Best in Show: SKAN, Cellana Series Isolator Systems for Cell and Gene Therapy Product Manufacturing
The Cellana product line is specially designed for Cell and Gene Therapy applications in the biopharma industry. There are two main models that distinguish themselves with unique design features that improve product quality with better process control and sterility assurance. The modular Cellana-M series utilizes pre-designed module and equipment interfaces to allow the rapid deployment of many different solutions, including an optional detachable incubator interface and many rapid transfer options that allow for the secure transfer of living cells and other fragile material without damage from sterilants or cryopreservatives. The Cellana-L series provides ultimate flexibility and scalability with the use of the award winning “L-flange” design. The L-flange has now been adapted to interface with complex lab equipment and processes, as well as robotic aseptic vial filling equipment. Now a product can be made from initial cells to final product within a single isolator system.
About the Award: The Best in Show Award recognizes accomplishments and display in the use of knowledge, innovation, and state-of-the-art technologies to achieve extraordinary levels of quality, production goals, and objectives—ultimately transforming critical and affordable life-enhancing ideas to finished drug products.
Best New Product/Service: MilliporeSigma, Procellics™ Raman Analyzer with Bio4C™ PAT Raman Software
Procellics™ Raman Analyzer with Bio4C™ PAT Raman Software is an easy-to-use GMP Process Analytical Technology (PAT) platform to monitor cell cultures in-line and in real time, from process development to manufacturing, to prepare the facility of future and allow bioprocessing 4.0.
This software helps improve processes, save time, provide flexibility to operators, reduce the risk of contamination and batch failures, and can help implement a nutrient control loop strategy, a first step towards automation.
Built specifically for biopharma manufacturing by bioprocessing experts, Bio4C™ ProcessPad Software is a data collection, visualization, and analytics software platform that facilitates 21 CFR Part 11 compliance and enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).
Intelligently combining process data from disparate data sources such as batch records, paper-based, manual records, QC results, databases (e.g., QMS, MES, LIMS), and machine data into a single, contextual, integrated data source, Bio4C™ ProcessPad ensures process information is current, complete, and accessible throughout the product lifecycle. Out-of-the-box data visualization and analysis tools mean users don’t need to be data scientists to understand, explore, and analyze their data.
About the Award: The Best New Product/Service Award is given to the exhibitor that encourages, develops, and features the very best in new products or services showcasing knowledge, innovation, and state-of-the-art technologies leading to significant business, economic, or manufacturing benefits for the pharma and bio industries.
Editor’s Choice: Apprentice.io, Intelligent MES Platform
Apprentice.io’s disruptive technology helps life sciences companies get life-saving drugs to market faster by connecting global workforces and scaling complex manufacturing. The company offers an intelligent cloud platform that integrates wearable and mobile devices, augmented reality, and voice recognition into a virtual collaboration application and a robust manufacturing execution system to reduce production costs, increase adaptability, and scale processes. Learn how 15 of the top 20 US Pharma companies use Apprentice to accelerate high-quality production of drugs for all diseases, from COVID to cancer, at www. Apprentice.io
About the Award: The Editor of Pharmaceutical Processing awards the Editor’s Choice Award, which is based upon her view of the best in exhibiting in Knowledge, Innovation, and Technologies within the pharma and biopharma industries.
Best Technologies Innovation: West Pharmaceutical Services, NovaGuard SA Pro Safety System
The NovaGuard® SA Pro safety system has expanded to include a 0.5mL device for standard 0.5mL glass syringes, in addition to the 1mL device that is available for 1mL long glass syringes. This is important for injectable drug therapies including low molecular weight heparin where branded drug manufacturers package & go to market with both 0.5mL standard & 1 mL long glass syringes. Generics manufacturers of low molecular weight heparin want to ensure that end users have the same experience as the drug product offered by the branded biopharmaceutical manufacturers. Because many prefilled syringe drugs are delivered in doses of 1mL or less, the 0.5mL & 1mL NovaGuard SA Pro safety systems address customer needs with an innovative technology platform that meets their dosage requirements and provides the same end-user experience.
