2023
Best in Show
IMA Life North America Inc
INJECTA
Editor’s Choice
Schunk
ADHESO Energy-Free Gripping Technology
Biotech Innovation
PAK BioSolutions Inc.
Pilot PAK
Best New Product/Service
DEC Group
BoMa Dosing System
INTERPHEX Efficiency Champion
Thomas Processing
ACCELA CTC 500
Best Technologies Innovation
West Pharmaceutical Services
READY PACK
2022
Best in Show : Sievers Instruments by SUEZ
Sievers M500 Online TOC Analyzers and Software
Editor’s Choice : IsoAir Pro-Plus
Particle Measuring Systems
Biotech Innovation : Delta Cube™ Pharma Drug Packaging Solutions to Select Vial, Stopper & Seal
West Pharmaceutical Services
Best New Product/Service : Featured in our M Lab™ Collaboration Centers, the Bio4C® Software Suite enables integrated, digitally-enhanced, and connected unit operations.
MilliporeSigma
INTERPHEX Efficiency Champion : Apprentice.io
Tempo Manufacturing Cloud
Best Technologies Innovation : The LYnfinity LAB
IMA SpA-IMA Life division
2021
Best in Show: SKAN
Cellana Series Isolator Systems for Cell and Gene Therapy Product Manufacturing
Best New Product/Service: Millipore Sigma
Procellics™ Raman Analyzer with Bio4C™ PAT Raman Software
Editor’s Choice: Apprentice.io
Intelligent MES Platform
Best Technologies Innovation: West Pharmaceutical Services
NovaGuard SA Pro Safety System
INTERPHEX Efficiency Champion: Quartic.ai
First in market Bayesian AI based DoE and Bayesian batch Optimizer
Biotech Innovation Award: Catalent
GPEx® Lightning – Next Generation Cell Line Engineering to Speed the Path to Clinic
2020
Best in Show: MilliporeSigma - The BioContinuum™ Buffer Delivery Platform
The BioContinuum™ Buffer Delivery Platform integrates buffer concentrates, buffer dilution system, Mobius® Select assemblies and services providing the ideal path to intensify buffer preparation and management with simplicity and certainty. The Platform delivers a competitive edge by supplying process buffers from point of manufacturing to point of use utilizing a fraction of the resources and facility space while increasing speed and flexibility. The combination of buffer concentrates, Mobius® Select single-use, highly accurate and precise buffer dilution system and tailored services enables biomanufacturers to eliminate buffer preparation and management bottlenecks while reducing cleanroom floor space and capital expenditures, while adding preparation flexibility. In totality, the simplicity and certainty of the Platform enables the evolution of bioprocessing.
Best New Product/Service: Malvern Panalytical - Amplify Analytics
This collaboration binds together Concept Life Sciences’ expertise in discovery chemistry, API screening and GMP manufacturing with Malvern Panalytical’s extensive capabilities for detailed solid and morphological form analysis. The Amplify Analytics service improves outcomes by directly linking API selection to both ADMET and microstructural assessments, ensuring developable candidates are rapidly and accurately identified. In addition, the Amplify Analytics team can directly deploy the physicochemical characterization techniques and methods required to ensure process and quality control, thus supporting scale-up and manufacturing programs. This is a unique partnership which integrates API selection, manufacturing and characterization, accelerating product development to deliver improved development outcomes and a much faster return on investment.
Editor’s Choice (sponsored by Pharmaceutical Outsourcing): MilliporeSigma-The BioReliance® Blazar™ Platform
The BioReliance® Blazar™ Platform meets the need to accelerate detection of adventitious viral contamination. This rapid molecular platform/degenerate PCR approach detects panel specific targeted viruses and related, but unknown viral contaminants and benefits the industry in several ways. It accelerates the broad and sensitive detection of adventitious viruses by replacing biological growth-based systems with a molecular approach. It provides manufacturers with accurate and highly sensitive viral detection in just days. Combining the breadth of detection of NGS with the speed and sensitivity of PCR. The Blazar™ Platform relies on degenerate PCR primers enabling coverage of beyond 5000 viral variants and will drive transformation of biosafety testing, particularly since the current method was developed in 1964. The Blazar™ platform enables biopharma to bring therapies to market faster.
