market.”
Process development
For years, the rallying cry for better biologics has been ‘the process is the product.’ Our next three winners offer much-needed innovation towards the end goal of accelerating and improving process development.
Carrying out biopharmaceutical production — which relies on manipulating complex cell reaction systems with a large number of set parameters — is extremely challenging. As each cell in a bioreactor generates the material that forms the active ingredients, constant monitoring of their individual metabolic reactions, as well as real-time visualization and analysis of any environmental factors such as changes in pH and dissolved oxygen is needed.
Our first winner leverages artificial intelligence and mechanistic knowledge to enable cell culture performance prediction. Yokogawa Insilico Biotechnology released its Insilico Digital Twin Factory, which can help drugmakers increase productivity and bring down manufacturing costs and time to market by potentially replacing up to 50% of the experiments needed during the process development, characterization and scale-up of biopharmaceuticals.
The digital twins use an advanced hybrid blueprint formed from a mechanistic model of the unique characteristics of an intracellular metabolic network and a data-driven model to allow for the constant prediction of elements such as the soft sensing of substance components that cannot be measured directly, or the early detection of process abnormalities. Last year, Yokogawa released its “Insilico Advisor,” to help improve the efficiency of biologics manufacturing by providing for model predictive monitoring of the cell culture process.
Another significant development challenge facing the industry is poor solubility, especially when it comes to antibody-drug conjugates (ADCs). This emerging class of medicines — designed to target and destroy cancer cells while preserving healthy cells — can fail in the clinic due to poor aqueous solubility.
Our next winner, ChetoSensar technology from MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, offers a viable solution to solubility woes. The chito-oligosaccharide is designed to improve solubility, reduce aggregation, improve therapeutic index and conjugation efficiency, and achieve a higher drug-to-antibody ratio in ADCs.
The technology works with a broad range of linkers/payloads, provides flexibility with the linkage site and conjugation technologies, and also works with non-traditional antibodies which would not be considered otherwise. ChetoSensar is being highlighted for its ability to give hope to ADCs that were previously terminated, helping to bring these novel treatments to cancer patients around the world.
Our next winner is being recognized for its ability to speed scale-up in upstream environments; Advanced Instruments’ OsmoTECH HT Automated Micro-Osmometer offers a solution to cumbersome manual osmolality testing processes, which can require multiple interactions and limit the efficiency of testing.
The automation-friendly 96-well plate format with a low sample requirement of just 50 uL is specifically designed to meet the high-throughput needs of cell line development, clone screening, early process development and formulation development. It has the consumable capacity to perform up to 1000 tests allowing for uninterrupted testing.
The OsmoTECH HT is automated to provide a hands-free walkaway testing experience allowing scientists to optimize their high throughput osmolality testing while ensuring accurate performance and data integrity. The ability to integrate osmolality testing into automated workflows helps accelerate formulation development and stability testing by providing excipient concentrations and confirming the soluble content of formulations. Advanced Instruments’ automated solution is positioned well to support the growing automation and high throughput needs in busy bioprocessing labs.
Aseptic processing
The need to minimize contamination risk from personnel, materials and equipment remains a priority in pharma manufacturing – so innovation in aseptic processing is always welcome.
To enclose items and keep sterility after autoclave processing, manufacturers turn to sterilization wrapping products. But it's not uncommon for flexible sterilization wrapping to have an antistatic coating on the surfaces which, under steam conditions, can leave a residue on the product contact surface.
Inspired by the challenge, STERIS Life Sciences collaborated with Tyvek manufacturer DuPont, to develop a cleaner grade of flexible Tyvek without any surface coatings specifically designed for pharma steam sterilization applications. The result? Purefit Sterilization Bags and Covers — the first on the market made from an uncoated grade of flexible (fabric-like) Tyvek material.
These bags and covers maintain the sterility of the wrapped items post-sterilization through the transportation and storage processes until the equipment is installed for use on the filling line. The flexibility of the material makes it suitable for many wrapping needs, including critical filling line equipment that is very large and bulky (such as stopper bowls) or very small (such as filling needles).
Manufacturers are also looking to remove risks of cross contamination in their process by reducing operations inside the aseptic area — and many are turning to automation as the solution.