About the Award: The Best Technologies Innovation Award recognizes cutting-edge technologies, either new technologies or a novel implementation of existing technologies that have the potential to change the way pharma/bio companies operate.
Efficiency Champion: Quartic.ai, First in market Bayesian AI based DoE and Bayesian Batch Optimizer
Bayesian DOE accelerates product development and scale up - reduces the time of developments, number of batch runs, allows higher accuracy QTPP to be developed, and speeds up scale dependent tech transfer. Bayesian optimizer overcomes the challenge of lack of data available for machine learning technology use in bioprocessing.
About the Award: The INTERPHEX Efficiency Champion Award is given to an exhibitor whose product or service understands the need for integrated efficiencies in processes and supports the fast pace of the pharma/bio industry—whether in research, development, or commercial-scale production.
Biotech Innovation: Catalent, GPEx® Lightning – Next Generation Cell Line Engineering to Speed the Path to Clinic
In July 2021, Catalent launched GPEx® Lightning, a novel cell line engineering technology designed to further shorten development timelines for biologic drugs. GPEx Lightning is built upon Catalent’s GPEx cell line development technology, which is established as a means of generating genetically stable, high titre cell lines. Leveraging Catalent’s proven GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, GPEx Lightning combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines. To date, Catalent’s suite of GPEx technologies have been proven in 15 commercial products, and there are more than 125 ongoing clinical trials with therapeutic candidates developed using the technology.
About the Award: The Biotech Innovation Award acknowledges an exhibitor’s innovative application to a given product or service that not only addresses an industry need but does so in such a way as to exceed previous standards or applications—thereby making the given process simpler, smoother, or easier to navigate.
For over 40 years, INTERPHEX has been, and continues to be, the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization”. Sponsored by the Parenteral Drug Association (PDA), the event is based in New York and brings over 11,000 global industry professionals and 625+ industry leading suppliers together to “Learn it, Experience it, Procure it” through a unique combination of exhibits, demonstrations, partnering opportunities, networking and no cost technical conference to leverage quality, efficiency and cost effectiveness in today’s ever-changing global market. INTERPHEX offers annual domestic and international industry events and educational opportunities around the world. INTERPHEX and INNOPHEX together, offer the very latest intelligence, cutting-edge technologies and state-of-the-art innovation throughout the product development life cycle. Follow INTERPHEX on Facebook, LinkedIn, Instagram, YouTube, and Twitter. IPX Blog continues the learning beyond the show floor. For more information, visit www.INTERPHEX.com.
About American Pharmaceutical Review
American Pharmaceutical Review is the leading review journal for business and technology in the pharmaceutical industry throughout North America. Each issue offers 30,000 readers unbiased editorial coverage of the latest developments in: drug delivery, information technology, research & development, analytical development and control, equipment and facility manufacturing and regulatory affairs. With its in-depth coverage, American Pharmaceutical Review is able to keep its readership of senior executives, technical personnel, scientists, and others fully abreast of the latest trends and developments in the process of pharmaceutical manufacturing. American Pharmaceutical Review is published bi-monthly in January/February, March, April, May/June, July/August, September/October and November/December. Each issue reaches over 30,000 key decision makers for the pharmaceutical industry in North America. For questions or for advertising information on American Pharmaceutical Review please contact firstname.lastname@example.org.
About Pharmaceutical Outsourcing
Pharmaceutical Outsourcing is the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmaceutical Outsourcing is published quarterly with a Company Focus issue published in October. Each issue reaches over 20,000 key decision makers involved in outsourcing and contract services for the pharmaceutical and biopharmaceutical industries in North America. For questions or for advertising information on Pharmaceutical Outsourcing please contact email@example.com.