OBiO Tech

Congratulation to CorrectSequence. It is our honor as CDMO partner to manufacture the clinical sample for this study.

🌟Process Characterization and Process Validation Manual🌟 This manual is a meticulously compiled professional guide by @OBiO Tech focusing on the field of Cell and Gene Therapy (CGT) process development and validation. This manual is designed to provide a comprehensive and systematic guide on process characterization and validation for colleagues in the CGT industry. If you would like to download the manual, please contact us via bd@obiosh.com. We will send it to you via email soon.

🌟Exciting news from JSGCT 2024!🌟  Dr. Guodong Jia, CEO of OBiO Tech has been invited to speak at the 30th Annual Meeting of the Japan Society of Gene and Cell Therapy. His presentation, "Overview of CGT in China: Marketing, Technology, and Regulatory Insights," delved into the latest developments and regulatory landscape of gene and cell therapy, emphasizing market trends and quality control standards.  #JSGCT2024 #Cell and Gene Therapy Thanks to Tosoh Bioscience, Inc.

🌟 Event Recap from OBiO Tech! 🌟 We are excited to share that our CEO, Javier Jia, was recently invited by the Belgian Embassy and @flanders.bio to attend a series of prestigious events celebrating the 20th anniversary of flanders.bio. This included the highly anticipated Knowledge for Growth business conference held at the Flanders Meeting & Convention Center in Antwerp. This unique opportunity allowed us to connect with key players in the global life sciences community, including decision-makers from biotech, pharma, medtech, and agricultural industries, as well as top-notch researchers, investors, and policymakers. The conference provided invaluable insights into the global life sciences landscape and fostered meaningful partnerships that will drive innovation in our field. As a leading company in cell and gene therapy, OBiO Tech is committed to advancing scientific excellence and fostering international collaborations. Javier Jia's participation in these events underscored our dedication to enhancing technological exchanges and business interactions between regions. We thanks to @flanders.bio for this opportunity and look forward to many more years of fruitful collaboration! #LifeSciences #Biotech #Innovation #OBiOTech #FlandersBio #KnowledgeForGrowth #GlobalCollaboration

A Robust Upstream Process for #AAV8 Production Scaled Up from 15 Liters to 1000 Liters Shixiong Dong, Hairui Yang, Han Gao, Ying Wang, Zehui Wang, Zhen He, Houliang Wei, Qingrui You, Guodong Jia Adeno-Associated Virus (AAV) has emerged as a pivotal tool in gene therapy, distinguished by its low immunogenicity, minimal toxicity, and non-pathogenic characteristics. While various methods exist for AAV production, the transient transfection of suspension HEK293 cells with three plasmids remains the predominant approach for large-scale production. Challenges arise in large-scale AAV production during HEK293 transfection exceeding a 1000-liter working volume, including (a) large-scale HEK293 suspension cell culture, (b) rapid mixing of DNA-PEIpro complexation in a large volume, and (c) rapid transfer of large volume transfection complexes into the bioreactor. Leveraging insights from prior small-scale bioreactor experiences, we optimized and developed the production process in a 2000-liter single-use bioreactor, culminating in a successful run. We present key data as follows: ·      Upstream harvest virus titer: 1.97E+11 vg/ml (ddPCR) ·      Host cell DNA residue: 3.4 ng/1E+12 vg ·      Host cell protein residue: 2 ng/ml ·      Full virus percentage: 84.2% (AUC) ·      Downstream total harvest ratio: 34% Significantly, virus yield and impurity levels closely match the 200-liter data, demonstrating  successful scale-up from a 15-liter reactor to a 2000-liter reactor. This achievement represents a groundbreaking advancement in overcoming the challenges associated with large-volume HEK293 transient transfection processes. OBiO Tech unwavering dedication ensures high-quality hashtag #CDMO services for consumers worldwide across preclinical, IND, clinical, and commercial stages, including hashtag plasmids, mRNA, AAV, LVV, Ad viral vectors, cell therapy (CAR-T, NK, Treg, iPSCs), exosomes, and cutting-edge technologies like inducible viral vector packaging, ultralow endotoxin processes, and AAVneO for tissue-specific AAV variants.  ❓Do not hesitate to send an inquiry or question here: https://lnkd.in/g8BzXQfQ  📞Phone: +1 408-422-9864 (U.S.)  📭Email: obio.us@obiosh.com #celltherapy #genetherapy #CDMO #ViralVectors #2024trends #globaldata #biotech

