Advanced BioScience Laboratories
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Rockville, Maryland, US
Advanced BioScience Laboratories, Inc (ABL) is a leading contract research and manufacturing organization, partnering with our clients to advance their vaccine and therapeutic development programs. Our unique combination of preclinical and clinical services provide the tools to address the scientific challenges encountered during any stage of product development. For preclinical studies, we utilize immunological, molecular, and cell-based assay platforms for candidate selection. We offer proof-of-concept in vivo studies with preclinical immunomonitoring and efficacy and potency testing. Once a clinical candidate is identified, ABL's in-house cGMP suites are designed for single-use technologies accommodating a wide range of products, including mammalian- and microbial-based protein therapeutics as well as viral vectors and vaccines.
VIRAL ANTIGENS AND PROTEINS
ABL has the capability to produce highly pure native envelope and gag HIV-1 and SIV antigens. These native proteins are purified from the conditioned media of chronically infected Human T-cell lines using immunoaffinity chromatography. They are purified by reverse phase chromatography resulting in purities greater than 95%. In addition, we offer a biologically active recombinant HIV-1 Tat protein which is produced in E. coli and purified using heparin sepharose and reverse phase chromatography. Tat is greater than 95% pure and biologically active by an HIV-1 rescue assay.
Lymphoproliferation assay
PBMC and target cell based assays
Antibody-dependent cellular cytotoxicity (ADCC) / antibody-dependent cellular phagocytosis (ADCP)
Mammalian cell lines
Microbial cell lines
Insect cell lines
Adherent and suspension-based processes
Adaptation to animal origin-free media
Up to 500 vials per bank
Cytokine detection / quantitation
Custom / Commercial / Client Methods
Qualification, verification, or partial full validation
Examine T-cell Responses by FACS
Examine B-Cell Responses by FACS
FACS analysis to determine production of IFN-gamma, TNF-alpha, IL-2, IL-4, IL-5, IL-6, IL-10, and other cytokines
Tetramer, Pentamer, Dextramer Staining Assays (TCR binding assays)
ELISPOT / Fluorospot
ABL regularly conducts upstream and downstream development work for our clients - an essential step towards efficient design of cGMP-compliant manufacturing. We draw on our scientific, manufacturing and quality expertise to design production processes that optimize product yields and minimize regulatory risk. Our technical approach incorporates the use of disposal, single use technologies to maximize flexible manufacturing capacities, reduce clean room turn around, and accelerate time to clinic.
Semi-quantitative or detection
ABL has developed high affinity murine monoclonal antibodies (Mabs) against numerous retroviral proteins, including the envelope proteins gp120 and gp160. These antibodies are purified from ascites fluid or the conditioned media from hybridoma cultures using protein A sepharose. The resulting Mabs are highly reactive and specific.
Sample processing
Assay development and fit-for-purpose analytical validation
Assay optimization and prototyping for future diagnostic tests
Sample testing for preclinical and clinical studies
ELISA / Luminex, SIMOA, Aushon, MSD
Biodistribution Studies (PCR)
PK Studies (gene therapies)
Assay optimization, characterization, verification and validation services available.
ELISA / MSD / Luminex / SIMOA / Auschon
Biodistribution Studies (PCR)
PK Studies (gene therapies)
ISO 9001:2015 Accredited
GCLP Certified
EQUAPOL (External Quality Assurance Program Oversight Laboratory) Monitored
Bioanalytical Assays Services
Pharmacology Services
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