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SOCAL BIOSCIENCES
- Trusted Experts -
Services
Research and Development
SoCal Biosciences is highly specialized in Oligonucleotides. We provide strong support and innovation in oligonucleotide-related projects starting from oligonucleotide design library, production, compound screening in vitro, in vivo, and candidate selection and nomination. We have experience with both vaccines and therapeutic areas.
Method Development
SoCal Biosciences team designs and develops assays to support clients' needs. We perform method qualification and partial validations under GLP-like standards and ensure that we follow the appropriate regulations such as guidance documents and industry standards. We provide method transfers to GLP and GMP facilities and lead the execution of assays at CMOs and CROs to meet clients’ needs.
Bioanalytics
SoCal Biosciences team leaders are highly experienced. We bring over two decades of experience in oligonucleotides, large molecules, small molecules, and cell-based assays. Our team has extensive experience in the development and qualification of sensitive quantitative assays for supporting the pharmacokinetics (PK) and pharmacodynamics (PD) of vaccines and therapeutic drugs.
Sample Preparation
Our sample preparation services include but are not limited to:
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Tissue homogenate preparation for lipid, RNA, and protein analysis
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DNA/RNA/Protein extraction services on cell, plasma, tissue, or environmental samples (this can be used for microarray, sequencing, ddPCR, and qRT-PCR)
Sample Analysis
SoCal Biosciences is a fully equipped facility. We provide sample analysis support, using the method developed and qualified internally and externally. We provide resources needed for discovery, pre-clinical, and non-clinical programs to support regulatory filings. We provide non-GLP services within rigorously regulated environments to ensure GLP-like standards to maintain the integrity of high-quality data.
Method Transfer
SoCal Biosciences develops and qualifies reliable and robust assays to support clients’ needs. Our team has extensive experience in preparing method transfer documents and reports in detail as well as smoothly transferring to CROs and CMOs to ensure the method transfer process is successful. We also provide CRO and CMO oversight support for GLP and GMP.
Regulatory Document Preparation
SoCal Biosciences team has many years of experience in non-clinical bioanalytical strategies and CROs supporting PK/PD, as well as authored and prepared numerous bioanalytical and pharmacokinetic (PK) sections of regulatory submissions to enable clinical trials for vaccines and therapeutic programs. We provide services to author nonclinical documents including bioanalytical methods for non-GLP studies, bioanalytical and pharmacokinetic (PK) sections, CTD tables, and development reports.
Consultancy
SoCal Biosciences highly specializes in Oligonucleotides and assay development for Analytical and Bioanalytical needs. Our team offers a wide range of consulting services in support of programs, bringing over two decades of experience.