Ingenuity BioSciences

About Us

Ingenuity BioSciences is built on the complementary strengths to deliver Integrated Service Model for Drug Development , also bringing a strong synergy in offering a comprehensive bioanalytical solution to therapeutic and biosimilar development.

Veeda Clinical Research brings a world-class clinical trial organization. Somru Bioscience brings in scientific and regulatory expertise in the area of bioanalysis, which includes custom reagent development and qualification, method development and validation, and pre-clinical/clinical sample analysis.

OUR QUALITY

Quality is at the heart of everything we do. Ingenuity is the synergy of two companies devoted to delivering quality . Ingenuity can craft a thorough solution that encompasses the breadth of therapeutic development, from characterization to post-marketing surveillance. At each step of the way, we utilize innovative approaches into offering solutions designed for optimal success.

Ingenuity is led by an experienced management team, comprised of leaders from both companies.
The extensive experience from both companies include innovative scientific expertise, experienced on global biosimilar regulations, and a determined focus on client and patient-oriented quality to deliver better results.

SERVICES

Pharmacokinetics

Ingenuity offers well characterized, fully validated, and documented PK/PD assays. Our goal is to deliver reliable results in compliance with GLP / GMP regulations and in accordance with international regulatory standards (FDA, EMEA, ICH).

Immunogenicity

Ingenuity recognizes the importance of providing a highly reliable and fully characterized immunogenicity assay. We demonstrate a full understanding of interference and cross-reactivity unique to each molecule.

Biosimilar Characterization

Ingenuity offers a wide range of biocomparability testing solutions so that you can test your biosimilar early in the development process and minimize the risk of failure during late phases of the drug development.

Biomarkers

The use of biomarkers is increasingly becoming a requirement for the successful approval of therapeutics. Ingenuity can develop and validate biomarkers in the appropriate context of use as a part of the overall drug development strategy.

Neutralizing Antibodies

Ingenuity can detect neutralizing antibodies using cell-based assay based on the drug’s mechanism of actions such as cell proliferation, cell viability, cell signaling, receptor activation, and by measuring various downstream proteins.

BioNMR

Ingenuity BioSciences partners with Clearsynth labs for BioNMR services

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Aegyris^TM

Ingenuity is a 21st century lab utilizing cloud-based enterprise tool with near real-time access for clients. The core of our technology suite is Aegyris™ - a comprehensive software solution for the bioanalytical laboratory.

Aegyris™ is designed to enable bioanalytical scientists to perform method validation, statistical analysis, and validation workflow management in a streamlined and regulatory compliant manner. The IntelliLab™ module within Aegyris is designed to streamline day to day laboratory activities involving inventory, sample tracking, and electronic laboratory notebook (ELN).

Aegyris™ meets rigorous scientific and regulatory requirements such as US 21 CFR Part 11 requirements.

Method Validations
PK, Immunogenicity, Biomarker (including multiplexing) and Biosimilar
Productivity Tools (IntelliLab)
Sample tracking using RFID
Inventory management
eLabEx (Electronic Lab notebook)

Artificial intelligence driven data analytics
21 CFR Part 11 compliance
Modules that are designed independently as micro-service for inter-operability
Scalability
Inventory management
Direct link to various LIMS or data system