Apheresis Platelet Products Offered by Versiti: a Side by Side Comparison

Apheresis Platelet Products Offered by Versiti: A Side by Side Comparison

Pathogen Reduced (PR) Platelet Large Volume, Delayed Sampling Large Volume, Delayed Sampling Conventional Platelet (LVDS) Platelet – 7D (LVDS) Platelet – 5D Description of Apheresis platelet that Apheresis platelet from which Apheresis platelet from which Apheresis platelet from which Product undergoes pathogen inactivation aerobic and anaerobic cultures aerobic and anaerobic cultures aerobic only culture (bioMerieux process (INTERCEPT™ Blood (bioMerieux BACT/ALERT®) are (bioMerieux BACT/ALERT®) are BACT/ALERT®) is obtained at System, Cerus Inc), within 24 obtained at a minimum of 48 obtained at a minimum of 36 a minimum of 24 hours after hours of collection. hours after collection. hours after collection. collection. Proportion of 50-70% 30-50% 0-1% 5-15% Versiti Inventory (5-15% after 9/1/21) (0% after 9/1/21) Starting 3/1/21 Picture of Product

Availability will Limited quantity be ending available. September 1, 2021. Pathogen Reduced (PR) Platelet Large Volume, Delayed Sampling Large Volume, Delayed Sampling Conventional Platelet (LVDS) Platelet – 7D (LVDS) Platelet – 5D Bacterial Psoralen plus UVA light Each apheresis platelet unit Each apheresis platelet unit Each apheresis platelet collection Mitigation treatment inactivates DNA in has 16 mL removed ≥48 hours has 16 mL removed ≥36 hours (‘mother bag’) has 8 mL removed Process cells preventing replication of after collection for aerobic and after collection for aerobic and ≥24 hours after collection bacteria, viruses and protozoa, anaerobic cultures. Cultures are anaerobic cultures. Cultures are for aerobic culture only and and donor lymphocytes. incubated for 12 hours prior to incubated for 12 hours prior to incubated for minimum 12 hours distribution of the product. distribution of the product. prior to distribution. Volume* 205 - 343 mL 183 – 346 mL 183 – 346 mL 199 – 350 mL Platelet Yield*‡ 3.0 – 4.1 x 1011 3.0 – 4.6 x 1011 3.0 – 4.6 x 1011 3.0 – 4.5 x 1011 * Stated ranges represent a majority of products ‡ Actual platelet yield is on each platelet at time of distribution

Expiration (day 5 days 7 days 5 days 5 days of collection = Day 0) Earliest Product Day 2 Day 3 Day 2 Day 2 is Available for Release Storage 20-24°C with agitation 20-24°C with agitation 20-24°C with agitation 20-24°C with agitation Conditions Special Attributes/Modifications CMV Equivalent (Leukocyte- Leukocyte-reduced (considered Leukocyte-reduced (considered Leukocyte-reduced (considered Seronegative reduced & CMV inactivated by CMV safe) CMV safe) CMV safe) processing) Orderable Orderable Orderable Not Orderable Irradiation Equivalent (donor lymphocytes Orderable Orderable Orderable inactivated by processing) Not Orderable Volume Orderable To be determined/awaiting ISBT To be determined/awaiting ISBT Orderable Reduction code code Washing Orderable To be determined/awaiting ISBT To be determined/awaiting ISBT Orderable code code Aliquot bags Ye s Ye s Ye s Ye s (on request) Pathogen Reduced (PR) Large Volume, Delayed Large Volume, Delayed Conventional Platelet Platelet Sampling (LVDS) Platelet – 7D Sampling (LVDS) Platelet – 5D Advantages / Disadvantages Advantages • Decreased risk of bacterial • Decreased risk of bacterial • Decreased risk of bacterial (compared to contamination compared to contamination compared to contamination compared to conventional conventional platelets. conventional platelets. conventional platelets. platelets) • Sooner availability post • 7-day shelf life without need for • Similar properties and efficacy collection. additional bacterial testing. as conventional platelets. • No need to irradiate. • Similar properties and efficacy • No need to request CMV as conventional platelets. Negative for at-risk patients. • Proactive approach to prevent potential infection from novel and/or unknown viruses, prions, and other infectious agents. Disadvantages • Unclear effect on 1-hour post- • May not reduce risk of bacterial • May not reduce risk of bacterial • May not reduce risk of transfusion platelet count contamination as much as PR contamination as much as PR bacterial contamination as increments and mean time to platelets. platelets. much as PR platelets. next transfusion. • Detection of bacteria, although • Detection of bacteria, although • Requires secondary bacterial • Potential supply constraints increased with large volume increased with large volume detection after3 days of based on requirements for sampling, is not guaranteed. sampling, is not guaranteed. storage. manufacture. • Other infectious agents (such as • Other infectious agents (such as viruses, prions or protozoa) are viruses, prions or protozoa) are not detected. not detected. Product No change from current practice. Follow institutional policy. Administration Cautions / • Avoid in patients with history • Licensure from FDA for 7-D • Required substitute to meet • Product availability will Additional of hypersensitivity reaction to platelets is required to allow patient needs. continue to decline until Information amotosalen or other psoralens. shipping out-of-state from all • Expiration can be extended up manufacturing stops on or • Potential rare risk of erythema Versiti facilities. Until licensure to 7 days if secondary bacterial around September 1, 2021. in neonates treated with is obtained, 5-D platelets will be detection testing performed. phototherapy devices that emit the only product available for a peak energy wavelength <425 shipping out-of-state. nm or have a lower bound of emission bandwidth <375 nm.