An Envelope-Modified Lentiviral Vector For Efficient Gene Delivery To Human Natural Killer Cells Jing Huang1, Ting Jiang1, Shuiling Yi1,Yongke Zhang2 Yingling Zheng1, Jiaxin Zhang1, Liya Ma1 1.      Shenzhen First Condor Life Science Co. Ltd., Dongguan 523000, Guangdong, China. 2.      OBiO Technology (Shanghai) Corp., Ltd. Shanghai, China. Natural Killer (#NK) cells play a crucial role in tumor immunotherapy. The cytotoxicity of NK cells depends on a delicate balance between activated and inhibitory receptors, and it is not restricted by MHC. Allogeneic NK cell-based clinical therapies have demonstrated in vivo expansion without inducing graft-versus-host disease (GvHD). While Chimeric Antigen Receptor T cells (CAR-T) have shown remarkable success in hematologic tumors, CAR-NK holds tremendous potential for treating various tumors However, gene delivery for NK cells has posed a challenge. Reports indicate that BAEV-TR and BAVE-less pseudotyped lentiviruses effectively infect NK cells. Yet, we observed that the titers of transducible lentiviral particles were exceptionally low when packaged with these two mutated envelopes. To identify the most effective method for modifying human NK cells and achieving industrialization, we optimized viral envelopes to allow for the highest levels of transduction (up to 90%) and a significant increase in viral yield (titer up to 5E+06 TU/mL before concentration). Lentiviral virus-transduced primary human NK cells did not show significant alterations compared to untransduced NK cells in aspects such as receptors and markers expression, K562 tumor-killing activity, cell proliferation, etc. Transduction of NK cells with lentiviral vectors containing the Nectin4 CAR expression cassette selectively enhances the cytotoxicity of NK cells against Nectin4-expressing tumor cells. In conclusion, the envelope-modified lentiviral vector proves to be a potent tool for NK cell-mediated cancer immunotherapy. OBiO Tech unwavering dedication ensures high-quality hashtag #CDMO services for consumers worldwide across preclinical, IND, clinical, and commercial stages, including hashtag plasmids, mRNA, AAV, LVV, Ad viral vectors, cell therapy (CAR-T, NK, Treg, iPSCs), exosomes, and cutting-edge technologies like inducible viral vector packaging, ultralow endotoxin processes, and AAVneO for tissue-specific AAV variants.  ❓Do not hesitate to send an inquiry or question here: https://lnkd.in/g8BzXQfQ  📞Phone: +1 408-422-9864 (U.S.)  📭Email: obio.us@obiosh.com #celltherapy #genetherapy #CDMO #ViralVectors #2024trends #globaldata #biotech

Automated Alkaline Lysis System For cGMP Production Baoyu Zhu1, Chenbeng Miao1,Qiang Xie1, Xiaolong Guo1,Yong Wu1,Cheng Chen1 Background：Supercoiled plasmid is a key raw material for gene therapy, cell therapy, nucleic acid vaccine and other fields. It is usually obtained by high-density fermentation of Escherichia coli. How to improve the lysis efficiency of supercoiled plasmid in large-scale plasmid extraction process to obtain gram scale high-purity supercoiled plasmid is a key technical bottleneck in the industry. Methods: In order to break through the technical bottleneck of the industry, OBiO Tech independently designed a large-scale plasmid Lysis system suitable for the platform process. It consists of four parts: front/back weighing and mixing unit, group pumps, unit mixer and program console. The speed ratio of the power group pump is accurately adjusted by the program algorithm, so that the weight ratio of the material and liquid can be quickly and accurately controlled, so that the two-phase material and liquid can be accurately mixed in the mixer to ensure uniform lysis effect. During the lysis process, the contact time of alkaline solution, acid neutralization time, stirring speed and stirring time in the process of plasmid lysis can be accurately controlled to ensure consistent production between batches; The lysis production adopts single-used consumables under the laminar flow hood to minimize the risk of contamination to the environment. By this optimized process of the platform, 50-100L fermentation broth could be processed per batch in large-scale production, and 4-6g of supercoiled plasmid stock solution could be produced in the following purification process. The yield of supercoiled plasmid from SEC pool to fermentation pool could be more than 40% after purification, and the HCD residue Could be < 0.2%, and the plasmid lysis efficiency Could be stable above 90%. Keywords: Cell and gene therapy, Plasmid lysis, Automated alkaline lysis system, Supercoiled plasmids OBiO Tech unwavering dedication ensures high-quality hashtag #CDMO services for consumers worldwide across preclinical, IND, clinical, and commercial stages, including hashtag plasmids, mRNA, AAV, LVV, Ad viral vectors, cell therapy (CAR-T, NK, Treg, iPSCs), exosomes, and cutting-edge technologies like inducible viral vector packaging, ultralow endotoxin processes, and AAVneO for tissue-specific AAV variants.  ❓Do not hesitate to send an inquiry or question here: https://lnkd.in/g8BzXQfQ  📞Phone: +1 408-422-9864 (U.S.)  📭Email: obio.us@obiosh.com #celltherapy #genetherapy #CDMO #ViralVectors #2024trends #globaldata #biotech 

