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.
assisTek Inc | June 21, 2022
assisTek, based in Doylestown, PA, has announced its latest partnership with Philadelphia based Strados Labs. Strados Labs is known for their creation of cutting-edge smart technology medical devices for respiratory illnesses.
assisTek, has been a longtime leader in the eSource industry across various therapeutic areas, over 900+ Global clinical Trials and offers an array of services for the electronic collection of clinical data. Their technology offerings include eCOA, ePRO, eConsent, BYOD modules and an extensive reputation for their custom solutions to support clinical trial teams worldwide. "We are very excited to announce this partnership and are looking forward to working together with Strados to provide another way for clinicians and patients to gather novel information during their trials. By making the integration seamless into our current eDiary offerings, this paired technology will allow for better patient engagement and more efficient information gathering, with the ultimate goal of improved data for cures and treatment of these conditions," explains Richard Gastineau, CEO of assisTek.
Strados Labs is a medical technology company developing smart sensor platforms that utilize machine learning and proprietary algorithms to detect and predict compounding conditions associated with serious, chronic respiratory diseases to improve the lives of patients globally. "We are grateful and proud to solidify our partnership with assisTek. They have been a leader in integrating technology and data collection in clinical trials for over 20 years," said Strados Labs Director of Business Development, Shane Krauss. "We look forward to working with their experienced and knowledgeable team in clinical trials by helping them scale their digital therapeutics using our clinically validated measures for wheeze, cough, and other adventitious breath sounds, or CABS—which is something no other cleared device can measure." The Company developed a first-of-its-kind smart sensor platform for respiratory health, RESP®. Strados recently received FDA Class II 510(k) clearance for home use of its first product, RESP®, its second FDA clearance in less than 18 months. RESP® was also granted a CE Mark late last year. The Company is developing a robust pipeline algorithm to support and address other chronic diseases, as well as chronic disease management pathways. Strados will continue to target asthma, COPD and infectious respiratory diseases (COVID, RSV, and more)—with plans to add heart failure and pediatrics later this year. The Company is based in Philadelphia and is a privately held company.
Glucare.Health and NovoNordisk: | June 09, 2022
GluCare.Health, one of the Middle East's leading health tech startups, has partnered with global pharmaceutical company Novo Nordisk, market leader in Diabetes & Obesity, to introduce a blueprint for the future of healthcare.
The partnership will see a 150-patient weight management pilot program that will combine new digital bio-markers, using wearable technology and devices for continuous data monitoring, with existing therapeutics. It introduces the Middle East's first value-based reimbursement model, and will be the first relationship of its kind for Novo Nordisk globally. This innovative partnership will put accountability for outcomes vs. costs on the provider, rather than on the insurers or patients.
The 6-month program, which begins in September, is open to people with obesity who meet certain criteria. Patients will receive an unparalleled level of in-patient and data-driven remote care, with a multidisciplinary clinic team having continuous access to all patient data through an intelligent analytical platform. If patients do not lose at least 10% of their body weight by the end of the program, GluCare.Health and Novo Nordisk will cover all or a portion of the cost under the value-based reimbursement pilot. GluCare.Health is also committed to transparency when it comes to reporting results of the program.
With one in three adults affected by obesity in the UAE, GluCare.Health's Co-Founder and Managing Director, Dr. Ihsan AlMarzooqi, says that the blueprint for care has the potential to not only save many lives but the UAE economy billions of dollars in costs and lost productivity.
"When patients with chronic conditions are not supported properly, it can have a devastating impact on those individuals and their families. Additionally, the cost of treating the health consequences of obesity to the UAE economy alone is approximately $3.6 billion annually. Traditional models of care remain woefully limited when it comes to outcomes. This partnership allows us to embed Novo Nordisk's advanced therapeutics into a companion platform like GluCare.Health, which enhances its efficacy dramatically."
The first hybrid Digital Therapeutics (DTx)+Human vertically integrated diabetes platform of its kind in the world, GluCare.Health is reinventing metabolic care and transforming lives. Conceptualized in the UAE and opening the doors to its state-of-the-art 10,000 sq foot Dubai clinic in September 2020, it is the world's first healthcare provider to empower both clinicians and patients through Remote Continuous Data Monitoring as part of its standard model of care, an innovative and highly personalized 'continuous healthcare' approach that provides a comprehensive and real-time view of patients. As part of its unique model, GluCare is also an early adopter of - and the region's first clinic to use - Digital Therapeutics (DTx), combining it with wearable and smart technology, data analytics, unique in-clinic workflows, and a caring and connected expert care team. Applying technology as a humanizing force, GluCare.Health's team partners with patients and their families, giving them the tools, knowledge, and continuous support to live longer, healthier, and more fulfilling lives.
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. For more information, visit Novo Nordisk UAE.