Best Technologies Innovation: Fluid Air - PolarDry Electrostatic Systems
PolarDry Electrostatic Systems were designed around a complete line of patent-pending machines enabling easy scale-up from R&D through production size models. The systems utilize electrostatic technology which drives water to the shell and active to the core, lowering the evaporation temperature and eliminating active ingredient loss, degradation, or denaturalization. Harnessing the electrostatic effect, the dispersed active driven into the core is microencapsulated, virtually eliminating surface active, resulting in stunning encapsulation efficiency. PolarDry Electrostatic Systems offer a revolutionary way to process powder ingredients, at lower temperatures, to produce a better-quality drug, with a longer shelf life.
Efficiency Champion: SUEZ - Sievers TOC Analyzers and Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform
The new Sievers Eclipse BET Platform, along with Sievers TOC Analyzers, increase efficiency of quality control testing of water and other applications within the pharmaceutical, biopharmaceutical, and medical device markets. The new BET platform automates endotoxin assay setup through precise microfluidic liquid handling and embedded endotoxin standards. It maintains full compliance with the harmonized pharmacopoeias with embedded standards derived from the reference standard endotoxin produced by the USP along with FDA licensed limulus amoebocyte lysate. The Eclipse enhances the product development lifecycle by simplifying an otherwise antiquated and cumbersome benchtop assay and decreasing demand on natural resources. Using the Eclipse, manufacturers can gain operational efficiency by reducing pipetting steps by up to 89%, reducing analyst time by up to 85% and reducing the use of horseshoe crab lysate by up to 90%. The Eclipse enables fully compliant, 21-sample assay setup in as little as 9 minutes. Together, the new Sievers Eclipse BET platform and time-tested Sievers TOC Analyzers, part of SUEZ – Water Technologies & Solutions, increase productivity and ensure compliance.
Biotech Innovation: Meissner Filtration Products - AccuFlux® Integrity Test Instrument
The AccuFlux® tests and delivers industry standard filter integrity test results (i.e. bubble point, diffusive flow, pressure hold, water intrusion) for critical applications in a fraction of the time that currently available integrity test instruments require, thus saving valuable operator and manufacturing time. The AccuFlux® can test filter integrity pre- and post-use to guarantee sterility for qualified release of final product to market. With the AccuFlux®, for example, a bubble point or diffusive flow test can be performed in 3 minutes or less. That reduces the time required by an operator to perform this test by 70%, which streamlines efficiencies and reduces total cost of labor.
2019
Best in Show: SKAN US – SKANFOG® Spectra Modular Aseptic Processing and Sterility Testing Isolator System with SKANFOG, NANOX and Total Service Response, Booth #3140
The SKANFOG® Spectra Modular Aseptic Processing and Sterility Testing Isolator System is used in all phases of small-scale pharmaceutical and biotech production, but is primarily used in manufacturing steps for drug product fill-finish, cell and gene therapy, open aseptic process containment and sterility testing in the Quality Control Microbiology Lab. On the performance side, items can be transferred into an isolator 2-3 times faster than ever before while the overall isolator decontamination cycles are 4-8 times faster than previous models. In the total service model, full project management and cycle qualification is provided with guaranteed performance. With over $1 Million in US-stocked spare parts and a specialized team of factory trained and certified available 24/7 for emergency response, the SKAN Service offering sets a new standard for concept through life-cycle support of a critical manufacturing system.
Best New Product/Service: MilliporeSigma – Single-use Pellicon® Capsules with Ultracel® Membrane, Booth #2841
Single-use TFF with Pellicon® Capsules with Ultracel® Membrane eliminates the cleaning steps before and after product processing for increased facility throughput. This considerably shortens the total process time compared to that of a TFF process with a multi-use device. The holderless, self-contained design of the Pellicon® Capsule with Ultracel® Membrane is ideal to easily and safely remove the entire single-use TFF flow path immediately after product recovery. This enhances product changeover efficiency and saves time, labor, fluids and footprint in the manufacturing plant due to no cleaning validation requirements, ultimately increasing plant productivity and process flexibility with reduced contamination risks, offering additional user-friendly features to reduce process complexity, save time, and conserve resources in the filtration of mAbs and other biologics.