Automated Alkaline Lysis System For cGMP Production Baoyu Zhu1, Chenbeng Miao1,Qiang Xie1, Xiaolong Guo1,Yong Wu1,Cheng Chen1 Background：Supercoiled plasmid is a key raw material for gene therapy, cell therapy, nucleic acid vaccine and other fields. It is usually obtained by high-density fermentation of Escherichia coli. How to improve the lysis efficiency of supercoiled plasmid in large-scale plasmid extraction process to obtain gram scale high-purity supercoiled plasmid is a key technical bottleneck in the industry. Methods: In order to break through the technical bottleneck of the industry, OBiO Tech independently designed a large-scale plasmid Lysis system suitable for the platform process. It consists of four parts: front/back weighing and mixing unit, group pumps, unit mixer and program console. The speed ratio of the power group pump is accurately adjusted by the program algorithm, so that the weight ratio of the material and liquid can be quickly and accurately controlled, so that the two-phase material and liquid can be accurately mixed in the mixer to ensure uniform lysis effect. During the lysis process, the contact time of alkaline solution, acid neutralization time, stirring speed and stirring time in the process of plasmid lysis can be accurately controlled to ensure consistent production between batches; The lysis production adopts single-used consumables under the laminar flow hood to minimize the risk of contamination to the environment. By this optimized process of the platform, 50-100L fermentation broth could be processed per batch in large-scale production, and 4-6g of supercoiled plasmid stock solution could be produced in the following purification process. The yield of supercoiled plasmid from SEC pool to fermentation pool could be more than 40% after purification, and the HCD residue Could be < 0.2%, and the plasmid lysis efficiency Could be stable above 90%. Keywords: Cell and gene therapy, Plasmid lysis, Automated alkaline lysis system, Supercoiled plasmids OBiO Tech unwavering dedication ensures high-quality hashtag #CDMO services for consumers worldwide across preclinical, IND, clinical, and commercial stages, including hashtag plasmids, mRNA, AAV, LVV, Ad viral vectors, cell therapy (CAR-T, NK, Treg, iPSCs), exosomes, and cutting-edge technologies like inducible viral vector packaging, ultralow endotoxin processes, and AAVneO for tissue-specific AAV variants.  ❓Do not hesitate to send an inquiry or question here: https://lnkd.in/g8BzXQfQ  📞Phone: +1 408-422-9864 (U.S.)  📭Email: obio.us@obiosh.com #celltherapy #genetherapy #CDMO #ViralVectors #2024trends #globaldata #biotech

