WHAT SETS OUR BIOANALYTICAL LAB APART?
We deliver uncommon value. From discovery to post-marketing, we partner with your team to develop a custom method, transfer/optimize and validate an existing method, identify liabilities and de-risk a regulated assay, or adapt a method to increase efficiency and cost-effectiveness. The key word here is partnership – you’re more than a molecule to Worldwide. We know your early phase development comes with high stakes, and we take that seriously.
One way we demonstrate our commitment to customers is by focusing on quality. Our inspection history from 2011 to present day has consistently resulted in no observations, attesting to our focus to provide the highest quality data possible.
We know that cost will always be a factor for your organization – but not at the risk of quality. Our team provides quality service with rapid turnaround at a competitive cost. You can rely on strong scientific expertise at our Bioanalytical Laboratory in Austin, TX. Our scientists routinely analyze more than 30,000 samples per month and have demonstrated capability up to 45,000 samples per month.
With state-of-the-art instrumentation and more than 2,400 validated assays, we are at the forefront of the industry in the development of bioanalytical methodology.
Our bioanalytical work meets all regulatory standards, including:
- FDA Regulations (US Code of Federal Regulations, 21 CFR) for Good Laboratory Practice, Good Clinical Practice (GCP), Bioavailability and Bioequivalence Requirements, conduct of clinical trials, and human subject protection.
- European Clinical Trials Directive 2001/20/EC and Commission Directive 2005/28/EC.
- UK Medicines and Healthcare Products Regulatory Agency (MHRA) requirements.
Our quality assurance and quality control processes add another level of oversight. Let us demonstrate our excellence!
24/7 SPECIMEN CONTROL
We are dedicated to maintaining the integrity of your specimens by providing a 24/7 call list and accommodating emergency retrieval on nights and weekends. We ensure that every biological sample is properly collected and handled to avoid pre-analytical errors. We can provide custom labels to minimize sample discrepancies, which is especially helpful for multi-site studies.
Upon receipt of samples:
- Containers are opened to ensure all samples are frozen and intact.
- Samples are logged into our Watson Laboratory Information Management System (LIMS) database and given a unique identification number to track them through all stages of preparation and analysis.
- The temperature of each -20°C or -70°C freezer is monitored by both Tyco Integrated Security as well as a Vaisala continuous data logger.
Our site has capacity for nearly 1 million samples at any given time.
AREAS OF SCIENTIFIC EXPERTISE
- Multi-analyte assays, including metabolites
- Unstable analytes, including prodrugs
- Enantioselective assays
- Low-level (sub pg/mL) quantitation
- Immunocapture and enzymatic hydrolysis
- Microsampling, including plasma microcapillaries and dried blood spot analysis. Exploratory bioanalysis (tissues, CSF, synovial fluid) for site-of-penetration and target organ studies
BIOANALYTICAL SUPPORT SERVICES FOR YOUR PEACE OF MIND
- Method development, feasibility, and validation
- Drug discovery
- Nonclinical toxicokinetic studies
- Pharmacokinetic (PK) screening
- Pre-clinical animal and clinical sample analysis
- Dose-escalating studies
- Clinical PK/bioavailability studies
- Bioequivalency studies
- Bioavailability studies
- First-to-file studies
- Drug-drug interaction studies
- AME and protein-binding studies
- Metabolite profiling
- Pharmacogenomics screening