Services Advancing Your Therapeutics from Discovery to Market with Customized Assays and Comprehensive Support

Accurate viral vector copy number determination is achieved through molecular methods, with digital PCR (dPCR) being the most precise. Critical steps include sample preparation, assay development, and its qualification and/or validation. Depending on the target sequence and structure, multiple assays may be necessary for reliable quantification. Accelevir can develop new custom assays or optimize existing ones (e.g., qPCR assays for use in dPCR), evaluate their performance, and qualify or validate optimal assays on the right platform. 

Accelevir can support projects across a variety of vector and delivery platforms, including: AAV, LV, AV, SV40, exosome, EV, and LNP. 

Accurate, precise, and sensitive monitoring of therapeutic product during your clinical trials and in long-term follow-up is critical to evaluating efficacy and long-term safety risks.  Accelevir has supported dozens of clinical trials with scalable and automated dPCR assays under an externally audited quality and document control system. Our capabilities extend to include routine blood processing, cell subset isolation, and flow cytometry characterization, ensuring a single sample-to-answer laboratory partner for your study.

With over a decade of experience in digital PCR across multiple platforms, the Accelevir team can provide expert support for comparability and bridging studies. Accelevir routinely operates three of the most widely used digital PCR platforms today: Bio-Rad’s QX200 droplet digital PCR system, Bio-Rad’s QX600 droplet digital PCR system, and QIAGEN’s QIAcuity nanoplate-based digital PCR system. With access to and experience with other dPCR platforms, Accelevir can perform comparability studies between different platforms or between dPCR and qPCR methods. If you are considering switching platforms, Accelevir offers a range of bridging studies to test and optimize current assays for the new platform even before new equipment is installed in your laboratories.

Residual DNA impurities, such as host cell line DNA (hcDNA) and plasmid DNA (pDNA), are critical safety concerns for cell and gene therapy products. Accelevir offers both ready-to-order and fully customized ddPCR assays to detect, quantify, and size hcDNA and pDNA. 

Process-related impurities like host cell proteins (HCP) are also significant safety concerns. Accelevir offers ELISA-based quantification of HCP to ensure product safety and purity.

Accelevir leverages both short-read and long-read platforms for in-depth sequence interrogation. 

High-throughput sequencing identifies all nucleic acids in a sample. By selecting the appropriate pre-treatment, Accelevir can identify the origin of nucleic acids (e.g., encapsidated or non-encapsidated). This technique confirms the uniformity of the vector’s genome sequence and detects the frequency of mutations. Accelevir experts map to reference sequences to determine the amount of impurities and identify their origin. Additionally, Accelevir performs metagenomics analysis on unmapped sequences and in-depth analysis of chimeric sequences. Accelevir provides complete workflow services from sample preparation to data analysis for both short-read and long-read sequencing.

While ELISA-based quantification offers a simple and rapid system for quantifying assembled viral particles, nanoparticle flow cytometry enables deeper insights at the individual particle level. Accelevir offers both ELISA-based quantification and nanoparticle flow cytometry for deep characterization of lentiviral and exosome or EV products. 

Operating under Enhanced Biosafety Level 2 (BSL-2+) conditions. Accelevir is equipped with the state-of-the-art equipment. Our close association with Johns Hopkins University allows extended access and proximity to subject matter expertise.  

Accelevir provides comprehensive animal study support for both GMP and non-GMP studies. We specialize in a wide array of animal models, including rodent (mice, rats) and non-rodent species (rabbits, non-human primates). Our extensive expertise in various therapeutic areas ensures robust and reliable preclinical data to support your gene therapy development. 

Key aspects of our animal studies include: 

• Diverse Animal Models: Tailored models to meet specific study requirements, including transgenic and disease-specific models.
• GMP & Non-GMP Studies: Support for both regulatory-compliant GMP studies and exploratory non-GMP studies.
• Comprehensive Services: Full-service offerings from study design to execution and data analysis.
• Regulatory Compliance: Adherence to international standards and guidelines to ensure the highest quality and ethical standards in animal research.