Comparison Of Two Process Protocols For Allogeneic #CART Production With Reduced Cost #Chunxia.lu, #Changjun.Qiu, #Houliang.Wei. OBiO Tech CELL&GENE THERAPY 1.      Introduction Autologous CD19 CAR-T cells have demonstrated outstanding efficacy in B-cell malignancy. CAR-T therapy mainly focuses on autologous T cells at present due to the restriction of MHC. However, autologous preparation of CAR-T cells has drawbacks in terms of manufacturing time, cost, feasibility and scalability that can affect clinical outcome. In order to prepare off-the-shelf CAR-T cells, CRISPR/CAS9 technology was used to knock out TRAC and CD52 genes in donor T cells to avoid the potential GVHD and acquire resistance to anti-CD52 mAb based lymphodepletion after allogeneic T cell infusion. In this study, we report the allogeneic CAR-T cells production process using selected T cells and PBMC. 2.     Methods and results 2.1 Cell Banking, selection and stimulation T cells and PBMC were selected directly from apheresis  for cell banking. One bag of T cells was thawed and then stimulated with TransAct or Dynabeads CD3/CD28 CTS. One bag of PBMC was thawed to isolate T cells and then stimulated with Dynabeads CD3/CD28 CTS. 2.2 Transduction and Electroporation Lentiviral transduction was performed in a serum-free activation and transduction system. The positive rate of CAR+ is more than 80%. After transduction, the T cells were gene edited by electroporation of CRISPR/Cas9 RNP complex to knock out TRAC and CD52. The maximum volume of electroporation is 20 ml with 2E+09 Cells. The knockout efficiency of double genes of TRAC and CD52 is more than 80%. 2.3 Cell expansion Perfusion culture process with Wave Cell Expansion System was used to expand T cells. The perfusion volume is up to 25 L with cell density ≥1E+7cells/mL and more than 90% cell viability, which generated more than 100 fold of T cell amplification.  3.      Conclusion Allogeneic CAR-T production process was developed by knockout TRAC and CD52 genes. Using two starting cell sources from T cell bank or PBMC bank, we demonstrated higher activated T cells with more than 60% recovery rate. Alternately, a low cost method was developed to use PBMC banks, but the activated T cells could be affected by the positive selection efficiency of PBMC. OBiO Tech unwavering dedication ensures high-quality hashtag #CDMO services for consumers worldwide across preclinical, IND, clinical, and commercial stages, including hashtag #plasmids, mRNA, AAV, LVV, Ad viral vectors, cell therapy (CAR-T, NK, Treg, iPSCs), exosomes, and cutting-edge technologies like inducible viral vector packaging, ultralow endotoxin processes, and AAVneO for tissue-specific AAV variants.  ❓Do not hesitate to send an inquiry or question here: https://lnkd.in/g8BzXQfQ  📞Phone: +1 408-422-9864 (U.S.)  📭Email: obio.us@obiosh.com #celltherapy #genetherapy #CDMO #ViralVectors #2024trends  #globaldata #biotech 

💰Pricing For Rare Disease Therapies And Cures: What's Fair?⚖️ Effective Treatments And Cures Are Highly Valued By Payers The findings from research of 30 U.S. payers involved in coverage decisions for rare diseases suggests that novel therapies that effectively treat or cure rare diseases are highly valued, as evidenced by their views on the prices that are considered to be fair for archetype and actual therapies. The median price per year considered to be fair for therapies used to treat rare chronic diseases was $256K per year. The median price considered to be fair for curative therapies was $538K per one-time treatment. The change in median fair prices for both chronic and curative therapies between 2020 and 2023 was small (within +/- 4%). Changes in the attributes associated with the disease (e.g., prevalence, patient population) and the therapy (e.g., efficacy) affects price levels that respondents consider to be fair. The research reconfirms that context matters when it comes to perceptions of fairness. Generally, higher prices are considered to be fair for therapies that are more effective and approved to treat smaller patient populations or pediatric patient populations. In contrast, lower prices are considered to be fair for therapies that are used to treat severe conditions that are not life-threatening, and therapies approved to treat significantly larger patient populations. These findings were found to be similar when comparing the views of survey respondents in 2023 with previous findings reported in 2020. OBiO Tech unwavering dedication ensures high-quality #CDMO services for consumers worldwide across preclinical, IND, clinical, and commercial stages, including plasmids, mRNA, AAV, LVV, Ad viral vectors, cell therapy (CAR-T, NK, Treg, iPSCs), exosomes, and cutting-edge technologies like inducible viral vector packaging, ultralow endotoxin processes, and AAVneO for tissue-specific AAV variants.  ❓Do not hesitate to send an inquiry or question here: https://lnkd.in/g8BzXQfQ  📞Phone: +1 408-422-9864 (U.S.)  📭Email: obio.us@obiosh.com #cgt #cellandgenetherapy #genetherapy #celltherapy #cdmo #2024trends #globaldata #viralvector #biotech #equipment #development #manufacturing