Bioanalytical Services

Altasciences has more than one hundred dedicated Bioanalytical scientists working with the latest equipment to ensure compliant and on-time regulatory submissions. We provide Bioanalytical support for all stages of drug development from preclinical studies (non-GLP and GLP) through all phases of clinical development (Phase I-IV) for both small and large molecules.

LC-MS/MS & Ligand Binding Bioanalytical Platforms

Altasciences provides Bioanalytical support for all stages of drug development from preclinical studies (non-GLP and GLP) through all phases of clinical development (Phase I-IV) for both small and large molecule programs; including Immunogenicity, Biomarker and Anti-Drug Antibody testing. With the combination of highly sensitive platforms and multiple sophisticated techniques, our extensive expertise with both generic compounds and New Molecular Entities (NME) in all biological matrices ensure highly sensitive and reliable methods.

Bioanalytical Services

Immunogenicity Services

We provide immunogenicity services by developing and applying methods commonly required in safety and efficacy studies, such as PK/PD, bridging immunogenicity, drug tolerance and neutralization assays.

Human administration of recombinant proteins or biological substances can elicit an immune response leading to the production of antibodies, which in some cases may neutralize their activity. This makes the assessment of immunogenicity an essential component of biologic safety evaluation. While bioavailability, pharmacokinetics and pharmacodynamics (PK/PD) can be effected leading to impaired efficacy, such immunogenic responses can also induce allergic reactions where in some cases severe autoimmune reactions may occur.

We provide immunogenicity services by developing and applying methods commonly required in safety and efficacy studies, such as PK/PD, bridging immunogenicity, drug tolerance and neutralization assays. We currently offer screening assays, antibody characterization and quasi-quantitative titers that describe anti-drug-antibody (ADA) immune responses. These services are available on multiple platforms including the Mesoscale Discovery (MSD) Imager (ECL), Alpha-Lisa bead-based assays with luminescence or fluorescence detection, ELISA and our newest immunogenicity platform the, SQI Diagnostics’ SQiDlite™ multiplexing system.

For more information regarding our Immunogenicity services and our newest platform please click here.

Ligand Binding

Our team provide a broad spectrum of Ligand Binding Services which are customized to specific sponsor needs. Our experienced and dedicated scientists develop and validate tailored assays to support preclinical and clinical drug development.

All aspects of our bioanalytical services are performed in compliance with GLP and current FDA/EMA guidance.

Instruments include:

  • Mesoscale Electrochemiluminescence Sector Imager for sensitive PK measurements and Immunogenicity assays.
  • BioTek Synergy H4 Multimode Plate Reader using Absorbance, Alpha, Fluorescence or Luminescence reading modes for added flexibility in designing sensitive and customized ELISA assays.
  • BioTek EL406 Microplate Washer/Dispenser for increasing sample processing throughput.
  • Luminex 200 System for performing multiplexed assays required for both preclinical and clinical studies.
  • SQI Diagnostics’ Ig_PLEX™ multiplexing technology for multiplexed biomarker determination.

Our services comprise:

  • Assay Development and Validation
  • Customizing de novo ELISA Kits in Different Formats (e.g. Competitive, Direct, and Sandwich)
  • Development of Immunogenicity Assays for Therapeutic Proteins, Monoclonal Antibodies or Polypeptides (Preclinical & Clinical)
  • Method Transfer, Optimization & Development
  • Quantitative ELISA Assay Development
  • Single or Multiplexed Biomarkers

Quantitative ELISA assays

Our scientists use innovative and cost effective approaches when customizing or developing ligand binding assays for the quantitative determination of your biologic therapeutic products. During assay development, specific attention is given to the selection of the best capture antibody or optimal antibody pair, as well as to the selection of appropriately labeled detection antibodies.

Immunogenicity Assays

To ensure immunogenicity screening assays have sufficient sensitivity to detect clinically relevant levels of Anti-Drug-Antibodies (ADAs), we compare and apply different assay formats and technology platforms such as:

  • Direct binding ELISA using a multimode plate reader.
  • Bridging ELISA and electrochemiluminescence (ECL) assays.
  • SQI Diagnostics’ Ig_PLEX™ multiplexing technology for ADA screening, isotyping and quantitation.
Method Development Strategy

The method development team consists of dedicated scientists with over 150 years of combined experience in the bioanalytical and method development fields.

Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:

  • Extremely low LLOQ
  • Low sample volume
  • Large dynamic ranges
  • Analysis of multiple metabolites
  • Analysis from various matrices (plasma, serum, CSF, blood, urine, etc.)
  • Quick method development for high throughput assays using strict criteria
  • Successful method transfer or adaptations

Our expertise enables us to overcome challenges like potential stability issues and matrix effects. We have performed extensive work on the removal of phospholipids from plasma using solid-phase and liquid-liquid extraction. The presence of the phospholipids is one of the frequent causes of matrix effect observed in bioanalysis.

Metabolites

One area of focus is to develop methods that are free of interference from metabolites. All molecules and potentially unstable metabolites such as glucuronides, sulfates and lactones are tested whenever possible using authentic reference standards. With the reference standard, multiple evaluations, including all stability evaluations, are performed to prove the absence of ex-vivo and in-vitro conversion. Also, we have developed multiple approaches to avoid interference from labile metabolites, especially for the mass spectrometer in-source and/or interface conversion of glucuronide metabolites. Techniques such as the utilization of adduct ions for analyte monitoring or use of different ionization modes are employed to avoid such interference.

Preclinical

For your preclinical studies, you need a partner that provides strong bioanalytical support.

The Bioanalytical services department at Altasciences has years of experience in innovative method development including complex molecule and metabolite testing using animal studies. Our strength is our partnership with clients. A direct relationship is established at the inception of method development, with the scientist responsible for the method, and continues throughout the process.

One of our main focuses during method development is to have methods that are free of interference from metabolites. In collaboration with our sponsors, we perform a thorough literature research and review of the investigator brochure to determine the presence of potentially unstable metabolites. If no information on metabolites is available at the preclinical stage, investigation with the samples will be done to determine the presence of suspected metabolites. Our goal with this procedure is to ensure that our reported results are not biased by the presence of a metabolite that could convert to the analyte of interest.

Once a method is ready for validation and sample analysis, a special team is dedicated to the preclinical work in order to continue the relationship established during method development. All work is conducted in compliance with GLP standards and current regulatory guidelines.

Dried Blood Spot Analysis (DBS)

We have added Dried Blood Spot (DBS) Analysis to our bioanalysis services.

DBS is gaining recognition as a superior alternative to traditional plasma collection in many research applications because it eliminates many costly, time-consuming and unpleasant aspects of sample collection while returning excellent analytical results. By using DBS, sample collection and processing is simplified, resulting in lower collection volumes, lower sample transportation costs and easier sample storage requirements. It is also safer to handle.

These are all excellent reasons to choose Dried Blood Spot analysis whenever possible for all your preclinical and clinical needs. We are prepared to use our experience with this technique to develop a robust and reliable method for your study. Research performed by the Method Development group has proven that methods using Dried Blood Spots are just as reliable as methods using traditional matrices.

For more on DBS, request the complete presentation slides from the SOT Meeting Exhibitor Session, entitled: Dried Blood Spots (DBS) in Toxicology: "Can Science Overcome the Regulatory Challenge?", presented by Dr. Fabio Garofolo.

Clinical Sample Kits & Management Support

Preparing, collecting and shipping clinical samples from trial sites to bioanalysis laboratories is a critical support service when managing clinical programs.

Altasciences provides over 20 years of clinical research experience with a sample management team supporting clinical trials worldwide. Our shipper kits and manuals are adaptable to specific study needs and are customized to facilitate accurate collection storage and shipping of different matrices such as plasma, urine, serum and whole blood.

Sample Management Support

To further support the management of study samples from international clinical sites, we offer a comprehensive Sample Handling Manual. This detailed manual includes a step-by-step sample handling description, tools to assess site capabilities, suggested sampling techniques and customized shipment instructions. As part of an integrated service, technical support is provided to each clinical site to ensure there is centralized assistance for sample handling and shipment during the clinical program. For sample handling, training for the clinical site or monitors can be provided by our bioanalytical scientists.

Take advantage of our sample management team’s expertise to simplify the collection, storage and shipment of your biological samples in global clinical trials.

Click here to download information on our Clinical Sample kits and Management Support, or please contact us at contact@altasciences.com