While many associate the month of November with Men’s Health Awareness, it is also important to shine the spotlight on Lung Cancer Awareness Month. According to the American Lung Association, lung cancer is the leading cause of death in both men and women in America. Lung cancer is primarily caused by smoking, with 80-90% of fatal cases caused by the habit in both men and women. However, exposure to harmful chemicals or the presence of certain inherited genetic markers may also trigger the onset of this terrible disease. Patients that are considered high risk do have the option for regular screenings. If a doctor does suspect abnormalities in a patient’s lung after a low-dose CT scan, additional testing, such as a biopsy, will determine the diagnosis. When lung cancer is detected early, the mortality rate can decrease by 14-20 percent for those who are high-risk. Symptoms: Chronic cough Shortness of breath or wheezing Coughing up blood Frequent lung infections like bronchitis or pneumonia Causes: Smoking Radon Air pollution Prevention: Don’t smoke or quit smoking Avoid secondhand smoke exposure Test your home for Radon and other harmful chemical exposures Companion diagnostics are one tool that provides insights into the early diagnosis, prognosis, therapeutic effectiveness, and monitoring of cancer through molecular testing. LaunchWorks partners with companies to develop and optimize cancer diagnostic products for commercial, large-scale manufacturing. LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products [...]
The season of Respiratory Syncytial Virus, better known as RSV, is here. This respiratory illness is most prevalent in young children but can also be found in adults with underlying diseases such as heart or lung disease. According to the CDC, RSV can ultimately be the root cause of more severe respiratory infections like bronchiolitis and pneumonia. Transmission An already infected person coughing or sneezing Direct contact with the virus Kissing a child’s face Touching a surface then touching your face Symptoms Runny nose Decreased appetite Coughing Wheezing Fever Sneezing Prevention Wash hands often with soap Avoid close contact with sick people Limit time spent in contagious setting during RSV activity Clean and disinfect surfaces RSV, like other common respiratory viral infections, can be detected using molecular assays to identify the presence of RNA targets in clinical respiratory specimens with high sensitivity and specificity. LaunchWorks’ One-Step RT-qPCR Master Mix was designed for sensitive and reproducible detection of RNA and/or DNA targets in a single or multiplexed RT-qPCR reaction. The 2x formatted Master Mix can run multiplexed reactions including Flu A, Flu B, RSV and COVID-19. Additionally, Launchworks Viral Transport Media (VTM), specimen collection, and sample prep products are designed to get your respiratory clinical sample to the diagnostic lab, without degradation. LaunchWorks CDMO partners with companies to develop and optimize diagnostic products for commercial, large-scale manufacturing. Our company provides an expansive list of services, from creating custom pilot lot kits for high complexity products [...]
November is Men’s Health Awareness Month. Although there are many stigmas attached to men’s health, LaunchWorks is proud to partner with companies aiming to change that mindset and improve the lives of men’s health around the world. According to Movember, 1 in 2 men will be diagnosed with cancer in their lifetime. Testicular cancer is the most common cancer in males aged 15-39. Prostate cancer often has no symptoms until it advances, making it the second most common cancer for men. Testing for these cancers includes genomic testing, genetic testing, biopsy of the area or of the Lymph node to determine whether the cancer has spread to additional parts of the body. Even with increasing survival rates, early detection is the key to saving a life and maintaining quality of life. Companion diagnostics is one tool providing insights into the early diagnosis, prognosis, therapeutic effectiveness, and monitoring of cancer through molecular testing. LaunchWorks CDMO partners with companies to develop and optimize cancer diagnostic products for commercial, large-scale manufacturing. LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products to fully commercialized kitting and fulfillment. LaunchWorks provides testing services that include real-time and accelerated product aging and package testing. Additionally, cold chain packaging for custom cold chain shipping needs can be developed and validated through our affiliate company, Cryopak. LaunchWorks is proud to support companies in the fight to improve men’s health and honor those that have lost the battle. For more information about how LaunchWorks supports early [...]
