Anapharm Bioanalytics Bioequivalence Studies and Bioanalytical Services for Small and Large Molecule Development Programmes
Anapharm Bioanalytics is a full-service contract research organisation (CRO), providing support to the pharmaceutical, biopharmaceutical and generic industries globally, with a focus on full-service bioequivalence studies, as well as high-quality bioanalytical services for small and large molecule sample analysis in Phase I-II-III trials and non-clinical studies in compliance with EMA, FDA & ANVISA regulations.
Anapharm has highly trained scientists with over 30 years of experience in the industry. More than 1,500 bioequivalence studies have been performed and over 500 bioanalytical methods are available.
In addition, the firm has undergone 20 inspections from regulatory authorities: 14 studies inspected by FDA (US), 12 studies inspected by EU-GCP authorities and several inspections for GLP certification by EU authorities and ANVISA (Brasil). Such inspections grant its robust regulatory track record, ensuring delivery of consistent, reproducible and reliable data required for international registration.
Bioequivalence and bioavailability studies
Anapharm Bioanalytics acts as a one-stop-shop service provider for Bioequivalence studies in compliance with EMA regulations.
With two clinical units adding-up 128-bed capacity coupled with a bioanalytical lab with 13 LC-MS / MS and approximately 500 validated methods, we conduct between 100 and 120 bioequivalence studies every year.
Clinical sites are strategically located in non-EU member federations, which bring added benefits in terms of timelines for protocol approval and study initiation, as well as overall study costs.
The firm ensures fast clinical trial authorisation (CTA) approval with no Investigational Medicinal Product Dossier (IMPD) required.
Anapharm’s services include study design, protocol writing, CTA submission to authorities, clinical conduct and bioanalysis, as well as pharmacokinetic (PK) data and statistical analysis, final clinical study report, monitoring and support during regulatory registration by solving any queries from health agencies.
Small molecule bioanalysis
Anapharm Bioanalytics offers full method development and validation of proprietary assays as well as method transfers and cross-validation of Sponsor supplied methods.
The firm also provides a broad portfolio of non-proprietary assays that support bioequivalence, bioavailability, drug metabolism and other types of studies.
Anapharm provides quantitative sample analysis in a broad array of biological fluids and tissues (including human and animal matrices from different species), with 13 state-of-the-art LC-MS / MS and an annual throughput capacity of 250,000 samples. The company conducts pharmacokinetic (PK), pharmacodynamic (PD), as well as toxicokinetic (TK) studies for clinical and non-clinical studies.
The firm has expertise in complex bioanalyses, such as high sensitivity assays with sub-pg / ml LLOQ, chiral compounds, orally inhaled drugs and temperature-sensitive analyses and more.
Large molecule bioanalysis
Scientists at Anapharm have 15 years’ experience in large molecule bioanalysis by Ligand Binding Assays, having worked on more than 40 antibody-based development programs including mAb, Fab, Bispecific and biosimilar from pre-clinic to Phase III.
As part of our services in ligand binding assays (LBA), we provide PK studies, anti-drug antibody (ADA) for immunogenicity assessment, neutralising antibodies (Nab) assessment and biomarker testing, as well as anti-vector antibodies (AVA) assays, measurement of the gene therapy product in serum and vaccine proteins.
Central lab services
Anapharm Bioanalytics supplies the material required for samples collection.
These include labels for samples identification, manuals detailing blood extraction procedures, and its kits containing all the necessary elements for blood extraction such as tubes and syringes.
About Anapharm Bioanalytics
Anapharm Bioanalytics was founded in Barcelona in 2003. Its laboratory equipped with state-of-the-art instrumentation as well as its experienced staff provide full-service outsourcing solutions to preclinical studies (including non-GLP discovery projects), Phase I-III clinical trials, bioequivalence studies, bioavailability, drug metabolism and drug-drug interaction studies for worldwide registration.
The firm has a 1,500m² laboratory facility with controlled access. It has a wide range of equipment and software, including:
•There are 13 LC-MS/MS instruments:
- 3 x Sciex Qtrap 6500/UPLC
- 2 x Sciex Qtrap 5500/UPLC
- 2 x Sciex API 5000/UPLC
- 6 x Sciex API 4000/HPLC
•Enzyme-Linked Immunosorbent Assay (ELISA) with the following readouts:
•MSD – Meso QuickPlex SQ120 – ECL Tech
•Laboratory Information Management System (LIMS)
Anapharm is a customer-oriented service provider that strives to ensure consistent performance. A dedicated study director assigned to each project guarantees a transparent and fluent communication with Sponsor throughout the project.