Biosimilar, specifications

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

  • Purity ≥ 95% by SDS-PAGE and ≥ 95% monomer by analytical SEC
  • Endotoxin ≤ 1.0 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.

Natalizumab SDS Gel
Trastuzumab SDS Gel