Telstar’s Smart Format is a new automatic vial format change system for freeze-drying loading and unloading processes that removes the need for manual interventions during the change of formats. Multiple formats that were previously manually changed can now be replaced by the Smart Format system, designed to automatically adapt to the vial diameter, without the need to interrupt the containment or isolation process. Sterility level is assured without repeating cleaning or decontamination processes of the transport system for each different format.
The flexible solution is designed to manage any layout configuration to transport vials from filling lines to freeze dryers and to capping machines, with the goal of preserving product integrity and operator safety. The system uses a mobile platform that is configured to fit a wide range of vials from a 2 ml injection vial to a 100 ml injection vial.
Plant operations
For pharma manufacturers, the plant floor is where the bulk of the action happens, offering endless opportunities for process improvements. Plant operations innovations can help drugmakers to streamline processes — while also increasing efficiency and driving down costs.
This year's plant operations innovators stepped up to meet the industry’s changing cold storage needs, reimagine a plant floor staple, and offer alternatives to traditional validation life cycle management systems.
The WL820 temperature-controlled cold room, from refrigeration powerhouse Polar Leasing, is the only validated leased cold storage solution available to accommodate the stringent temperature control requirements for the pharma industry.
The ground-resting, 8'x20' temperature-controlled cold rooms are a walk-in dual temperature freezer/refrigeration unit specifically designed and engineered for pharma customers, providing a consistent and reliable temperature range of 46º F to -22º F.
Because the units are a one-piece fiberglass design, they are resilient and immune to weather changes. The units arrive preassembled and prewired, and ready to operate. The rooms can be placed anywhere as long as they have an even surface, helping companies to support their cold storage needs in a modular, flexible way. As an added bonus, these electric-powered cold storage rooms support companies' economic and environmental objectives by eliminating fumes, fuel bills and diesel engine noise.
Our next winner innovates a plant floor staple — the tablet press — one of the pharma industry’s oldest and most trusted technologies. Disruption in this space is still a welcome upgrade for most manufacturers. With the aim of redefining tablet presses for small-scale and mid-range production, KORSCH has introduced the X 3 Tablet Press.
The X 3, which one reviewer described as having “big machine features in a small package" was designed from the ground up to include a new approach to architectural and ergonomic design elements — previously available only on larger machines.
The single-sided rotary tablet press is ‘smart’ and Pharma 4.0 ready, permitting a deeper understanding of what is happening in the compression suite. This increased visibility helps optimize both the process and the way the process is executed by the operations team — ultimately maximizing product quality.
As manufacturing processes become more complex, proper documentation and traceability have become vital. Managing validation projects on paper-based processes can create issues like fragmented data, lack of visibility and data silos — yet many quality teams rely on paper because not many alternatives exist.
Veeva Systems' Vault Validation Management application to help companies manage the validation life cycle, creating traceability and visibility across an organization's system inventory, requirements and deliverables. The system eliminates the reliance on manual processes, enabling teams to execute digitally, and drives standardization for paperless validation execution. This allows users to instead focus on value-added activities. Since Vault Validation Management is unified and connected with other Veeva Vault Quality Suite applications, staff undergo a consistent user experience across all quality processes. For companies that are already Veeva customers, this will lead to an integrated experience where validation co-exists with other quality processes, and related data, content and workflows can be seamlessly shared across systems and teams.
Quality
Reducing the risk of contamination, as well as reducing quality assurance and compliance burdens, is an ongoing quest for pharma manufacturers. Few industries have higher quality control stakes than pharma. When at the other end of a product there is a patient whose life might depend on it, there is no margin for error. And while achieving higher quality is sometimes associated with cumbersome procedures, this year's winners prove otherwise.
Our first winner is Emerson’s DeltaV Spectral Process Analytic Technology (PAT), a closed-loop process control system that enables fully automated production, reducing manufacturing variability by seamlessly embedding the PAT process into its controls.
The DeltaV Spectral PAT is being recognized for its ability to collapse the traditional layered PAT approach, deploying embedded PAT in real time, and simplifying the maintenance of closed-loop process control. According to Emerson, their design dramatically reduces the quality validation process and removes the risk of human error entirely.
Additionally, the system’s integrated environment makes it easier for users to implement and maintain, as they can monitor multivariate data from the interface used to perform all other control steps.
The solution was a favorite among Pharma Manufacturing’s reviewers, with one reviewer commenting that it will “significantly impact continuous manufacturing PAT processing."
