Developed by Sanofi, Soliqua 100/33 (insulin glargine & Lixisenatide injection) is indicated for the treatment of Type 2 diabetes.
AIBioTech provides drug discovery and diagnostic development organizations with a broad range of world-class laboratory services to bring new products to market.
Located in a 32,000ft² laboratory in Richmond, Virginia, AIBioTech is a comprehensive life-sciences contract research organization which provides reliable expertise and cutting-edge technologies which are not available from other companies.
An expert core laboratory, we provide consultation on experimental design and offer comprehensive services under GLP and non-GLP compliance. These services are offered individually or can be integrated to support product development from discovery-to-market with full regulatory support under FDA GLP Guidelines 21 CFR 58.
AIBioTech offers integrated programs in molecular biology: immunochemistry; protein expression and characterization; peptide synthesis and purification; mass spectrometry and other bio-analytical services; assay development and validation; microbiology, virology and biosafety testing (BSL3 facilities); clinical testing services, clinical support services, genetic identity and forensic analysis.
Contract laboratory services for biologics
AIBioTech offers a range of contract laboratory services, encompassing the discovery, development and manufacture of biologics and specialty diagnostics.
For research and GLP-grade biologics development, AIBioTech’s superior scientific knowledge, technological prowess and strict adherence to quality standards provide a critical resource for our clients.
AIBioTech’s internal biomanufacturing capabilities include research and GLP-grade:
- Therapeutic monoclonal antibodies
- Therapeutic proteins
- Recombinant proteins
- Vaccines (BSL-3)
- Gene therapies
Custom biomanufacturing support services
AIBioTech provides custom biomanufacturing support services to assist with the analytical challenges of characterizing your biologic product and assessing biosafety risks. These support services include:
- Custom potency and bioassay development and testing
- Cell bank characterization
- Protein characterization
- Stability testing of proteins and peptides
- Endotoxin analysis and residual organics
- Genetic characterization, molecular biology assays and residual DNA
- Virology, detection of adventitious agents, retroviruses, PCR assays for cell banks, viral clearance and residual host cell DNA
- Detection of replication competent viruses for gene therapies and vaccines
- Mycoplasma detection
- Lot release for safety, purity and potency
Custom assays for central laboratory testing
AIBioTech supports central laboratory testing by developing custom assays to assess the safety, efficacy and potency of biologics.
Vaccines, gene therapies, therapeutics antibodies, therapeutic proteins and peptides, and antitoxins all have unique requirements for assessing safety, efficacy and pharmacological effects (biomarkers). AIBioTech demonstrates considerable flexibility when working with sponsors or third-party managed laboratory studies, in order to provide specialized diagnostic tests. Our CAP/CLIA approved laboratories and state-of-the-art technology platforms can interface with any clinical trial testing organization.
AIBioTech can develop customized assays during the preclinical phase and adapt these assays for human studies. Alternatively, sponsor developed assays can be internalized, validated and used in human trial testing.
Customized discovery laboratory services
AIBioTech’s flexible outsourcing model allows for customized discovery laboratory services. We have a broad vision and expertise across many fields of life sciences R&D, including protein chemistry, molecular biology, immunology, and recombinant biology. AIBioTech is a leading provider of comprehensive DNA sequencing services, genome analysis and bioinformatics services. Comprehensive sequencing services include both Sanger and next generation sequencing capabilities. We work as an extension of your organization, boosting your team when internal resources are limited.
AIBioTech’s flexible outsourcing model provides collaboration, with direct access to senior scientists to manage your project, to arrive at consultative solutions. And because AIBioTech does not develop its own products, nor request that clients relinquish any intellectual property rights associated with their projects, you can be confident that our focus on quality and cost-management for your product remains unwavering.
Preclinical services for biologics development and manufacturing
Because the design of a program for the development and manufacture of biologics (CDER and CBER) is as unique as the therapeutic under development, you need a strong partner who understands the need for experienced, sure-handed risk management. Complete management of your biologics program includes planning, implementation, troubleshooting and the ability to move projects forward – always with an eye to time/cost containment. AIBioTech can:
- Provide analytical services to optimize the pharmacological effects of lead biologics such as therapeutic peptides, therapeutic antibodies, vaccines and gene therapies
- Develop and run GLP-level custom assaysfor measuring the performance of biologic products in preclinical studies
- Produce GLP-grade biologicsfor use in preclinical studies
- Develop and run validated analytical methods for assessing biologic potency, stability and biosafety in support of biomanufacturing