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WuXi AppTec Device Review
WuXi AppTec is a company that focuses on improving the world by testing medical devices. There are new medical devices being created constantly, but often these will fail due to lack of finances, testing issues, and recalls. That’s where this WuXi AppTec device review comes in.
What WuXi AppTec Does
The company supports medical devices with a focus on three main areas: chemistry, leadership, and partnership. They have the labs to test your medical devices and can help companies perfect their offers before attempting to get approval.
There are many steps to getting your device approved, but you can drastically improve the chances of approval if you conduct the proper testing ahead of time. This involves allowing a lab and scientists to test the device and determine if there are any weaknesses or areas that need to be improved before you apply for medical device approval.
WuXi AppTec offers services for device testing in two locations in the United States, as well as one location in China. They offer a range of services to help companies build their options for approvals. These include:
Cell and Gene Therapy
WuXi offers gene and cell therapy services as a global contract development and manufacturing organization (CTDMO). They provide aid in developing and manufacturing, as well as the commercialization of advanced biopharmaceuticals. The goal is to manufacture and test options that will help companies get their biopharmaceutical products approved and launched to market as fast as possible.
With their expertise and experience, they can expedite the process and provide testing services that are personalized to the needs of each individual client. Testing services include analytical development, lot release, materials characterization, viral clearance validation, and cell line characterization. WuXi offers testing of vaccines, protein therapies, and advanced therapies, such as cell and gene therapy.
Small Molecule Drug R&D and Manufacturing
WuXi AppTec also provides a range of R&D services. With a strong research team that has built up years of experience, the company offers:
Chemistry services. With an aim to provide fast, high-quality chemistry service, the company offers custom synthesis, discovery process chemistry, special chemistry platforms, library design and synthesis, reagent service, and compound management.
Chemistry analysis. Another service provided is the purification and impurity isolation, identification of impurities, separation, ASMS screening, pharmaceutical analysis, physicochemical characterization, and more.
Structure-based drug discovery. This service provides a range of options for drug discovery, including premium protein supply, biophysical analysis, fragment screening, and X-ray crystallography. All of these are meant to help companies create higher-quality products.
You’ll find services in preclinical development for drugs, as well as clinical drug development for those who know what they want to do but may lack the resources to create the product. Everything from safety assessments to bioanalytical services are available to help you come up with the perfect medication.
WuXi AppTec also provides clinical services as a global contract research organization. If your product is anywhere from Phase I to IV, the company can be of service to you. These include biometrics, medical affairs, early clinical trials, and clinical operations, as well as quality system management. In short, if you are looking for clinical trials, this is a good place to get started. They’ll help walk you through each process and help you get your product ready to go to market.
The process to getting anything medical through all the regulations and testing is to plan carefully from the start and ensure you do everything correctly. One wrong step could result in a rejection. This is why companies choose to hire WuXi AppTec.
Consulting with WuXi AppTec
If you’re new to the world of medical devices, but have a great idea, you may need to hire someone to help walk you through the whole process. The experts at WuXi AppTec provide medical device testing, including access to their equipment and full laboratory. This allows you to check that the device will actually pass the rigorous testing done by the FDA and other national standards.
One of the biggest benefits of consulting with this company is that the scientists they hire are all involved in global standards committees, which helps give companies the expertise they actually need. In 2020, the FDA approved a record 132 medical devices, but roughly 75% of all medical device companies never get their products to market.
Any medical company that is looking to launch to market, whether they are creating a drug, therapy, or medical device, will need some help getting there. The testing process is rigorous and it’s essential to ensure the safety of all involved. With a company like WuXi AppTec, it’s possible to have outside consultants and testing for nearly any type of medical product. This ensures the product is ready to face the testing procedures that the FDA or other governing authority will put the product through. Prior testing also improves the company’s chances of making it through the approval process and getting products to market.
If you are currently preparing a product for the healthcare industry, it may be worth considering some outside input and testing in order to prove your product. The more you can do to increase the probability of passing the testing phase, the more likely you’ll see your product for sale on shelves at some point.
LinkedIn: WuXi AppTec offers medical product creators a chance to improve their possibilities of passing FDA regulations to reach the market.