Dear Valued Client, Providing our customers with high quality materials to produce the next generation of cell and gene therapies while providing world-class partnership and support is at the heart of our business. With that in mind, I would like to share that AllCells is categorized as an essential business and will be providing products and services as COVID-19 continues. In accordance with the AUTHORITY OF CALIFORNIA HEALTH AND SAFETY CODE SECTIONS 101040, 101085, AND 120175*, AllCells will begin Partial Operations beginning April 13th, 2020 and will begin collections on April 20th, 2020. SAFETY FOR EMPLOYEES, DONORS AND CUSTOMERS In March, AllCells created a task force exclusively dedicated to COVID-19. The AllCells Taskforce has worked tirelessly to keep abreast of the changing situation, both with State and Federal policies, to protect our employees, donors, and customers. The task force has defined and is adhering to the following:
CLIENT FOCUS AND CUSTOMER REQUIREMENTS We are fully aware of this unprecedented situation and will continue to meet the demands of our clients, however, in some cases, this may not be possible depending on the requests. To ensure the highest level of support, please consider the following:
CONSIDERATIONS Currently, there is no FDA approved assay for determining SARS-CoV-2 in materials other than nasopharyngeal and/or oropharyngeal swabs. Currently, there is no access to Donor testing for the virus that is not linked to medical use. There is no donor or product testing currently indicated for HCT/Ps for influenza by any agency for tissue donation. There are no current recommendations by the FDA, AABB or FACT for the testing of tissue/blood donors for SARS-CoV-2 for transplant purposes so there is not expected to be any recommendation or new requirements for clinical grade testing. Additions to our DHQ (donor history questionnaire) exclusions for travel to known hotspots, as they emerge (such as Europe, Iran, South Korea, China, Washington State, California, New York State within 14 days) and other donor screening documents will be made to assess whether the donor currently has (fever, symptoms), has been in known contact with someone diagnosed with COVID-19 or suspected of being in contact with someone with COVID-19. Additionally, we will be instituting additional follow up interviews with donors before and after collection to mitigate risk. CONCLUSION On behalf of AllCells, I would like to thank the many employees, customers and stakeholders for their persistence, inspiration, loyalty and cooperation in the fight against COVID-19. For further information regarding a need to order Research Grade or Clinical Grade products, or to reschedule a current order, please contact: Customer Success at orders@allcells.com | 1-510-726-2700 | www.allcells.com
Sincerely, |
Valerie Goodwin-Adams |
*For purposes of this Order, individuals may leave their residence to work for or obtain services at any “Healthcare Operations” including hospitals, clinics, dentists, pharmacies, pharmaceutical and biotechnology companies, other healthcare facilities, healthcare suppliers, home healthcare services providers, mental health providers, or any related and/or ancillary healthcare services. “Healthcare Operations” also includes veterinary care and all healthcare services provided to animals. |