WuXi Biologics | June 06, 2022
WuXi Biologics a global CRDMO service company, announced it has successfully launched the GMP operation of its new drug product facility DP5 located in Wuxi, China. The DP5 is the ninth operational drug product facility in the global network of WuXi Biologics.
The DP5 facility features an advanced isolator filling line for continuous and steady filling services, which offers multiple volume delivery options for pre-filled syringes including 1 mL Long, 1 mL, 2.25 mL and 3 mL. The maximum filling speed can reach 400 PFS/min to support 17 million syringes of drug products manufacturing every year. The increased manufacturing capacity at DP5 allows WuXi Biologics to provide global partners with faster and more robust end-to-end drug product services for their innovative products at different scales and stages.
Compared to a traditional drug product filling line, DP5's state-of-the-art design and layout, single-use technology and automated equipment, significantly decrease the risk of contamination and maintain aseptic control required in the filling process. This process supports clients' products scale up to commercial capability and reliably delivers to patients under the highest quality standards which WuXi Biologics represents.
"Pre-filled syringes have emerged as one of the fastest-growing choices for biologics dosage form as our partners seek new and more convenient biologics delivery methods. The GMP operation of DP5, our first commercial drug product facility for pre-filled syringes, not only demonstrates our commitment to global partners, but also marks an important milestone for WuXi Biologics to become one of the global leaders in drug product CDMO services. We'll continue to enable our clients to advance innovative biologics towards clinical trials, regulatory approvals, and commercialization to benefit patients worldwide."
Dr. Chris Chen, CEO of WuXi Biologics
About WuXi Biologics
WuXi Biologics is a global Contract Research, Development and Manufacturing Organization offering end-to-end solutions that enable partners to discover, develop, and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 10,000 skilled employees in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development, and manufacturing solutions. As of the end of 2021, WuXi Biologics is supporting over 480 integrated client projects, including nine in commercial manufacturing.
ILC Dover | May 27, 2022
ILC Dover, the leading provider of spacesuits since the Apollo era, announced that it was selected to be one of two providers of Boeing's Ascent/Entry Suit for the company's Commercial Crew Program and has developed a bespoke AES spacesuit for CST-100 Starliner crews.
"We are proud to utilize our expertise to create a new AES for the Starliner spacecraft. Having worked with the Boeing team on the Starliner's landing airbags, which provide a safe, cushioned arrival to Earth from space, we understood the importance of delivering another quality product for this program."
Patty Stoll, President of Space Systems and Engineered Solutions at ILC Dover
The Boeing AES is based off ILC Dover's commercial Launch, Entry, and Abort suit, SOL™. ILC Dover worked with Boeing to tailor SOL for the Starliner spacecraft to provide protection for astronauts during the most critical phases of spaceflight, including launch, docking, re-entry and landing. With over 50 years of spacesuit experience, the AES suit was designed to provide maximum mobility to operate, enter and exit the spacecraft, as well as provide protection for astronauts in case of an emergency.
"Our success is measured by those we've helped return to Earth safely for over 50 years of space travel and we will continue to provide spacesuits and soft solutions that will keep astronauts safe in the harsh environment of space," said Stoll.
Working with ILC Dover's in-house fashion designer, the cover layer of the spacesuit was designed with a unique look for Starliner crew members.
A replica of the Starliner AES will be on display on Florida's Space Coast at the Kennedy Space Center Visitor Complex's new attraction called Gateway: The Deep Space Launch Complex. ILC Dover and Boeing worked with Adam Savage, television personality and longtime special effects designer and fabricator, to create the replica.
About ILC Dover
ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.
Digital Medicine Society | July 18, 2022
Today, the Digital Medicine Society released the Sensor Data Integrations Toolkits, four comprehensive toolkits to guide data producers, processors, and consumers to use the influx of data from the increased use of wearables and digital sensing products at scale. These resources are based on the Sensor Data Integrations project, comprised of healthcare leaders from Amazon Web Services Oracle, the Moffitt Cancer Center, Takeda, the US Department of Veterans Affairs and more. These toolkits will help realize the promise of sensor generated data to drive better decisions, faster, to improve healthcare delivery and research. The project team will conduct a demo of the toolkits during a live launch event on July 18 at 10:30 am ET, featuring Micky Tripathi, the National Coordinator for Health Information Technology at the US Department of Health and Human Services.
The surge of data from sensor technologies is far outpacing the industry's ability to collect, store, analyze, protect, and use this data effectively for patient care and research. The number of US patients using remote patient monitoring devices is expected to surpass 70 million by 2025. Between 2022 and 2028, the global market for wearable technology is expected to grow around 18.5 percent, reaching $380.5 billion. The number of unique digital endpoints being used in industry sponsored trials of new medical products increased by over 950% between October 2019 and May 2022. The number of sponsors using these products in medical product development increased from 12 to 96 in the same timespan. And while the ability to discern high-quality sensor data suitable for clinical decision making is increasing rapidly, the ability to access these data is constrained by a current dependence on individual point solutions.
"Sensor generated data, captured during people's daily lives, offer the opportunity to redefine how we measure health and disease. This opportunity powers the possibility of using high quality, high resolution flows of data to reimagine our approach to healthcare and research, leveraging more complete information to improve individual clinical decisions, decisions about the effectiveness of new medical products, and broader policy and public health decisions. DiMe's new Sensor Data Integrations Toolkits provide action-oriented resources to help data producers, processors, and consumers come together to create a sensor data ecosystem suitable for scale."
DiMe CEO Jennifer Goldsack
AWS has contributed customer feedback and technical expertise to ensure the toolkit meets the needs of today's modern healthcare system. "Across every industry, we see companies trying to accelerate their path to the cloud," said Lita Sands, Head of Solutions Life Sciences at AWS. "Timelines are getting quicker while the data collected is increasing exponentially – there is a clear and significant need for how to effectively and securely collect and use this information at scale. DiMe's new toolkits are a lifeline to organizations working with sensor data. They offer a comprehensive starting point for data producers, processors, and consumers to help build an integrated pipeline to support better and faster decision making."
The development of these toolkits builds on DiMe's previous pre-competitive initiatives, such as The Playbook, the essential guide for developing and deploying digital clinical measures to advance patient care, clinical research, and public health. The Sensor Data Integrations Toolkits go further to ensure that high quality sensor data can be used at scale to improve patient care and speed efficient medical product development.
The DiMe community is currently working on additional projects related to taking digitally generated data to scale and will be releasing additional resources over the coming months. DiMe is not only committed to creating and disseminating new digital health approaches and tools, but also sharing user experiences with the broader community. We encourage Sensor Data Integrations Toolkits users to contribute to Dime's "Resources in Action" case study hub by sharing how you are using resources to further the safe, effective, equitable, and ethical use of digital medicine to redefine healthcare and improve human health.
The leading organizations from across the global healthcare, research, and digital health innovation sectors that collaborated with DiMe to create these open-access resources are AWS, Elevance Health, Evidation, US Food and Drug Administration (FDA), Human First, Institute of Electrical and Electronics Engineers, Medable, Moffitt Cancer Center, Open mHealth, Oracle, Savvy, Takeda, and US Department of Veterans Affairs (VA).
About the Digital Medicine Society
DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs. Join us to advance the ethical, effective, equitable, and safe use of digital medicine to redefine healthcare and improve lives.