Albumins
Akron Biotechnology LLC Human Serum Albumin (HSA) 25% Solution, GMP Grade, 100mL Vial, AK8228-0100
Akron’s Human Serum Albumin (HSA) 25% Solution is manufactured following relevant cGMP guidelines for blood-derived ancillary materials. Product Features:Raw Material• Human Plasma from US-licensed plasma donation centers• Donor screening and virus testing per 21 CFR 610.40• cGMP Raw Material – Cohn Fraction VManufacturing• Type II eCTD DMF (#019354) on file with FDA• Formulated with WFI (water for injection)• Does not contain stabilizers Caprylate or N-Acetyl-L-Tryptophanate• No animal-derived materials are used in the manufacture of this product• Sterile microfiltration followed by aseptic fillingStability• 24-month shelf life• Store at 2-8 °C• Transport with cold packsFor Use StatementFor research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.
Akron Biotechnology LLC Human Serum Albumin (HSA) 25% Solution Closed System Solutions (CSS)TM, GMP Grade, 100 mL Bag, AR1037-0100
Akron’s Human Serum Albumin (HSA) 25% Closed System Solutions (CSS)™ is manufactured following relevant cGMP guidelines for blood-derived ancillary materials. Product Features:Raw Material• Human Plasma from US-licensed plasma donation centers• Donor screening and virus testing per 21 CFR 610.40• cGMP Raw Material – Cohn Fraction VManufacturing• Type II eCTD DMF (#019354) on file with FDA• Formulated with WFI (water for injection)• Does not contain stabilizers Caprylate or N-Acetyl-L-Tryptophanate• No animal-derived materials are used in the manufacture of this product• Sterile microfiltration followed by aseptic fillingStability• 24-month shelf life• Store at 2-8 °C• Transport with cold packsFor Use StatementFor research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.