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Provider profile

Keystone Bioanalytical.

Bioanalytical services

Keystone Bioanalytical describes GLP and non-regulated LC-MS/MS bioanalysis: method development, validation and sample analysis for PK/TK, clinical and toxicology studies, plus biomarker and oligonucleotide assays and ligand-binding capability, in matrices including plasma, whole blood, urine, CSF and tissue. It operates one laboratory in North Wales, Pennsylvania (US).

Website
keystonebioanalytical.com (opens in a new tab)
Sources reviewed
November 4, 2026 · Source pages re-checked within 4 months
First published
November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Services and capabilities

  • Biomarker assays1
  • Method development1,2
  • Method validation1
  • PK/TK bioanalysis1,3
  • Regulated study-sample analysis1,2

Platforms and methods

  • LC-MS/MS1,2,4
  • Ligand-binding assays1

Sample types

  • Cerebrospinal fluid5,6,7
  • Plasma and serum1,5
  • Tissue1
  • Urine1,5,6
  • Whole blood1,5

Development experience

Development experience

Development stage

  • Preclinical1

Modality

  • Oligonucleotides1

Locations

Locations

  • North Wales, United States · Headquarters8
  • North Wales, United States · Laboratory4

Quality and regulatory

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

Unknowns and questions to ask

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

  • Whether a validated method already exists for your molecule or a close analogue, and who owns it
  • Validation scope against ICH M10 for your assay type, and expected timeline
  • Current instrument and analyst capacity, and turnaround per sample batch
  • Sample receipt, storage conditions, chain of custody and international shipping experience
  • Most recent regulatory inspection or audit outcomes relevant to your studies
  • Data-integrity controls and the format of data delivered to your PK or biometrics vendor

How to select a bioanalytical laboratory

Evidence and sources

Evidence and sources

  1. 1Services - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2Home - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3About Us - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Facilities - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5List of Validated Assays - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  6. 6Biomarkers - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  7. 7Drugs - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  8. 8Contact Us - Keystone Bioanalytical (opens in a new tab)Keystone Bioanalytical · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

Something out of date or wrong? Request a correction. Corrections are reviewed against public sources before publication.

Contact

Contact

Contact the provider directly through its public contact page (opens in a new tab). ArgusBio does not forward inquiries to providers and does not receive referral fees.

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