Diabetes is a chronic metabolic condition that is associated with elevated blood sugar levels and which can, over time, lead to serious cardiovascular, ocular, renal, neuronal, and metabolic complications. The prevalence of Diabetes Mellitus is increasing globally, affecting millions of people worldwide. The number of people with Diabetes is climbing closer to 500 million, primarily driven by the rise in urbanization and sedentary lifestyle. During this World Diabetes Awareness week (June 14th – 20th 2021), it becomes important more than ever to focus and emphasize on enhancing the availability of improved treatment modalities for diabetes management.
The advent of biosimilar insulins is poised to contribute in a significant manner to enable increased accessibility to the treatment, cost reduction and overall patient care.
Navitas Life Sciences supports Clinical Studies on Insulin Biosimilars
Navitas Life Sciences understands the requirement and has been at the forefront to enable the required capabilities to address the customer needs of bringing Insulin products to the market faster with the highest level of compliance to regulatory requirements.
We have understood and mastered the challenges of deploying the required infrastructure, study design, and methodology to scientifically demonstrate bioequivalence.
We have a dedicated pool of volunteers who can comply with complex clamp procedures.
The automated Infusion Pumps help in the efficient control of euglycemic status with timed dextrose infusion.
The facility, by virtue of being housed inside a tertiary care hospital, enables immediate advanced emergency medical care with swift access to the emergency specialists and multispecialty ICU.
Navitas Life Sciences has a robust library of more than 300 validated methods with the required sensitivity and has expertise in handling peptides in both LC-MS/MS
The challenges are:
- Expertise and instrumentation (Glucose analyzers, ECLIA analyzers, highly sensitive triple quad mass spec).
- Instituting precise euglycemic glucose clamp technique.
- Constant safety monitoring of subjects during the conduct of the study.
- Deployment of regulatory compliant validated method for estimation of Insulin/analogs/metabolites.
- Evaluation and choice of analytical platforms (Ligand binding assays/ Chromatographic assays).
- Overcoming the complexities associated with large molecules in general and specifically the water soluble nature of Insulin.
- Technical considerations for data analysis (Pharmacokinetic considerations, statistical considerations especially for differentiating exogenous Insulin from that of endogenous).
Understanding the requirement of the customers, Navitas Life Sciences brings you effective solutions to introduce your Insulin product faster to the market.
Navitas Life Sciences’ Biosimilar Study Experience:
- Regular Insulin Human, 30 IU per mL/Isophane Suspension 70 IU per mL
- Subcutaneous Doses of Insulin Glargine Injection 100 IU/mL & Dose 0.5 IU/kg
- Biphasic Isophane Insulin 30/70 Injection 200 IU
- Soluble Insulin Injection R 40 IU/mL; Dose : 0.3 IU/kg
5 Top ways Navitas Life Sciences supports Insulin Biosimilars to gain First-to-Market Advantage
We ensure that your biosimilar study is conducted with the highest level of compliance to regulatory requirements. With intelligent investments in technology as well as the necessary expertise and infrastructure, we can ensure that your biosimilar Insulin product is launched in the market quickly.
1) End-to-End Support: Navitas Life Sciences provides end-to-end support which includes study design, conduct, bioanalysis, data standardization and analysis, dossier preparation, regulatory submissions, and pharmacovigilance.
2) Expertise across a wide variety of studies: We have the expertise and experience to manage complicated studies and deliver high quality outputs. We have experience across a wide variety of studies involving multiple doses, different dosage forms, single and double blind, dose escalation, PK/PD end point studies, Glucose clamp studies, proof of concept and exploratory, repeat “first in man”, nutritional, special population, drug interaction, injection study, inhalation study, and many more.
3) State of the art labs: Our infrastructure and systems are setup to guarantee high-quality outputs and compliance for biosimilar companies. Our state-of-art facilities are approved by DCGI, NPRA Malaysia, and self-identified with USFDA. The facilities, systems and processes have been inspected successfully by the USFDA, WHO, ANSM, AGES, Thai FDA, NPRA, and DCGI. Additionally, many studies performed at our facilities have been submitted, evaluated and accepted across the globe, for example with Health Canada, EU member states, Indonesia, and Australia.
We are ISO 9001-2015, ISO 27001-2013 certified for both our Quality Management System and our Information Security Management System. Our Clinical laboratories performing pathology testing are accredited by the National Accreditation Board for Laboratories (NABL: ISO15189-2012) and the College of American Pathologists (CAP).
4) Euglycemic Study capabilities: Navitas Life Sciences has purpose built euglycemic clamp capabilities with experienced investigators, specially trained nursing staff with expertise in clinical execution of euglycemic clamp studies.
We have safely and successfully conducted about 272 clamps with more than half of which were extending up to 24 hours in euglycemia duration. We have a dedicated pool of volunteers who can comply to complex clamp procedures.
State of the art euglycemic clamp facility is equipped with YSI 2900 Analyzer, a 21CFR Part11 compliant instrument that provides instant high-quality audit ready glucose clamp data (results generated within 60 seconds with the precision of 2% or below). The automated Infusion Pumps help in efficient control of euglycemic status with timed dextrose infusion.
Patient Monitors, ECG Machines, Suction apparatus, oxygen cylinders and anaphylaxis kit support dynamic safety monitoring and management of the participating subjects. The facility, by virtue of being housed inside a tertiary care hospital enables immediate advanced emergency medical care with swift access to the emergency specialists and multispecialty ICU.
5) Scalable and adaptable Bioanalysis and Analytical Platforms: Our Bioanalysis and wide range of analytical platforms Including high end LC-MS/MS like Waters Xevo-TQS and AB Sciex-6500 provide adaptability and can scale to meet your insulin biosimilar studies. Built on a foundation of technology driven platforms and with global clinical operations capabilities coupled with a very competent Bioanalytical laboratory supporting biosimilar clinical trials help our customers to overcome complex clinical study challenges and help in successfully completing.
Navitas Life Sciences has a robust library of more than 300 validated methods with required sensitivity and has expertise in handling peptides in both LC-MS/MS and LBA based assay formats. NLS is a pioneer in establishing methods for insulin and its analogs on LC-MS/MS and ECLIA platforms.
|ECLIA (LBA)||INSULIN||0.160 to 7.214||ng/mL|
|C-PEPTIDE||0.188 to 7.050||ng/mL|
|LC-MS/MS||HUMAN INSULIN||0.200 to 20.000||ng/mL|
|INSULIN GLARGINE||70.000 to 2100.000||pg/mL|
|INSULIN GLARGINE M1||70.000 to -2100.000||pg/mL|
|INSULIN GLARGINE M2||70.000 to 2100.000||pg/mL|
|INSULIN ASPART||0.100 to 10.000||ng/mL|
Proficient in running stellar clinical trials, we have been supporting clinical research on likely treatment of diabetes for more than 10 years. We have conducted multiple insulin biosimilar studies in collaboration with small, medium, and large pharmaceuticals, focusing on innovation as a catalyst to bring value to all our stakeholders.