Dr. Tania Pereira  ChilimaUnivercells Technologies的CTO

Tania D. Pereira Chilima is the Chief Technology Officer at Univercells Technologies where she focuses driving innovation to execute our mission of making biologics globally available and affordable. She also oversees the direction of the technology portfolio and is responsible for continuously identifying new technologies that could complement our portfolio as well as the application of our systems to new modalities.

Prior to this role, she was Product Manager for the NevoLine™ platform at Univercells, and previously worked as a post-doctorate researcher for the ULTRA grant sponsored by the Bill and Melinda Gates foundation, focused on designing manufacturing strategies for ultra-low-cost vaccine manufacture.

Tania holds an engineering doctorate from the University College London in partnership with Pall Life Sciences entitled, Decisional Tools for Enabling Successful Manufacture and Commercialization of Cell Therapy Products, and is a frequent contributor to industry publications and journals.

Dr. Chilima：Univercells Technologies提供创新生物生产制造技术，旨在帮助客户在病毒产品从研发、生产制造到商业化的各个环节实现成本效益最大化。我们提供全面组合方案，支持小规模工艺开发，临床前阶段的GMP中试生产，以及通过NevoLine上游平台进行商业化生产。凭借对生产工艺强化与链化的优势，我们的技术组合方案可以在最小化占地面积和成本的情况下提高性能。我们的客户包括先进疗法、病毒载体、疫苗开发商与CDMO。例如在中国市场中，和元生物近期展示了在单纯疱疹病毒生产中使用我们的scale-X™ 产品并展示了相关技术优越性。

Univercells Technologies provides innovative biomanufacturing technologies to help customers achieve cost-effective viral production from R&D to commercial scales. Leveraging the strengths of process intensification and chaining, our technology portfolio delivers increased performance with minimized footprint and costs. We offer a comprehensive portfolio supporting small-scale process development, mid-scale GMP production for early clinical stages, to commercial-scale manufacturing via the NevoLine Upstream platform. Our customers include advanced therapies and viral vaccine developers and CDMOs. In China, OBIO Technology has recently demonstrated the advantages of using the scale-X technology for HSV production.

Dr. Chilima：对于基因治疗，这类可以改变人类生命的药物的开发者来说，从生物生产制造到商业化的过程中面临着诸多挑战，比如说，在生物制造方面的可放大性和可重复性方面存在障碍，以及在生产成本和产能方面也存在瓶颈。这些问题源于传统生产技术的应用，比如搅拌式生物反应器。它们在可放大性和产能方面，极大概率会限制开发人员只得选择scale-out策略，而不是scale-up的放大策略。而生物制品行业长期实施的流程强化和连续流制造原则可能会缓解这些挑战对基因治疗行业的影响。

The gene therapy developers are facing a number of biomanufacturing challenges which represent significant obstacles to the commercialization of these life-changing therapies, such as scalability and reproducibility hurdles, high production costs, and capacity bottlenecks. These stem from the use of inherited production technologies, such as flatware and stirred-tank bioreactors, facing scalability and capacity limitations which constrain developers to scale out rather than scale up. The principles of process intensification and continuous manufacturing, long implemented in the biologics industry, may ease the impact that these challenges have on the gene therapy industry.

Dr. Chilima：scale-X™ 生物反应器提供贴壁细胞，悬浮细胞以及病毒产物的强化生产。其核心是一种新型固定床设计，由无纺聚对苯二甲酸乙二醇酯织物层和交替间隔网组成，两者组装成螺旋缠绕结构。高密度设计为细胞培养提供了较大的表面积，结构化设计确保了快速均匀的细胞滞留，甚至确保了培养基和营养物质的可用性。这种结构化设计促进了生物反应器、批次和规模的均匀性。scale-X™ 生物反应器的可放大性依赖于流体线速度随表面积增加而恒定的原则，这确保了停留时间在任何参数下均能保持恒定。

The scale-X™ bioreactor delivers intensified production of adherent and suspension cells as well as viral products. possess at their core a novel fixed-bed design composed of non-woven polyethylene terephthalate fabric layers with alternate spacer netting, assembled as spiral-wound structure. The high-density design provides a large surface area available for cell culture, with a structured design ensuring a rapid and homogeneous cell entrapment and even media and nutrients availability. This structured designed promotes homogeneity across the bioreactor, across batches and across scales. Scalability in the scale-X bioreactor range relies on the principle of constant linear velocity of fluids with surface area increase. This ensures that the residence time remains constant at any scale.

Dr. Chilima：众所周知，尖端的技术需要尖端服务与之配套。我们的愿望是确保客户充分利用这些创新性技术，这基于scale-X™生物反应器的创新性，特别是完全集成的NevoLine上游平台。我们的服务涵盖早期的流程优化，包括中试放大及缩小反应模拟，商业化生产能力建模以及最后的设备启动及后期运行。溶瘤病毒药物开发者和制造商可以根据他们当前的发展阶段和对特定需求进行服务选择。

Cutting-edge technology requires cutting-edge services along with it. Due to the novelty of the scale-X bioreactor and especially the fully integrated NevoLine Upstream platform, we want to support our customers to ensure they are making the most of these technologies. Our services span from early process optimization, including scale-up and scale-down modeling; to commercial production capacity modeling; and finally, equipment start-up and assistance. Oncolytic virotherapy manufacturers can benefit from any of these services, depending on their current development stage and need for specific competencies.

Dr. Chilima：我们将通过不断应对当前及未来的制造工艺挑战为客户提供服务，并进一步优化整个工艺生产流程，对市场准入产生重大影响。因此，我们将继续应用强化流程原则并且整合整个价值链提供全流程的完整产品。同样，我们不会只停留在行业上游和中游，我们还将继续突破其余瓶颈。

We aim to serve our customers by continuously tackling current and upcoming manufacturing challenges, and further optimize the entire process to deliver a significant impact on market access. We are thus continuing to apply principles of process intensification and integration on the entire value chain to offer a complete offering from very small to large scale. It is also important not to stop at upstream and midstream, we need to debottleneck previous and subsequent steps.