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www.biopharminternational.com Emerging Therapies eBook September 2023 BioPharm International ® 17 Cell and Gene Therapies demonstrated the superior precision of ddPCR technol- ogy over qPCR for vector copy number assessment. Lentiviral CGTs: looking forward The widespread adoption of ddPCR technolog y in CGT development and manufacturing has revolution- ized the field. A powerful and versatile tool, ddPCR technology can offer accurate quantification of len- tiviral titer and vector copy number to improve the safety and efficacy of these therapeutics profoundly. From the early stages of research and development to post-approval manufacturing, scientists can rely on the sensitivity of ddPCR assays as they navigate the challenges of CGT production. As the field con- tinues to expand and new therapeutics enter clinical trials, ddPCR technology will be an essential tool for researchers to advance these therapeutics toward regulatory approval, ultimately promoting continued advancements throughout personalized medicine. References 1. Poletti, V.; Mavilio, F. Designing Lentiviral Vectors for Gene Therapy of Genetic Diseases. Viruses 2021,13 (8),1526. DOI:10.3390/v13081526 2. Bulcha, J. T.; Wang, Y.; Ma, H.; Tai, P. W. L.; Gao, G. Viral Vector Platforms within the Gene Therapy Landscape. Sig- nal Transduction Targeted Ther. 2021, 6 (1), 53. DOI:10.1038/ s41392-021-00487-6 3. Zhao, Y.; Traylen, C.; Rigsby, P.; et al. Report on a Collabo- rative Study for the Proposed WHO 1st International Reference Panel (19/158) for the Quantitation of Lentiviral Vector Inte- gration Copy Numbers (Oct. 25, 2019). 4. Cui, R.; Bhat, V.; Zeng, Y.; et al. Development of Droplet Digital Polymerase Chain Reaction (ddPCR) Assay for a Measurement of Infectious Titers of Lenti- viral Vectors in a High Throughput Format. Mol. Ther. 2020, 28 (4), 433–433. 5. Wang, Y.; Bergelson, S.; Feschenko, M. Determination of Lentiviral Infectious Titer by a Novel Droplet Digital PCR Method. Hum. Gene Ther: Methods. 2018, 29 (2), 96–103. DOI:10.1089/hgtb.2017.198 6. Lu, A.; Liu, H.; Shi, R., et al. Application of Droplet Digital PCR for the Detection of Vector Copy Number in Clinical CAR/TCR T cell Products. J. Transl. Med. 2020, 18 (1), 191. DOI:10.1186/s12967-020-02358-0 7. Corre, G.; Seye, A.; Frin, S., et al. Lentiviral Standards to Determine the Sensitivity of Assays that Quantify Lentiviral Vector Copy Numbers and Genomic Inser- tion Sites in Cells. Gene Ther. 2022, 29 (9), 536–543. DOI:10.1038/s41434-022-00315-8 ■ Improving Aseptic Processing and Manufacturing Needs In this episode of Drug Digest, industry experts discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices. Aseptic processing is important to almost every step of the manufacturing process for bio/pharmaceuticals, including formulation, filling, and inspection (1). According to recent research, this market is expected to be valued at $83 million and to increase approximately 6.7% in the next 10 years (2). With more growth comes more challenges, and these industry practices need to be refined for the best execution with each bio/pharmaceutical created. References 1. Ascendia Pharma. Aseptic Pharmaceutical Manufacturing: How It Works. ascendiapharma.com, Nov. 17, 2021. 2. Future Market Insights. Aseptic Processing Market. Market Report, April 2023. For more episodes, visit PharmTech.com! Dan Strange, Chief Technology Officer, Cellular Origins. Richard Denk, Senior Consultant of Aseptic Processing & Containment, SKAN AG.