Bioanalysis

Whether your focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides you with a full range of bioanalytical solutions to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies.

Our dedicated, skilled and experienced staff ensures that PK drug quantitation studies meet sponsor's requirements and timelines. In addition to timely, high quality data at competitive prices, QPS provides you with direct access to our technical staff, regularly scheduled updates in a format that works for you and prompt, courteous answers to your inquiries.

QPS maintains four advanced bioanalytical facilities in the USA, Netherlands, Taiwan and India, offering strategic solutions to companies with sites or trials overseas and/or wishing to complete off-shore studies in Asia and/or India. Benefit from our worldwide resources through which a portfolio of assay principles is offered to cover your entire global demand in bioanalysis for your clinical studies.

Bioanalysis Leadership Team

Luca C. Matassa
Luca C. Matassa
Vice President and Global Head of Process Development
Y
Yuan-Shek Chen
Senior Director of Bioanalytical Research
Y
Yongdong Zhu
Director of Bioanalytical GLP
J
Jamie Zhao
Director of Bioanalytical GLP
E
Eric van Ingen
Project Manager
Linda W. Whitmarsh
Linda W. Whitmarsh
SR. Manager BA Planning & Production
Joe Chen
Joe Chen
Bioanalysis Manager
Ramalingam Lakshmanan
L. Ramalingam
Deputy General Manager-Bioanalytical
Marion Kranenborg
Marion Kranenborg
Director Project Management BDM
Henk Smit
Henk Smit
Director BDM Operations
F
Fred van Heuveln
Manager Elemental Spectrometry

Method Development

QPS works with you to develop assays using the most appropriate technology platform. Before any method development work is undertaken, we sit down and discuss with you the assay requirement and its intended use, such as: 

  • Tier 1 Discovery vs. Tier 2 Discovery vs. Candidate Selection Criteria vs. Regulated Bioanalysis
  • Possible metabolites for small molecules
  • LC-MS/MS or LBA for oligonucleotide-based drugs, any modifications and the required specificity and sensitivity
  • LC-MS/MS or LBA for peptide and polypeptide drugs
  • Monoclonal or polyclonal antibodies for biologics

Our staff has considerable experience with the conventional matrices (plasma, serum, whole-blood, urine, feces), as well as various animal and human tissues.

Regulated Bioanalysis

To smooth the way for regulatory acceptance and improve chances of a successful submission, QPS complies with FDA's GLP regulations and guidance documents, as well as incorporates ex-USA GLP principles and regulations. Once the quality of the methods, data and results has been verified, a Quality Assurance Statement will be included in the final report. For regulated bioanalysis, QPS validates robust assays in accordance with:

  • The Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations as set forth in Title 21 of the U.S. Code of Federal Regulations Part 58
  • The Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice [C (97) 186/Final]
  • The Japanese Ministry of Health, Labor and Welfare (MHLW) No. 21, March 26, 1997
  • The "FDA Guidance for Industry for Bioanalytical Method Validation" May 2001
  • Workshop report, "Quantitative Bioanalytical Method Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays" February 2007
  • Workshop report, "AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples - Implications of Crystal City Recommendations" April 2009 

Small Molecules

Small Molecule Quantitation Using LC-MS/MS

LC-MS/MS is the method of choice for small molecule drug quantitation because, by definition, any molecules that can be ionized and detected can be quantitated using LC-MS/MS. Although most of the LC-MS/MS methods developed and validated by QPS are for traditional small molecule drugs, we have also developed and validated LC-MS/MS assays for large multiple-charged molecules such as polypeptides and oligonucleotides.

QPS has significant experience with various chemical structures in multiple therapeutic areas. With the increasing emphasis on "active" isomers and "active" metabolites, over 80% of our NCE studies are in the "N-in-1" format and about 15% of our new assays are chiral studies.

Equipment

QPS currently has 30 LC-MS/MS instruments between QPS Delaware and QPS Taiwan operations. QPS Delaware has 19 API 4000 triple quadrupoles mass spectrometers, as well as UPLC, LC/UV and LC/fluorescent instruments dedicated to regulated studies. Seven other LC-MS/MS instruments, including six API 4000 triple quadrupoles and linear ion trap, are dedicated to discovery, non-regulated and metabolite identification studies. QPS Taiwan has four API 4000 triple quadrupoles for bioanalysis studies.

