--- title: "Bora Biologics 在圣地亚哥成功完成了 2000 升的工程和规模化运行，进一步巩固了其商业规模的准备" type: "News" locale: "zh-CN" url: "https://longbridge.com/zh-CN/news/281757479.md" description: "Bora Biologics 在其位于圣地亚哥的 FDA 批准设施成功完成了首次 2000 升的工程和放大生产，这次生产是在 3000 万美元扩建之后进行的。这个里程碑确认了扩建后的生产套件的运营准备情况，并验证了该设施在商业规模上的质量体系。此次生产包括对 TX05 生物仿制药工艺的放大，展示了其在许可阶段制造的能力。Bora Biologics 旨在为赞助商提供安全的国内制造解决方案，增强其在生物制药市场的地位" datetime: "2026-04-06T12:05:28.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/281757479.md) - [en](https://longbridge.com/en/news/281757479.md) - [zh-HK](https://longbridge.com/zh-HK/news/281757479.md) --- # Bora Biologics 在圣地亚哥成功完成了 2000 升的工程和规模化运行，进一步巩固了其商业规模的准备 **SAN DIEGO, CA / ACCESS Newswire / April 6, 2026 /** Bora Biologics today announced the successful completion of its first 2,000-liter engineering, scale up, and process confirmation run at its FDA-approved San Diego facility, marking a key milestone following the company's recent $30 million expansion. The engineering run confirms operational readiness of the expanded mammalian manufacturing suites and validates the facility's integrated upstream, downstream, and quality systems at commercially relevant scale. The campaign also included scale-up of the TX05 (trastuzumab biosimilar) process from 1,000 liters to 2,000 liters, demonstrating the suite's capability to support licensure-stage manufacturing at increased batch volumes and reinforcing Bora Biologics' expertise in technology transfer, process scale-up, and cross-functional execution at commercial scale. "Our clients are prioritizing partners who are already operating at scale-not preparing for it," said John Mosack, General Manager and Vice President, San Diego. "This successful 2,000-liter run demonstrates that our expanded infrastructure is fully operational and ready to support late-stage and commercial programs." The San Diego expansion was designed to support late-stage clinical supply, PPQ campaigns, and commercial manufacturing, with material and personnel flows enabling concurrent multi-product operations, appropriately scaled utilities, and built-in infrastructure redundancy. With capacity spanning 500L through 2,000L single-use bioreactors-and facility design engineered to accommodate future 5,000L configurations-the site provides sponsors with scalable capacity supported by commercial-grade quality systems. In parallel, Bora Biologics collaborates with Bora Pharmaceuticals' FDA-approved sterile manufacturing facility in Baltimore, Maryland, providing integrated U.S.-based fill-finish capabilities. Together, the San Diego drug substance platform and Baltimore drug product capabilities offer sponsors a coordinated, domestic biologics manufacturing solution from bulk production through final sterile fill. By completing engineering runs ahead of client demand, Bora Biologics enables sponsors to enter technology transfer and PPQ planning with reduced execution risk. This scale up milestone follows Bora Biologics' recent TX05 resubmission filing, further demonstrating the maturity of the San Diego mammalian manufacturing suites and the robustness of the site's quality systems at commercial scale. While TX05 is separate from Bora Biologics' CDMO portfolio, the filing underscores the facility's readiness to support licensure stage programs and operate under regulatory scrutiny. "Commercial manufacturing success depends on more than reactor volume," said Stephen Lam, Chief Executive Officer. "It requires disciplined manufacturing execution, uncompromising adherence to quality systems, infrastructure designed for sustained commercial cadence, and a site that is always inspection ready. That is the environment we have built in San Diego." Completed in January 2026, the $30 million expansion was executed in anticipation of increasing demand for U.S.