Background: Bioassays are used to identify the pharmacological activity of new or chemically unknown compounds, as well as their undesirable effect, including toxicity. Biological assays are also required to ensure the quality, safety, and efficacy of recombinant biologics to confirm its biosimilarity to its originator. In the present study, analytical similarity between the biosimilar and its innovator is established by in vitro bioassays.
Objective: The objective of this study was to show the comparative in vitro characterization of the recombinant insulin aspart from BioGenomics with its originator insulin aspart, using relevant biological assays.
Methods: In vitro assays such as receptor binding, receptor autophosphorylation, glucose uptake, and mitogenic potential were analyzed for biological characterization of BioGenomics recombinant insulin aspart (BGL-ASP) manufactured by BioGenomics Limited and NovoRapid as the reference medicinal product (RMP) manufactured by Novo Nordisk. Insulin receptor binding was studied by a state-of-the-art method, surface plasmon resonance (SPR) for biomolecular interactions. The receptor autophosphorylation assay measures the phosphorylated insulin receptor in cell lysates. The glucose uptake assay measures the uptake of glucose by 3T3-L1 cells in the presence of insulin. Lipogenesis was studied in treated 3T3-L1 cells by detecting the accumulation of lipid droplets in the cells. Mitogenic effect was studied by cell proliferation assay using MCF-7 cells. A rabbit bioidentity test was performed by measuring the sudden decrease in blood glucose in the presence of insulin.
Results: The binding studies showed that the affinity of BGL-ASP was highly comparable to NovoRapid. Insulin receptor autophosphorylation, glucose uptake, and lipogenesis demonstrated high similarity to the RMP. The mitogenic assay for BGL-ASP did not show any proliferative effect and was comparable to the RMP. The in vivo bioidentity test showed that the BGL-ASP is highly similar to the innovator, NovoRapid.
Conclusion: The biological characterization studies of BGL-ASP demonstrated high binding and functional similarity to NovoRapid.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/s40259-023-00607-4 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Efficacy, safety and treatment satisfaction of transition to a regimen of insulin degludec/aspart: A pilot study.
World J Diabetes
January 2025
Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Background: There is a lack of clinical evidence on the efficacy and safety of transitioning from a thrice-daily pre-mixed insulin or basal-prandial regimen to insulin deglu-dec/aspart (IDegAsp) therapy, with insufficient data from the Chinese popu-lation.
Aim: To demonstrate the efficacy, safety, and treatment satisfaction associated with the transition to IDegAsp in type 2 diabetes mellitus (T2DM).
Methods: In this 12-week open-label, non-randomized, single-center, pilot study, patients with T2DM receiving thrice-daily insulin or intensive insulin treatment were transitioned to twice-daily injections of insulin IDegAsp.
Equivalence of Biosimilarity in Pharmacokinetic and Pharmacodynamic Properties of Recombinant Human Insulin Aspart.
Clin Pharmacol Drug Dev
January 2025
BGL, BioGenomics Ltd, Maharashtra, India.
Insulin aspart, a rapid-acting analog, achieves faster subcutaneous absorption than regular insulin. This study aimed to demonstrate equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Recombinant Human Insulin Aspart from BioGenomics Limited (as test) and Novo-Nordisk (as reference) in healthy adult males. This was a double-blind, randomized, cross-over study, assessing PK and PD parameters under fasting conditions.
View Article and Find Full Text PDFLong-term blood glucose control via glucose-activated transcriptional regulation of insulin analogue in type 1 diabetes mice.
Diabetes Obes Metab
January 2025
National Engineering Research Center for Biomaterials, College of Biomedical Engineering, Sichuan University, Chengdu, Sichuan, People's Republic of China.
Aim: To achieve glucose-activated transcriptional regulation of insulin analogue in skeletal muscle of T1D mice, thereby controlling blood glucose levels and preventing or mitigating diabetes-related complications.
Materials And Methods: We developed the GANIT (Glucose-Activated NFAT-regulated INSA-F Transcription) system, an innovative platform building upon the previously established intramuscular plasmid DNA (pDNA) delivery and expression system. In the GANIT system, skeletal muscle cells are genetically engineered to endogenously produce the insulin analogue INSA-F (Insulin Aspart with Furin cleavage sites).
Severe palmoplantar keratoderma: a cutaneous complication from sub-optimally controlled type 2 diabetes.
Endocrinol Diabetes Metab Case Rep
January 2025
Summary: Palmoplantar keratoderma (PPK), characterised by excessive epidermal thickening of the skin on the palms and/or plantar surfaces of the feet, can be hereditary or acquired. Here, we report a case of a 53-year-old woman with a history of sub-optimally controlled diabetes mellitus presenting with fevers and decreased Glasgow Coma Scale (GCS) to a tertiary hospital. She was diagnosed with diabetic ketoacidosis (DKA), with blood glucose at 40 mmol/L and ketones at 7 mmol/L, in the setting of a methicillin-sensitive Staphylococcus aureus necrotising soft tissue back infection.
View Article and Find Full Text PDFRegular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis.
Syst Rev
January 2025
Centre for Clinical Intervention Research, Copenhagen Trial Unit, Capital Region of Denmark, Copenhagen, Denmark.
Background: Type 1 diabetes is a serious, chronic disorder with an increasing incidence among children and adolescents. Glycemic control in individuals with type 1 diabetes is better managed through a basal-bolus regimen with either regular human or rapid-acting insulin analogues administered as a bolus at mealtimes. Rapid-acting insulin analogues have been hypothesized to cause optimal glycemic control and less risk of hypoglycemic episodes compared to regular human insulins.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!