DNA/RNA extraction is a vital part of biotechnology. It gives scientists the capability to research and study genetic diseases and viruses such as Parkinson’s, Breast Cancer, Influenza, COVID-19 and many more. Although we are still uncovering new things in the biomedical field, DNA/RNA extraction kits further the development in diagnostics and genomics. The LaunchWorks xNetic Viral RNA/DNA Extraction Kit allows for a one-step magnetic bead-based extraction and purification of Viral RNA in less than 15 minutes. Product Highlights: No heating, centrifugation or vortexing No Proteinase K or carrier RNA required No cold chain storage requirements for any test components Samples from swab solutions (VTM and MTM), serum/plasma, saliva, and other cell-free bodily fluids No expensive benchtop equipment needed for manual processing Our technology has been validated for a variety of commercially available automated platforms with results that exceed performance compared to industry standards. The LaunchWorks xNetic Viral RNA/DNA Extraction Kit is a cost-effective solution that requires less components, less time and less capital investment for diagnostic sample preparation. For example, the performance of the LaunchWorks xNetic Viral DNA/RNA Extraction Kit showed high extraction efficiencies at 99 – 100% recovery for low SARS-CoV-2 copy numbers ranging from 1 – 100 copies/µL. LaunchWorks CDMO partners with companies to develop and optimize diagnostic products for commercial, large-scale manufacturing. LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products to fully commercialized kitting and fulfillment. LaunchWorks is proud to assist companies combat the spread of diseases and viruses through the utilization of [...]
Now that school is back in full swing and the weather is turning, flu season is creeping around the corner. This is the perfect opportunity to stock up on products to help combat the spread of the Influenza virus. According to the CDC, children younger than 18 are twice as likely to develop a symptomatic Flu virus infection than adults 65 and older. During a respiratory illness outbreak in a closed setting, like classrooms, molecular diagnostic testing determines if the influenza virus is the cause of the outbreak. Molecular assays identify the presence of Influenza viral RNA in respiratory specimens with high sensitivity and specificity. LaunchWorks One-Step RT-qPCR Master Mix was designed for sensitive and reproducible detection of RNA and/or DNA targets in a single or multiplexed RT-qPCR reaction. The 2X Master Mix can run multiplexed reactions including Flu A, Flu B, RSV and COVID-19. Additionally, Launchworks Viral Transport Media (VTM) and specimen collection products are designed to get your respiratory clinical sample to the diagnostic lab, without degradation. The LaunchWorks Viral Transport Media is listed per FDA guidance, “Enforcement Policy for Viral Transport Media during the Coronavirus 2019 (COVID-19) Public Health Emergency.” LaunchWorks CDMO partners with companies to develop and optimize diagnostic products for commercial, large-scale manufacturing. LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products to fully commercialized kitting and fulfillment. LaunchWorks is elated to support those in the fight against the influenza virus. For more information about how LaunchWorks supports the fight [...]
October means it’s Breast Cancer Awareness Month! Early detection for any type of cancer is essential to patient health. Treatment is more likely to be successful and less intrusive, the sooner detection occurs. Breast cancer is no exception. According to the American Cancer Society, the death rate among women with breast cancer decreased by 40% from 1989 to 2017. This decrease is attributed to improvements in early intervention. Although some women don’t experience any symptoms at all, it is still suggested that at-risk patients get annual breast imaging, some of which may result in the need for a biopsy. There are many tools available to study biopsies. Molecular testing is one of the tools providing insights into the early diagnosis, prognosis, therapeutic targeting, and monitoring of cancer. LaunchWorks CDMO partners with companies to develop and optimize cancer diagnostic products for commercial, large-scale manufacturing. LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products to fully commercialized kitting and fulfillment. LaunchWorks is proud to support those in the fight against breast cancer and honor those that have lost the battle. For more information about how LaunchWorks supports early breast cancer detection, contact us here. LaunchWorks is: FDA Registered ISO 13485:2016 Certified cGMP Compliant Full-Service from Development to Commercialization Contract manufacturer
LaunchWorks and Canadienzyme, a biotech spin-off company by two McGill University scientists, announced their collaboration to produce a new RT-qPCR Master Mix. Canadienzyme stepped in to help Canada’s national efforts due to a shortage of tests amid the Coronavirus pandemic. In doing so, they created a made-in-Canada RT-qPCR testing reagent that works as well as international versions on patient samples. This new Master Mix provides a domestic supply in Canada and increases available inventory in the U.S. “Prior to COVID-19, there were no made-in-Canada RT-PCR testing solutions. Seeing the need; we stepped in to make these tests domestically so Canadians could be tested reliably on a broad scale,” said Dr. Martin Schmeing, CEO of Canadienzyme. “These tests are designed not just for the current pandemic, but will also equip Canada to respond quickly to other future challenges to the health of Canadians. We anticipate that the Master Mix can be applied for use in most, if not all, clinical diagnostic PCR testing applications.” “By leveraging our commercial expertise with Canadienzyme’s scientific innovation, we were able to launch the Master Mix in record speed and increase access to a much-needed product,” says Celine Barakat, General Manager of LaunchWorks. “By collaborating directly with inventors and scientists, we’ve proven that we can bring innovative life science solutions to market quickly and efficiently.” The new RT-qPCR Master Mix developed by Canadienzyme is now available through LaunchWorks in the US and Canada. The two companies will continue to work together to explore other diagnostic products and to bolster Canadian innovation and [...]