-based late-stage and commercial biologics manufacturing capacity. Recent shifts in global trade policy and tariff announcements have further underscored the importance of domestic manufacturing infrastructure for biologics sponsors. As sponsors reassess reliance on overseas biologics capacity in response to evolving trade dynamics, FDA-approved U.S.-based capacity has become an increasingly strategic component of long-term manufacturing planning. With validated 2,000-liter drug substance capability in San Diego and integrated U.S. fill-finish support in Baltimore, Bora Biologics is positioned to support sponsors seeking secure, commercially ready domestic manufacturing solutions. By investing ahead of demand and validating the facility at full 2,000-liter scale, Bora Biologics positions itself to support sponsors approaching: \- Phase III \- BLA submission \- PPQ execution \- Commercial launch "We're not asking sponsors to plan around future capacity," added Marc Goemans, Chief Commercial Officer. "We've already built and validated it." **About Bora Biologics** Bora Biologics is a global CDMO offering agile, comprehensive end-to-end solutions for biopharma companies worldwide. With a proven track record of over 100 successful cGMP manufacturing batches, Bora Biologics leverages its state-of-the-art, FDA-registered facility in the U.S. and deep expertise in biologics development and manufacturing-including its own FDA-licensed and Health Canada approved product-to enhance time and cost efficiencies while ensuring effective pathways to market for its clients. Bora Biologics combines innovative early-phase development and late-stage manufacturing capabilities with the expertise and reputation of Bora Pharmaceuticals for flexible and scalable fill/finish services, including stability testing and final packaging of clinical and commercial products. Bora Biologics is a DBA of Tanvex BioPharma USA, Inc. **Website** www.borabiologics.com **LinkedIn** www.linkedin.com/company/bora-biologics/ **CDMO Inquiries** bd@borabiologics.com **Media Contact** media@borabiologics.com **SOURCE:** Bora Biologics View the original press release on ACCESS Newswire ### 相关股票 - [TBPH.US](https://longbridge.com/zh-CN/quote/TBPH.US.md) - [IXJ.US](https://longbridge.com/zh-CN/quote/IXJ.US.md) - [BBH.US](https://longbridge.com/zh-CN/quote/BBH.US.md) - [BIORQ.US](https://longbridge.com/zh-CN/quote/BIORQ.US.md) - [IBBQ.US](https://longbridge.com/zh-CN/quote/IBBQ.US.md) - [LABU.US](https://longbridge.com/zh-CN/quote/LABU.US.md) - [SBIO.US](https://longbridge.com/zh-CN/quote/SBIO.US.md) - [BIB.US](https://longbridge.com/zh-CN/quote/BIB.US.md) - [AMAM.US](https://longbridge.com/zh-CN/quote/AMAM.US.md) - [FBT.US](https://longbridge.com/zh-CN/quote/FBT.US.md) - [IHE.US](https://longbridge.com/zh-CN/quote/IHE.US.md) - [ARKG.US](https://longbridge.com/zh-CN/quote/ARKG.US.md) - [VHT.US](https://longbridge.com/zh-CN/quote/VHT.US.md) - [XBI.US](https://longbridge.com/zh-CN/quote/XBI.US.md) - [IBB.US](https://longbridge.com/zh-CN/quote/IBB.US.md) - [TOVX.US](https://longbridge.com/zh-CN/quote/TOVX.US.md) - [VRTX.US](https://longbridge.com/zh-CN/quote/VRTX.US.md) - [PBE.US](https://longbridge.com/zh-CN/quote/PBE.US.md) - [XLV.US](https://longbridge.com/zh-CN/quote/XLV.US.md) - [BMRN.US](https://longbridge.com/zh-CN/quote/BMRN.US.md) ## 相关资讯与研究 - [BioMarin ENPP1 缺乏症三期临床试验折戟，BMN 401 未达临床获益终点](https://longbridge.com/zh-CN/news/286795745.md) - [花旗看好催化剂与增长前景，覆盖 Ionis、Alnylam、BioMarin 并给予买入评级](https://longbridge.com/zh-CN/news/286956616.md) - [百时美施贵宝向 3 万名员工全面开放 Anthropic 公司 Claude](https://longbridge.com/zh-CN/news/287085684.md) - [强生重症肌无力治疗新药获国家药监局批准上市](https://longbridge.com/zh-CN/news/287196062.md) - [Scholar Rock 将出席杰富瑞全球医疗保健大会，聚焦 SMA 新药 apitegromab 关键审批](https://longbridge.com/zh-CN/news/287069556.md)