Editor's Choice (sponsored by Pharmaceutical Processing): Grand River Aseptic Manufacturing Inc. – Flexible Commercial Manufacturing Expansion, Booth #1466
The fee for service business model utilized by contract development and manufacturing organizations, such as GRAM, benefits the industry by creating efficiencies in the marketplace that would otherwise not exist. With this in mind, the new, state-of-the-art facility further enables the flexibility for small clinical batches and large scale commercial pharmaceutical manufacturing. GRAM has worked with vendors such as SKAN, IMA, Bausch+Ströbel and Marchesini to outfit its new facility with state-of-the-art equipment and technologies. These investments significantly increase manufacturing capacity and overall flexibility to the client. New equipment includes: IMA's LyoMax Lyophilizer which more than triples lyophilization capacity; the fully integrated, high-speed, Bausch+Ströbel filling line, also tripling vial filling output per minute and the high-speed Marchesini packaging line is capable of packaging and serializing 200 cartons per minute with aggregation.
Best Technologies Innovation: Meissner Filtration Products – CryoVault™ Platform, Booth #2341
CryoVault™ platform, a new freeze/thaw platform for biopharmaceuticals addresses the industry's need for large scale solution and meets the needs of industry with a robust, scalable, truly single-use solution for 100 L+. End-to-end solution for freezing, storing, distributing and dispensing critical high value biopharmaceutical fluids, e.g. BDS. It addresses a challenging and critical process step that allows the end-user the flexibility to customize the solution for their specific process based on the selection of pre-qualified components which have all been engineered to work together seamlessly. No longer do manufacturers need to choose between conventional cryovessels with the associated cleaning/maintenance challenges, and a single-use solution which may not meet their needs in terms of performance. CryoVault™ provides the best of both worlds and allows end-users to harness
the benefits of single-use systems without sacrificing performance.
INTERPHEX Efficiency Champion: Southfork Instruments – Kemtrak SU UV Absorbance Cell System, Booth #1338
The Kemtrak Single-use UV Absorbance Cell System is used as part of a UV absorbance measurement circuit and can be used with a DCP007-UV process scale UV absorbance analyzer, even at discovery level, so data developed directly transfers through the scale up process. This direct transfer allows faster development, removes cross contamination between batches, lowers cost in use and I scale-up and ensures faster peak detection and endpoint, offering greater yield and purity. This System takes an existing measurement type and innovates an improved solution that solves issues that really exist. The Kemtrak system uses modern components with user friendly engineering to provide a better measurement with lower cost that can actually provide shorter development cycles for products in the industry and is applicable at all stages of product development from lab scale through production scale.
Biotech Innovation: Optima Pharma/Metall+Plastic – DECOpulse® Biodecontamination System, Booth #3103
DECOpulse® Biodecontamination System with atomization-driven evaporation of hydrogen peroxide is utilized in upstream processes of aseptic production of pharmaceuticals as well as in quality control in aseptic production. Reduction of microorganisms is achieved with vapor phase hydrogen peroxide, whereby the innovative approach of the evaporation by atomization of the liquid hydrogen peroxide solution is applied. With this approach a better and faster distribution of the H2O2 can be achieved. This addresses the general challenge of homogenous exposure of surfaces with adequate amounts of hydrogen peroxide in decontamination processes. Consequently, this leads to a faster decontamination and more productive time by shortened decontamination cycle times. With the innovative concept of using atomization-driven evaporation by creating droplets of a defined size, it clearly differentiates from the existing systems. The concept allows shortened decontamination cycle times, more productive time and higher product safety because of reduced outgassing.
2018
Best in Show: Varnx Pharmasystems – Microcell Vial Filler, Booth #3805
A completely robotic aseptic filling machine built within gloveless isolators, creating a highly repeatable filling process for complex drug products. The Microcell is designed for drug development, early clinical trial supply production, and manufacturing of autologous cell therapies, gene therapies, immuno-oncology products, and other personalized medicines. Depending on the batch size, the Microcell can produce at least 4 autologous therapies in an 8-hour shift and as many as 8 with a batch size of 100 units or less.
