Matriks Biotek® produced SHIKARI® Q-REMS and
S-AIR as the first ELISA kits for the biosimilar of Infliximab,
CT-P13 (Remsima®)and now also offers to develop custom ELISA kits for your
biosimilars or biologics on contract manufacturing basis depending on the
molecule provided. Matriks Biotek® is the first company to commercialize
SHIKARI® ELISA kits for biological drug testing to measure trough levels
and anti drug antibodies (immunogenicity) since 2008.
Pricing for SHIKARI® Q-REMS and S-AIR is 450 Euro plus shipment per kit for a limited time until the end of September 2016.
Do not forget to add code "Q-REMS" in your purchase order in your e-mail to info@matriksbiotek.com
Ask for all 23 SHIKARI® ELISA kits for biological drug testing or for your custom needs ..
By
the mid of June with these new additions there will be total of 24 kits for
biological drug testing for 12 different drugs widely used for treatment of
diseases, such as inflammation, cancer and allergic disorders and osteoporosis.
As with all therapeutic
proteins, there is a potential for immunogenicity. In order to benefit from
your most valuable biological drug we recommend to measure trough levels along
with anti-drug antibodies together from samples taken just before the administration
of following dose by SHIKARI® ELISA kits.
We
are hoping that patients, clinicians and biosimilar drug producers benefit from
our products at most. Others to come soon...
Nivolumab is a humanized
IgG4 monoclonal anti-PD-1 antibody. Its molecular weight is 146 kDa. Mechanism
of Action: Programmed death 1 (PD-1) receptor is a type I membrane protein of
268 amino acids. PD-1 is expressed on the surface of activated T cells, B
cells, and macrophages. The binding of PD-1 and its ligands (PD-L1 and PD-L2)
on a tumor cell contributes to inhibition of active T-cell immune surveillance
of tumors. By inhibiting the PD-1 receptor from binding to its ligands,
nivolumab reactivates tumor-specific cytotoxic T lymphocytes in the tumor
microenvironment and reactivates anti-tumor immunity. Clinical Dose Selection:
The selection of nivolumab dose and schedule of 3 mg/kg Q2W was based on the
observed clinical safety and efficacy from 306 patients in trial MDX1106-03
across different dose levels and tumor types.
Immunogenicity:
As with all therapeutic proteins, there is a potential
for immunogenicity. Of 532 patients who were treated with OPDIVO 3 mg/kg every
2 weeks and evaluable for the presence of anti-nivolumab antibodies, 67
patients (12.6%) tested positive for treatmentemergent anti-nivolumab
antibodies by an electrochemiluminescent (ECL) assay. Neutralizing antibodies
against nivolumab were detected in five patients (0.9%). There was no evidence
of altered pharmacokinetic profile or toxicity profile with anti-nivolumab
binding antibody development. Of 105 patients who were treated with OPDIVO in
combination with ipilimumab and evaluable for the presence of anti-nivolumab
antibodies, 23 patients (21.9%) tested positive for treatment-emergent
anti-nivolumab antibodies by an ECL assay. Neutralizing antibodies against
nivolumab were detected in one patient (1%). There was no evidence of altered
toxicity profile with anti-nivolumab antibody development. The detection of
antibody formation is highly dependent on the sensitivity and specificity of
the assay.
