Biosimilar, specifications

Product Specifications and IMPACT I Testing on Purified Biosimilars (RUO)

  • Purity > 95% by SDS-PAGE and ≥ 98% monomer by analytical SEC
  • Endotoxin ≤ 0.5 EU/mg as determined by the LAL method
  • Manufactured in an animal-free facility using protein-free, animal-origin-free cell culture media
  • Ultra-low levels of leached protein A
  • Sterile filtered and formulated in Leinco’s in vivo grade PBS pH 7.2 containing no K or Ca, additives, preservatives, or carrier proteins
  • Many research applications, including FC, ELISA, IHC, FA, PK and potency assays

IDEXX IMPACT I (PCR-based) Mouse Pathogen Profile for Purified Biosimilar Abs

Mycoplasma sp. Mouse adenovirus 1 (MAV1) Lactate dehydrogenase-elevating virus (LDEV)
Mycoplasma pulmonis Mouse adenovirus 2 (MAV2) Mouse kidney parvovirus (MKPV)
Sendai virus Murine norovirus (MNV) Hantaan Virus
Mouse hepatitis virus (MHV) Reovirus 3 (REO3) Mouse cytomegalovirus (mCMV)
Pneumonia virus of mice (PVM) Mouse rotavirus (EDIM) K virus
Minute virus of mice (MVM) Ectromelia virus Mouse thymic virus (MTV)
Mouse parvovirus (MPV) Polyomavirus Corynebacterium bovis
Theiler’s murine encephalomyelitis (TMEV) Lymphocytic choriomeningitis virus (LCMV) Corynebacterium sp.

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