Best New Product/Service: Nymi – Nymi Authentication Solution, Booth #1373
The Nymi Authentication Solution features a brand new multi-factor authenticator called the Nymi Band™, a biometrically authenticated wearable that simplifies log attempts across the manufacturing process, from raw material R&D through to finalizing batches to be shipped out to end users. Due to the Nymi Band being faster at logging actions into the system, there is an efficiency gain across the board. Higher security and adherence to regulatory and more savings through an increase in efficiency.
Editor’s Choice (sponsored by Pharmaceutical Processing): LifeAire Systems – The LifeAire System, Booth #1575
This patented, multi-staged, in-duct air purification system designed for the needs of cleanroom, living cell culture, and clinical environments, are ideal for the manufacture of pharmaceutical and biotech intermediates and end products requiring highly-controlled production and testing where sensitivity to ambient air is a factor. It involves a comprehensive removal of chemical and biological airborne pathogens and toxic levels of VOCs and viable particulates present in the processing space not addressed with current GMP and ISO metrics.
Best Technologies Innovation: MilliporeSigma – Millistak+® HC Pro, Booth #2841
This Portfolio is a “next generation” technology that delivers higher productivity, increased speed, and reduced risk. Biopharma manufacturers have the choice to eliminate naturally-derived components from their bioprocess clarification train and can now use a depth filter with reduced total organic carbon (TOC) extractables that enables a 50 percent reduction in pre-use flush volumes and eliminates a possible source of beta glucans, which can interfere with Limulus Amebocyte Lysate (LAL) endotoxin assays. Lot-to-lot consistency helps biopharmaceutical manufacturers design a more robust clarification process.
INTERPHEX Efficiency Champion: Steris Life Sciences – Steris VHP DC-A, Booth #3121
Steris VHP DC-A is a new generation of vaporized hydrogen peroxide decontamination chambers for transfer of materials, components, and material bags into aseptic manufacturing cleanroom areas. The new product decontaminates surfaces of transfer material loads under room temperature and atmospheric conditions and minimizes particulate burden effectively that would otherwise transfer to the cleanroom side along with the unloading.
Biotech Innovation: groninger USA – FlexPro50, Booth #3611
This manual or fully loaded automated modular filling and closing system offers maximum process safety in aseptic fill/finish reducing the risk at human intervention. Ready-to-Use vials, cartridges, and syringes can be processed on one line configuration by changing format parts; additional flexibility is given by exchanging the machine trolleys to process vials in trays or in bulk in the same line configuration. Hand gloves on front and back of the main and add-on isolators allow machine access from both sides. A new Direct-Injection-System reduces the decontamination cycle by 50 percent. The line can be changed to process different products in two hours.
2017 Winners
Best in Show: Asahi Kasei Bioprocess - IBD™ 1K Inline Buffer Dilution System
The time-saving IBD™ 1K System is a compact, standard offering of the existing Inline Buffer Dilution technology; the new system controls pH and conductivity simultaneously with unrivaled accuracy. It combines PAT with a patent-pending dynamic inline mixer so that conductivity and pH set points can be achieved more rapidly, with greater precision, and at higher dilution factors. The System produces diluted, pH-adjusted buffers at dilution factors of up to 20X so you can maximize resource allocation in your purification suite.
Best New Product/Service: Bio-Rad Laboratories – ZE5 Cell Analyzer
The ZE5 Cell Analyzer is an innovative new flow cytometer with flexible configurations to meet a broad range of experimental complexities and throughput needs, providing the industry with its first truly expandable flow cytometer. This flexibility makes the ZE5 Analyzer accessible for novice users yet flexible enough for the most experienced professionals. A fully integrated sample loader with the ability to handle tubes or plates without an instrument hardware change enables true walk-away functionality.
Editor’s Choice (sponsored by Pharmaceutical Processing): Nemera – Safelia® Autoinjector
Safelia® is an innovative Autoinjector, declined in 1ml and 2.25m platforms for prefilled syringes, able to administer high volumes, high viscosities and through thinner needles. It has been designed to ease patient self-injection experience and to deliver, in glass syringes, fluid formulations to challenging drugs (viscous, sustain released, concentrated, in subcutaneous or intramuscular layers, in large volumes).
