Westward Ho! See how Eurofins’ most western US BioPharma Product Testing site can accelerate your product development

Joe Page, Ph. D., President, Eurofins Advantar Laboratories Inc.

Eurofins Advantar Laboratories in San Diego can help you realize the golden potential of your investigational new drug. We collaborate with scientific prospectors in the pre-clinical and Phase I/II space to rapidly get your product into clinical studies. Our experienced staff has enabled many clients to strike gold by supporting their IND filings. We offer the following services to support your IP claim:

• Pre-clinical development services including molecular characterization, cell based potency assays, method development and formulation development.
• Clinical support in the form of Phase I, II and III method validations. GMP release and stability of your drug product.
• Clinical supplies - formulation and fill-finish services for both sterile and non-sterile liquid products.

Our 28,500 square foot facility with 100 employees was established in 2008 and joined the Eurofins’ network in 2016. With more than 10 PhDs on staff and state-of-the-art equipment, it is the perfect place to work your claim.

Our pre-clinical offering that supports your product development includes cell based potency assays, molecular characterization, and GLP support. Our newest offering is the development of cell-based assays. We collaborated with Eurofins BPT in Lancaster, PA, to set up a cell lab that has complementary equipment, and we hired an experienced tissue culture SME who is ready to grow, passage and harvest the cells that your drug product will transform. This tissue culture lab is equipped with biosafety cabinets, a cell counter, CO2 incubators, a microscope, and liquid nitrogen storage. Your transformed cells can be probed for the molecular events induced by your drug by ELISA, PCR, FACS (coming soon), and LCMS. Once developed, we can validate your cell based potency assay to bring it into GMP status.

Prior to initiating your toxicology and GLP studies, it is often necessary to characterize your drug substance or API prior to these studies. For protein based drug substances, our two LCMS QToFs are well equipped to peptide map your sequence with >90% coverage. We are skilled at analyzing post-translational modifications and measuring degradation events such as oxidation and deamidation. With our two LCMS triple quadrupoles, we can quantitatively measure low levels of process residuals or transformed analytes present in serum or plasma. Other characterization techniques at our site include SEC-MALS, dynamic light scattering, capillary IEF, capillary SDS, and SoloVPE. Additionally, we can provide advanced sequence services within the Eurofins network, such as Edman and Next Generation Sequencing (NGS).

We can develop a formulation that you can take into your toxicology studies. We have experience developing protein, peptide, oligo and small molecule formulations. We can design, prepare, and screen multiple formulations to help you find the most stable, clinically acceptable formulation. We can support your GLP studies by placing your lead candidate on stability for the duration of the study and performing dose verification studies.

As you progress into clinical studies, our staff has decades of experience with method validations and GMP stability studies. We will tailor your validations to your clinical stage of development. Early stage validation protocols will be streamlined with the goal of getting your clinical trial started in the fastest, most compliant manner. Later stage protocols will include all the validations elements, such as robustness, forced degradation specificity, and photo stability needed to commercialize your drug product. We can handle all aspects of your GMP stability programs from cell-based potency, sterility, and CCI within the Eurofins network, so you do not have to manage multiple sites. Our QA department has hosted many client and FDA audits, and will ensure your stability studies, from protocol to CoA, are of the highest quality.

To round out our offerings, we provide GMP compounding and fill finish service for your sterile or non-sterile drug product. We can formulate your injectable drug product, sterile filter it, and then fill it in our gloveless robotic isolator. Our VanRx Microcell filler provides the highest assurance of sterility and lowest particulate matter in the industry. We also formulate and fill non-sterile liquid oral products and topical drug products (lotions, creams and gels). We can help you select excipients, container closures, and screening studies to determine your lead candidate. Once your sterile or non-sterile drug product is filled, we provide 100% visual inspection, QC release and stability. Additionally, we can label, package, and send your drug product to its designated clinical sites.

From characterization to development to validation and clinical supplies, bring your prospecting to Eurofins Advantar Laboratories in San Diego, and we will help you find your gold.