Partner with our team of assay development experts, delivering robust, high-quality results through state-of-the-art technologies and proven methodologies. We rigorously review every data set to ensure accuracy, integrity, and robustness, making sure the assays perform reliably and align with your project’s needs and deadlines.
Our RNA quantification services leverage advanced techniques such as qPCR and bDNA assays to measure RNA levels with high sensitivity and accuracy. We support R&D, preclinical, and clinical studies, ensuring precise detection and quantitation of RNA across complex matrices.
Our group conducts immunological LBA and enzymatic assays to support sample analysis for large molecule drugs (e.g., biologics), peptides, anti-drug antibodies (ADA), and biomarkers (e.g., cytokines) in regulated and non-regulated drug development studies. Our primary plate-based LBA analytical platforms include enzyme-linked immunosorbent assay (ELISA), and Meso Scale Discovery (MSD) electrochemiluminescence assay, while multi-mode fluorescence is used for enzymatic assays. Further, our group is skilled at Western blot analyses, including standard methods involving electrophoresis and membrane transfer as well as in-cell Western blot methods.
We develop and optimize assays to measure drug exposure (PK) and drug responses (PD) over time. Our expertise ensures accurate quantification to support therapeutic efficacy and safety.
Our team delivers precise quantification of process impurities, ensuring product quality and safety. We develop assays tailored to detect and analyze impurities at every stage of development.
Biomarker analyses most commonly use commercially available kits. We are skilled at identification of the most sensitive and specific biomarker test kits. However, we are also experienced with making biomarker assays from “scratch” and with method transfers from clients. We conduct a fit-for-purpose (FFP) level of validation for most biomarker studies with a design based on the expected context of use for the data. Biomarkers that have been identified as key to final FDA approval of the drug proceed to full FDA compliant validation to the extent possible and regulated sample analyses. There are two basic formats for biomarker analyses, single analyte (singleplex) and multiplex assays. Meso Scale Discovery offers high quality single analyte and multiplex assay kits.
We design and execute cell-based assays to assess functional responses, potency, and efficacy. Our team’s expertise in assay development enables us to deliver reliable, reproducible data for drug screening, characterization, and validation.
The SoCal Biosciences team provides precise oligonucleotide screening and quantification services to support therapeutics. With tailored assay development, we deliver data critical for understanding efficacy, stability, and bio distribution.
Potency assays are essential quality control tools for developing cellular and gene therapies to ensure the safety, efficacy, and quality of biopharmaceutical products. Our team develops multiple RNA-related potency assays and transfers the methods to clients for evaluating the biological activity of drug candidates, supporting product development and regulatory submissions. Through rigorous assay development, we ensure accurate and reproducible potency measurements.
We can transfer in your ADA assay method or make the assay method from “scratch” in our lab. Clients typically provide the necessary positive control (PC) antibody and drug reference standard. We can subcontract PC antibody production, if the client does not have one. ADA responses to large and small molecule drugs are assessed using a multi-tiered approach as outlined by the 2019 FDA Guidance for Industry: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection. The multi-tiered approach involves detection of putative ADA (screening assay), confirmation of ADA specificity by competitive inhibition, and titration of ADA reactivity. We are also experienced with detection and quantitation of neutralizing ADA (NAb) in cell-based and enzymatic assay platforms.
Lipid analysis is crucial for understanding the behavior of RNA-LNP drugs in the body and their changes over time for vaccine and therapeutic interventions. Our expertise in lipid assay development and analysis enables precise lipid measurement across complex biological samples.
With decades of experience in drug discovery and development, SoCal Biosciences delivers end-to-end services to meet your project’s needs across different therapeutic areas.
Infectious diseases remain a significant global health challenge, driving the need for effective treatments and vaccines. Developing therapeutics in this space requires precise bioanalytical methods to measure efficacy, safety, and immune response. At SoCal Biosciences, our expertise in assay development and analysis supports critical research by delivering robust RNA, protein, lipid, and biomarker quantification to advance vaccines and antiviral therapies. We’ve been successfully supporting numerous clients from biotech companies to government agencies in this area utilizing our technical expertise and core technology.
Genetic diseases, caused by mutations in DNA, RNA, or protein expression, require innovative therapies such as gene and RNA-based treatments. Reliable bioanalysis is essential to evaluate therapeutic delivery, efficacy, and safety. Our team excels in assay development for RNA quantification, protein quantification, and biomarker analysis, providing critical data to drive advancements in genetic disease research and therapy.
Dermal conditions, including chronic skin diseases and wound healing, require targeted therapies to address inflammation, scarring, and infection. Developing effective treatments demands sensitive, well-designed assays to measure drug penetration, potency, and biomarker response. With prior experience in this area working with numerous clients on various drug discovery projects, our assay development and analysis strategies ensure comprehensive analysis, enabling researchers to advance innovative dermal therapeutics.
Metabolic diseases, such as diabetes and obesity, pose growing global health challenges, requiring therapies that address complex biochemical pathways. Bioanalytical solutions for lipid, RNA, protein, and biomarker quantification play a vital role in evaluating treatment efficacy and safety. Our tailored services provide reliable, sensitive data to advance metabolic disease research and therapeutic innovation.
Rare diseases impact small patient populations, posing unique challenges such as limited sample availability and complex disease mechanisms. Developing effective therapies in this area requires highly specialized bioanalytical approaches.
At SoCal Biosciences, we leverage advanced assay development strategies to ensure accurate, sensitive detection of therapeutic responses in rare disease. Our expertise helps researchers navigate the complexities of orphan drug programs, accelerating the development of life-changing treatments for underserved patients.
Our leadership, Dr. Patty Limphong, brings extensive bioanalytical experience in rare diseases, spanning both preclinical and clinical studies. This deep understanding enables us to provide high-quality data and insights that support the successful advancement of rare disease therapeutics.
Cardiovascular diseases remain the leading cause of mortality worldwide, driving the urgent need for innovative therapies in prevention and treatment. Bioanalysis in this field plays a crucial role in evaluating drug efficacy and monitoring disease progression. At SoCal Biosciences, our expertise in assay development ensures the delivery of precise, reliable data to support groundbreaking advancements in cardiovascular therapeutics.
Our leadership, Dr. Patty Limphong, has received specialized training in therapeutics for cardiovascular diseases from two highly recognized institutions in the field of cardiology. This foundation strengthens our commitment to providing high-quality bioanalytical solutions that contribute to the development of life-saving cardiovascular treatments.
Oncology research drives the development of life-saving cancer therapies, including targeted treatments and immunotherapies. Precise bioanalysis is critical for measuring drug efficacy, biomarker responses, and pharmacokinetics. With expertise in assay development for RNA, proteins, and biomarkers, we deliver high-quality data to support oncology research from discovery to clinical trials.
Ready to accelerate your project? Contact us today to leverage our expertise and bring your innovations to market faster! Fill out the form below or give us a call at 858-265-6311.