Best Technologies Innovation: Watson-Marlow Fluid Technology Group – The Quantum Pump
Quantum offers a step change in pump technology for bioprocessing enabling higher downstream process yields throughout the pressure range exceeding the performance of any other pump available. The new bioprocessing pump with patented single-use technology provides exceptional downstream process performance, delivering higher yields and improved flow linearity throughout the 44 Psi pressure range. This product out performs any other bioprocessing pump available, with ultra-low shear and a class leading 4000:1 turn down ratio.
INTERPHEX Efficiency Champion: Bausch & Ströebel Machine Company – KPC Machine
The KCP offers a flexible filling platform with four configurable modular processing stations and can simulate a variety of different industry standard dosing, closure placement, sealing, and inspection arrangements currently used in commercial production of parenteral products. With two clean room robots, the filling and closing machine provides a wide range of applications for small batch production or process and product development. Virtually any customary container can be processed on the line with minimal changeover time. Completely different work steps can be integrated in the work flow.
Biotech Innovation: Millipore-Sigma - Pellicon® 3 Ultrafiltration Cassettes with Biomax® Membranes and D Screen Geometry
Pellicon® 3 ultrafiltration cassettes with Biomax® membrane and D Screen geometry are used downstream to efficiently process high-viscosity therapeutic protein formulations resulting in higher final product concentrations needed for injectable therapies. Prior to ultrafiltration, the drug is very pure but needs to be concentrated and formulated to the final condition. For the patient and physician, injectables offer greater convenience, increased compliance and lower costs. The manufacturer achieves more efficient processing with the Pellicon® 3 cassettes and has the ability to store and transport drug substance at higher concentrations which saves time and money.
2016 Winners
Best in Show:GE Healthcare Life Sciences
GE Healthcare Life Sciences was recognized for KUBio™, a prefabricated cGMP-compliant facility and process solution designed for the scalable and cost-efficient production of monoclonal antibodies (mAbs). Prevalidated modular units and processing equipment are transported to a specified site. They are assembled on site, and the resulting facility is qualified and ready-to-run within 14 to 18 months. To learn more about this technology, visit booth 3141.
Best New Product/Service: Nemera
Nemera was recognized for Novelia® BFS, a preservative-free multi-dose eyedropper combined with bottlepack® technology. Novelia® works with high viscosity suspensions and solutions of up to 1500 cps and limits the distribution of liquids to one drop at a time. The doses of the drops are precise, which intended to assist medication adherence. To learn more about this technology, visit booth 1636.
Editor’s Choice: Catalent Pharma Solutions
Catalent Pharma Solutions was recognized for OptiForm® Solution Suite, a detailed molecule assessment with high throughput screening and parallel assessment of formulation technologies. It is designed to help solve complex bioavailability challenges for early stage molecules using a unique toolkit of bioavailability enhancing technologies. OptiForm® Solution Suite matches the best formulation technologies to a molecule and utilizes an accelerated parallel screening and development approach. To learn more about this technology, visit booth 1546.
Best Technological Innovation: Videojet Technologies
Videojet Technologies was recognized for Videojet® 7510 50-Watt Fiber Laser Marker, a laser marking system with high contrast marking on robust plastic packaging, metal containers, as well as other industrial products. Operating on speeds on to 440m/min., this technology delivers better mark quality and has a smaller marking unit, compared to traditional solid state laser systems. To learn more about this technology, visit booth 2725.
Efficiency Champion [NEW]: Millipore Sigma
Millipore Sigma was recognized for Mobius® 1000 L Single-Use Bioreactor, a stirred tank bioreactor that configures software, hardware, and single-use assemblies for use in suspension and adherent cell culture applications. It functions as a standalone system or integrated as part of a facility’s automation platform. To learn more about this technology, visit booth 2841.