Automating quality control can help manufacturers decrease both waste and cost. Our next winner has created a system that helps shorten testing times for pressurized metered-dose inhaler (pMDI) canisters from days or weeks to seconds, while also supplying high sensitivity to even low gas leak rates.
Optimal Industrial Automation’s iPass for MDI Aerosol Microleak Detection System is a robotized system that automates the leak detection of pMDIs at speeds necessary for manufacturing. The machine works by placing pMDI canisters on an upstream external conveyor, then moving them onto an infeed constant speed carousel conveyor that features space for individual products and can retain any gas leakage at the individual level. The belt then moves the products through a gas-analyzing system tunnel that purges the air around the canisters, leaving each puck individually sealed.
It’s important that MDI canisters — typically used in asthma inhalers — are produced with an optimum level of gas propellant, but leak testing has traditionally proved challenging. These fully automated machines address the shortcomings of traditional leak testing, either replacing or supplementing traditional loss-in-weight testing. According to one reviewee, the iPass is “a clear step forward in QA and avoids a chronic problem with these packages.”
This is Optimal’s second time being recognized as a Pharma Innovation Award winner. Last year, the company was awarded for its synTQ 5.5, a vendor-agnostic, PAT knowledge management and quality-centric software suite.
Keeping efficient quality control in mind, WIPOTEC’s All-in-One Inspection Unit kills two birds with one stone: precision check weighing and X-ray detection of foreign objects.
Nicknamed the ‘weigh and ray,’ the unit features the company’s proprietary Electro-Magnetic Force Restoration weigh cells, a differentiating engineering design that guarantees precise weighing results. Following this, the unit incorporates a seamless X-ray scanner to detect foreign objects made of metal and other materials, and even has filters available to track for other abnormalities.
The machine’s vision system can detect aesthetic-driven quality control issues, such as incorrect film, missing labels or incorrect label placement. Visual inspection processes that were once performed by workers and relied on the human eye can now be flagged in seconds. The machine not only rejects products but can even categorize them so operators can be made aware of the problem immediately.
Packaging/labeling
The final step in the plant floor process, packaging and labeling are crucial to assuring products make it safely to patients. Innovative packaging and labeling systems also have the propensity to help manufacturers capture efficiency savings, without compromising on quality or compliance.
As the demand for more advanced therapies and vaccines goes up, the temperatures needed to store these products are going down.
With that in mind, Schreiner MediPharm has introduced the Freeze-Lock Cryo Label — a label that meets modern needs. The product permanently withstands the sub-zero storage and transport temperatures needed for many cell and gene therapy medications and clinical trials —including those for COVID-19 mRNA vaccines.
The design incorporates two interlocking layers that ensure adhesive strength and information clarity. Due to the specialty, proprietary two-component label design as well as the materials and adhesives used, the Freeze-Lock reliably adheres to frozen containers, ensuring important product information is not lost.
The Freeze-Lock Cryo Label was accoladed by several Innovation Award reviewers, with one reviewer calling it an “excellent use of adhesive technology and a much-needed product.” Notably, this is Schreiner MediPharm’s second consecutive trip to the Innovation Awards winner’s circle — the company received big accolades from reviewers last year for its Smart Blister Packs & Vial Boxes.
Beyond the physical considerations of a drug product, drugmakers must also protect products from other threats, such as counterfeiting. Alitheon's FeaturePrint enables authentication, identification and traceability of individual items out of millions of similar objects; creating a one-of-a-kind, unique identifier that does not require marking.
Advanced machine vision technology provides immediate and irrefutable identification that can significantly reduce or virtually eliminate the risk of theft and fraud while providing an easy experience for users. Users can take a picture of the product — using a phone, an existing camera on the production line, or anything else — and the app's optical AI algorithms create a version of what fingerprints are to humans, but for each product. This information is readily available for traceability, identification and authentication review by drugmakers, distributors or even regulators.
Ultimately, the technology’s approach prevents counterfeit-related issues not by trying to detect counterfeits but instead by irrefutably identifying originals — a helpful step forward in today’s complex pharma supply chain.
That’s a wrap for the 2022 Pharma Innovation Award winners. Thank you to all of the companies that submitted entries to this year’s awards. And thank you to all the vendors that work tirelessly to ensure pharma’s bright future.