Biologics

QPS is at the forefront of a wide range of ligand binding assays for a variety of discovery research and drug development studies. Our scientists have extensive experience in the development and validation, under GLP guidelines, of immunoassays and various technology platforms. Our in-depth technical expertise enables us to offer our clients project-based and cost-effective immunoassay services, including:

  • Assay development with ELISA, colorimetric, fluorescence, chemiluminescence and MSD electrochemiluminescence (ECL)detections
  • Assay validation under GLP regulations for PK and Immunogenicity assessment
  • Sample analysis of proprietary test article concentration or anti-drug antibody (ADA) in biological matrices.
  • Support preclinical and clinical biological drug development programs as well as monoclonal antibody screening and discovery
  • Workshop report, “Quantitative Bioanalytical Method Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays,” February 2007
Biologics by LC-MS/MS

QPS has been working on polypeptides and biologics using LC-MS/MS since 2000. The brute force approach is a combination of protein precipitation, SPE, LLE to extract, clean-up, and concentrate a standard LC-MS/MS methodology. The more elegant approach is immunoaffinity chromatography and LC-MS/MS. This methodology is essentially using an immunoaffinity column to trap the biologic, wash and back-flush onto a reverse-phase trapping column, wash and then back-flush onto an analytical column for LC-MS/MS. The decision on what methodology to use depends on the biologics. Both methodologies are non-trivial and highly experienced bioanalytical chemists are needed.

Oligonucleotides

The entire area of oligonucleotide-based drugs are receiving much higher business activity since the approval of Isis' Vitravene. As this is still a relatively new area, the quantitation of oligonucleotide-based drugs in any biological matrix is not as well established as small organics or proteins and vaccines.

QPS uses both chromatographic and ligand binding methods for quantitation of oligonucleotide-based drugs. For chromatographic methods, we have used the traditional LC-MS/MS, as well as LC/UV assays to examine plasma and tissues exposure. We are also using LC-ToF-MS for quantitation of double stranded (ds) oligonucleotides. This high resolution (LC-HRMS) methodology can simultaneously determine both the sense and the anti-sense strands using a “N-in-1” methodology where the “N”s are the exact mass of the individual isotopic peaks of the different charge envelopes. We have quantitated up to 20,000 Daltons ds oligonucleotides with LLOQ at 5 ng/mL per the latest FDA Bioanalytical Method Validation guidance.

QPS scientists will work with your development team to determine specific study parameters. The choice of detection and quantitation and whether to use chromatographic or LBA is based on the primary structure, the number of monomeric units and the desired study design.

Elemental Analysis

The vast majority of today’s modern bioanalytical methods for pharmacokinetic, pharmacodynamic and immunogenicity purposes are based on LC-MS/MS and immunoanalytical approaches. However, for a small but important number of compounds, bioanalysis with these techniques is less than satisfactory. A good alternative is Inductively Coupled Plasma Mass Spectrometry (ICP-MS). In ICP-MS, inductively coupled plasma for sample ionization (ionization source) is combined with a mass spectrometer as a method for separating and detecting the ions of interest. Some of the features of this useful tool are:

  • ICP-MS detects elements instead of molecules. With the exception of a few elements (C, H, N, O and the noble gasses), all elements can be detected. A specific element serves as a tag for the drug molecule of interest, thus enabling quantitation of this drug molecule in a particular matrix. The technique is highly linear and can be used quantitatively for a broad concentration range. Sample processing is relatively easy and throughput times are short, resulting in fast turnaround times.
  • Total concentration. Typical applications of ICP-MS are pharmacokinetic, imaging, mass balance, pharmacodynamic and toxicology studies. Furthermore ICP-MS is frequently used for limit testing of elements, trace elemental analysis and formulation analysis.
  • Molecule specific concentration. ICP-MS extended with HPLC measures the element concentration of all compounds present in the matrix that contain the element of interest and which are chromatographically separated. LC-ICP-MS enables metabolite profiling, determination of biotransformation and/or degradation products.
  • ICP-MS is capable of multi-element analysis
  • ICP-MS can be combined with LC-MS/MS (parallel detection)
  • ICP-MS can be used as detector for ELISA assays
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Validated Assays

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