Biotech Innovation Award [NEW]: Bausch + Stroebel
Bausch + Stroebel was recognized for VarioSys®, a flexible processing line based on the lock-and-key principle. This pharmaceutical production system features a flexible pharmaceutical/biotechnological processing line, modular design, and standardization of subassemblies. In a special isolator enabling production in clean room class A conditions, individual production modules can be installed that fit on the lock-and-key principle—for instance, a machine for processing syringes in nests or a filling and closing machine for vials. To learn more about this technology, visit booth 2505B.
2015 Winners
Best in Show — Pall Life Sciences
Pall Life Sciences was recognized for their new Cadence™ single-pass tangential flow filtration (SPTFF) technology that uses a staged flow path design to achieve significantly higher concentration factors (2-4x or greater) in one pump pass than is possible with conventional TFF systems that include a recirculation loop. The key innovation offered by the Cadence single-pass tangential flow filtration (SPTFF) technology is the ability to achieve the significant concentration of downstream biopharmaceutical process streams in a single pass without the need for recirculation. With this technology, smaller volumes, higher titers and higher product recoveries are achieved compared with those possible with conventional TFF systems.
Honorable Mention, Best in Show — GE Healthcare Life Sciences AxiChrom
GE Healthcare Life Sciences was recognized for the AxiChrom column platform, a revolutionary concept in column chromatography that has been extended to feature new 1.2 and 1.6m columns to overcome many of the challenges related to increasing column size. AxiChrom columns help reduce operation time with its automated packing methods. But the intelligence of AxiChrom goes beyond automation: its purposeful design enables excellent chromatographic performance through its axial compression capabilities and distribution system properties. The innovation of the new AxiChrom columns are scaled-up manufacturing and many time-saving features.
Best New Product/Service — Apprentice Field Suite
Apprentice Field Suite is awarded Best New Product/Service for the Apprentice Field Suite, trio of applications exclusively for Smart Glasses that empowers biopharmaceutical manufacturing operators and engineers to help them make informed decisions. The three applications, TANDEM, MANUALS and GAUGE, leverage Augmented Reality, Computer Vision, Telepresence, and the Myo Armband to provide essential data, process and workflow aids, and sophisticated troubleshooting interfaces. TANDEM, was developed as a way for remote engineers to view exactly what operators are seeing in the manufacturing suite. This greatly improves communication and speeds up the troubleshooting process. MANUALS, is able to interface with companies existing standard operating procedures, batch records, job plans and more. The biggest innovations come from GAUGE. This computer vision software automatically reads and saves analog gauge values, and can warn operators about which bioreactor is still in use prior to cleaning the vessel.
Editor’s Choice Award (sponsored by Pharmaceutical Processing) — Fette Compacting
Fette Compacting is recognized for its entire FE series of tablet presses, displayed together for the first time at the same show. Headlined by the North American debut of the FE75 double-sided press, other models include the FE55 and FE35. The core design philosophy threading its way through the FE series is that of Fette’s Tri.Easy concept. Tri.Easy represents the simplification of the three primary aspects of tablet press use-those of changeover, operation and maintenance. The FE75 is an ultra-high-speed, double-sided tablet press with superlative capabilities featuring three manufacturing modes: mono-layer manufacturing, with double-sided discharge; direct compression for difficult products; and double-layer manufacturing, with single-sided discharge. The FE series fulfills the unique requirement of providing presses that can produce an ever greater number of tablets, while occupying less space on the manufacturing floor while simultaneously providing users with the technological versatility for compressing an overwhelming majority of potential tablets on one press.
Best Technologies Innovation — G-CON Manufacturing, GEA and Pfizer
G-Con Manufacturing is recognized for the Portable, Continuous, Miniature and Modular (PCMM) platform. PCMM is a standardized production technology platform used for product development and commercial manufacturing offering a process analytical technology (PAT)-compatible process control solution for continuous wet granulation and continuous mixing/direct compression, enabling efficient transfer from development to clinical and commercial production without scale-up that is easy to deploy and ship. A key advantage is being able to use the same equipment throughout the entire product lifecycle. In addition, the PCMM platform combines equipment design, PAT, advanced process control and engineering expertise to deliver a fully integrated cGMP facility using PODs. This first-of-a-kind system has the potential to transform the future of pharmaceutical process development and manufacturing while providing the flexibility needed to address the evolving portfolio requirements for in-country and small-lot manufacturing.