Our Services
Vector | CMC | Analytics
We provide full-service AAV vector production for genetic medicine, supporting all stages from discovery to clinical trials with scalable, tailored solutions.
Our AAV vector manufacturing process is a critical first step in the development of many gene therapies. It involves designing, characterizing, and optimizing plasmids, manufacturing the vectors at the appropriate scale, and analyzing the final product.
Our research-grade AAV vectors play an essential role in a variety of preclinical applications, both in vitro and in vivo, providing the foundational tools needed to advance genetic medicines toward clinical development.
Our deep expertise and unique insights into product-specific behavior enable process development that supports robust and effective platform technologies.
With cutting-edge process technologies such as high-density suspension or adherent-based culture and novel analytics available, we can accelerate the development of your advanced therapy program from discovery through commercialization.
Our large-scale vector manufacturing process is a crucial step in the development of many gene therapies, scaling up the production of vectors that have shown promising effects in early studies.
Building on the foundation established at the research-scale stage, our large-scale manufacturing provides sufficient vector material to support more extensive preclinical investigations. This includes generating the critical data needed to meet the regulatory requirements set by agencies worldwide.
Our analytical testing services are crucial for the successful development of gene therapies. Complete characterization of both the drug product and drug substance from preclinical through clinical stages is essential for understanding biological effects and meeting the criteria set by regulatory bodies worldwide.
The evolving field of analytical testing leverages cutting-edge technologies that we deploy to ensure our products consistently meet the highest quality and safety standards.
Our AAV vector manufacturing process is a critical first step in the development of many gene therapies. It involves designing, characterizing, and optimizing plasmids, manufacturing the vectors at the appropriate scale, and analyzing the final product.
Our research-grade AAV vectors play an essential role in a variety of preclinical applications, both in vitro and in vivo, providing the foundational tools needed to advance genetic medicines toward clinical development.
Our deep expertise and unique insights into product-specific behavior enable process development that supports robust and effective platform technologies.
With cutting-edge process technologies such as high-density suspension or adherent-based culture and novel analytics available, we can accelerate the development of your advanced therapy program from discovery through commercialization.
Our large-scale vector manufacturing process is a crucial step in the development of many gene therapies, scaling up the production of vectors that have shown promising effects in early studies.
Building on the foundation established at the research-scale stage, our large-scale manufacturing provides sufficient vector material to support more extensive preclinical investigations. This includes generating the critical data needed to meet the regulatory requirements set by agencies worldwide.
Our analytical testing services are crucial for the successful development of gene therapies. Complete characterization of both the drug product and drug substance from preclinical through clinical stages is essential for understanding biological effects and meeting the criteria set by regulatory bodies worldwide.
The evolving field of analytical testing leverages cutting-edge technologies that we deploy to ensure our products consistently meet the highest quality and safety standards.
Preclinical | Translational
We support preclinical and translational studies from screening of AAVs and other advanced therapies to GLP toxicology with QA oversight. Our services include histopathology, image analysis, and safety assessments for GLP and non-GLP studies. With FDA and global submission expertise, we guide projects from proof-of-concept to approval.
Our in vivo services support the development of cell and gene therapies with expertise in animal model development, diverse administration routes, and advanced surgical and imaging techniques. We offer neurobehavioral and motor function tests, along with pharmacology, efficacy, pharmacokinetics, and IND-enabling toxicology studies.
Our in vivo operations are led by a dedicated team of board-certified veterinarians, toxicologists, and experienced technical staff committed to the highest standards of animal care and welfare. We provide comprehensive veterinary, clinical, and rodent colony management services, ensuring compliance with all federal, state, and local regulations governing biomedical research.
With a strong commitment to ethical research, we follow best practices, including the 3Rs principle—Reduce, Replace, and Refine—to uphold responsible and humane animal use in scientific advancement.
Our end-to-end pathology platform provides full-service histology, multiplex in situ hybridization (ISH), and a digital workflow, ensuring precise, high-resolution analysis to drive therapeutic success.
Our in vivo services support the development of cell and gene therapies with expertise in animal model development, diverse administration routes, and advanced surgical and imaging techniques. We offer neurobehavioral and motor function tests, along with pharmacology, efficacy, pharmacokinetics, and IND-enabling toxicology studies.
Our in vivo operations are led by a dedicated team of board-certified veterinarians, toxicologists, and experienced technical staff committed to the highest standards of animal care and welfare. We provide comprehensive veterinary, clinical, and rodent colony management services, ensuring compliance with all federal, state, and local regulations governing biomedical research.
With a strong commitment to ethical research, we follow best practices, including the 3Rs principle—Reduce, Replace, and Refine—to uphold responsible and humane animal use in scientific advancement.
Our end-to-end pathology platform provides full-service histology, multiplex in situ hybridization (ISH), and a digital workflow, ensuring precise, high-resolution analysis to drive therapeutic success.
Bioanalytics
We characterize drug products to ensure safe, effective advanced therapies. With expertise in immunogenicity, biodistribution, viral shedding, and biomarkers, we enable precise dosing and toxicity assessments from preclinical to clinical stages.
Our immunogenicity assessment services are vital for the development of safe and effective genetic medicines. Antibodies to AAVs can reduce the efficacy of gene therapies, with immune responses ranging from mild to severe.
Franklin Biolabs helps you assess immunogenicity throughout the preclinical and clinical stages to ensure the safety and effectiveness of your advanced therapies.
Our biodistribution studies utilize quantitative gene expression by qPCR across a range of matrices to provide precise data on the transfer of the advanced therapy throughout the body.
We offer validated assays for GLP programs, ensuring the highest level of accuracy and compliance for regulatory submissions and advancing the development of gene therapies.
We offer comprehensive viral shedding analysis, measuring gene profiles in blood, urine, feces, and cerebrospinal fluid (CSF) using sensitive qPCR methods. We provide validated assays for GxP-compliant sample testing, supporting regulatory submissions and advancing gene therapy programs with confidence.
Our immunogenicity assessment services are vital for the development of safe and effective genetic medicines. Antibodies to AAVs can reduce the efficacy of gene therapies, with immune responses ranging from mild to severe.
Franklin Biolabs helps you assess immunogenicity throughout the preclinical and clinical stages to ensure the safety and effectiveness of your advanced therapies.
Our biodistribution studies utilize quantitative gene expression by qPCR across a range of matrices to provide precise data on the transfer of the advanced therapy throughout the body.
We offer validated assays for GLP programs, ensuring the highest level of accuracy and compliance for regulatory submissions and advancing the development of gene therapies.
We offer comprehensive viral shedding analysis, measuring gene profiles in blood, urine, feces, and cerebrospinal fluid (CSF) using sensitive qPCR methods. We provide validated assays for GxP-compliant sample testing, supporting regulatory submissions and advancing gene therapy programs with confidence.
Featured News & Resources
Realizing Your Vision for
Advanced Therapies
From early-stage research to full-scale commercialization, our team is committed to supporting your cell and gene therapy breakthroughs. Connect with us to explore how our end-to-end solutions can help accelerate your path to success.
Contact Us