LaunchWorks has increased its filling capacity for the production of diagnostic test kits with the addition of new automation equipment at its Beverly, MA and Anjou, Canada facilities. The expansion is part of LaunchWorks response to help meet the world’s public health needs in disease diagnosis and the fight against COVID-19. With the addition of the new filling automation equipment, LaunchWorks has the functionality and capacity to produce up to 500,000 microtubes or transport media tubes per week. The new automation also improves the quality process by increasing the reproducibility of vial filling. “Our new suite of filling and capping machines will be easily redeployed for different formulations, allowing us to reduce the cost of manufacturing for customers,” says Celine Barakat, General Manager of LaunchWorks. “This increased capacity reinforces our commitment to support the world’s changing needs during the pandemic, and, beyond that, the growing molecular diagnostics market.” Originally formed within Enzymatics in 2009 and now in two locations (Beverly, MA and Anjou, Canada), LaunchWorks has evolved over the past 12 years to become an ISO 13485 certified company that is FDA Registered. Integreon Global acquired LaunchWorks in 2017, and has since worked to add new service offerings, including embarking on a filing automation program designed to help its customers be more competitive. A significant portion of the company’s recent efforts has revolved around the response to the COVID-19 crisis. Please contact us for more information or to get started on a project.
LexaGene Holdings Inc announced another milestone in its journey to commercially launch flagship analyzer product MiQLab before the end of September - the hiring of LaunchWorks as its contract manufacturer. LaunchWorks is an FDA registered, ISO 13485 certified, cGMP compliant group specializing in manufacturing consumables for life science firms, LexaGene said. It will manufacture the assay panels and buffer sets used in LexaGene's fully automated MiQLab system. "LaunchWorks can currently manufacture enough products to easily support our commercial launch and have the facilities to scale their production to meet any demands that we require. I am very impressed by their facilities, high caliber staff, and their ability to scale their operations to meet our needs as we grow," Dr Jack Regan, LexaGene's CEO and founder, told investors in a statement. MiQLab is a fully automated genetic analyzer designed to deliver reference-quality data at the point-of-need and can return results in about one hour. LexaGene says the technology can be used in multiple billion-dollar markets, including human and veterinary diagnostics as well as food safety testing. "This is an extremely exciting time for LexaGene. Our initial hires in sales are working out exceedingly well and we are in the home stretch for manufacturing and qualification. By the end of next month, we expect to begin selling and fulfilling delivery of our first units, which will be a huge milestone for the company," added Daryl Rebeck, LexaGene's president and co-founder.
Like many businesses, LaunchWorks was thrown for a loop when the COVID-19 pandemic hit, but not in the same way as some other manufacturers. The company was already on a strong growth trajectory for 2020, but when shelter-in-place mandates were announced, access to doctors’ offices limited the activity of most of the existing customer base. The company was able to harness its strengths to quickly pivot by promoting and expanding COVID-19 test kit manufacturing capabilities. As a result, LaunchWorks anticipates tripling its size this year. Automation is a key factor in scaling up to serve clients. Expanding that quickly to help meet the country’s public health needs is not a simple task. The company focused on a combination of long-term industry supplier relationships, innovative thinking and automation solutions. LaunchWorks already utilized automation, but adding new functionality and additional capacity for the COVID-19 efforts helped move from producing 75,000 transport media tubes a week to an anticipated 1 million per week. […]