Resolian Inc. (formerly Alliance Pharma)

Resolian is a bioanalysis and drug metabolism laboratory headquartered in Malvern, Pennsylvania.^[S1][S3] Readers who know it as Alliance Pharma are in the right place: that was the name of the Malvern business until the group adopted the Resolian brand in 2023, after combining with Drug Development Solutions in the United Kingdom and Denali Medpharma in China.^[S1][S13] The group now describes five laboratories on four continents.^[S2] What it sells is measurement. Concentrations of a drug and its metabolites in biological matrices, the enzyme and transporter work that predicts how a compound is handled, biomarker assays, immunogenicity testing, and the chemistry that supports a manufacturing filing.^{[S4][S5][S6][S8]} No full toxicology service line was identified on the pages reviewed; that is an absence in those pages, not a finding that Resolian does not offer toxicology, and understanding that boundary is the first thing a sponsor needs from this profile.

Services relevant to US drug developers

What is and is not in scope

No toxicology, safety pharmacology, pathology, infectious disease or medical device testing service line was found on the company website.^[S4][S8] The published divisions are bioanalytics, analytical sciences and supporting sciences.^[S2] Sponsors should confirm whether Resolian will arrange any in-life work, which site will house animals, and how samples will be transferred, or the two are contracted separately from the start. One qualification is needed. A promotional tile on the bioanalytics page refers to a tile mentioning in vivo testing services, whose linked page was unavailable when reviewed, but the page it links to was not available, so nothing beyond that single line could be confirmed.^[S4] A sponsor who needs in-life work should treat that as a question for the company rather than as a described capability.

Regulated and exploratory bioanalysis

The bioanalytical division covers small molecules, peptides, biologics, antibody-drug conjugates and oligonucleotides, using liquid chromatography with tandem mass spectrometry, ligand binding assays, flow cytometry, high resolution mass spectrometry and polymerase chain reaction methods.^[S4] Named areas include large molecule mass spectrometry, immunoassay, peptide analysis, conjugate modalities including antibody-drug and peptide-drug conjugates, and clinical drug-drug interaction studies.^[S4] Both regulated and non-regulated work is offered, sponsors should specify the applicable quality system, the validation status and the documentation required for each assay, and the two should be scoped differently.

Drug metabolism and pharmacokinetics

In vitro work covers aqueous solubility, metabolic stability in microsomes, S9 fractions, hepatocytes and recombinant enzymes, plasma protein binding by several methods, reaction phenotyping across cytochrome P450, UGT and carboxylesterase enzymes, permeability in Caco-2 and MDCK systems, cytochrome P450 induction and both direct and time-dependent inhibition, and transporter substrate and inhibition assays across the major efflux and uptake transporters.^[S5] In vivo pharmacokinetic and toxicokinetic work in rodents is offered alongside it, positioned as support for discovery and for studies enabling an investigational new drug application.^[S5] Metabolite identification is listed as a separate capability.^[S5]

Biomarkers, cell and gene therapy, and CMC analysis

Biomarker work spans protein platforms including electrochemiluminescence and single-molecule immunoassay systems, chromatographic and high resolution mass spectrometry methods, and quantitative and droplet digital polymerase chain reaction for nucleic acid markers.^[S6] For cell and gene therapy programmes the company lists support across chimeric antigen receptor T cells, adeno-associated virus and lentiviral vectors, gene editing constructs, lipid nanoparticle formulations, messenger RNA and small interfering RNA, using flow cytometry, mass spectrometry, immunoassay, enzyme-linked immunospot and polymerase chain reaction methods.^[S7] Separately, the analytical sciences division in the United Kingdom performs manufacturing-facing chemistry, including nitrosamine testing, impurity and elemental impurity analysis, materials characterization, and extractables and leachables work.^[S8][S11] A sponsor placing chemistry work should note that this division sits in the United Kingdom rather than at the United States site.^[S2][S11]

Quality, compliance, and inspections (as stated by the company)

The company states that it has operated to good practice standards since 1998, covering good laboratory practice, good clinical practice, current good manufacturing practice and computer system validation, with more than thirty quality staff.^[S9] The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.^[S9] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.^[R2] Site-specific statements are more concrete than the group-level ones: the Australian laboratory cites accreditation by the national testing authority there, and both the United Kingdom and Australian sites name software compliant with the electronic records regulation.^[S10][S11] The company also states that it has completed regulatory inspections by the Food and Drug Administration, the Environmental Protection Agency, the European Medicines Agency, the United Kingdom medicines regulator and the Australian authority.^[S9] Completing an inspection is not an approval or certification of the laboratory.^[R6]

No AAALAC, USDA, OLAW or IACUC statement was found for the US operation on the pages reviewed; that is an absence in those pages, not a finding about the status of the company.^[S9] The only animal-related statement located is a United Kingdom licensing list that includes an animal vivarium licence, which is a different national framework.^[S9] Since the site describes rodent pharmacokinetic work, a sponsor whose study involves live animals should ask where those animals are housed and under whose oversight, and confirm the answer in the protocol.

Company facts