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Pharma Manufacturing· Andy Lundin·· 4 小时前AI 评分43

明尼苏达生物制造服务(MBS)启用新设施,产能提升四倍

Minnesota Biomanufacturing Services quadruples capacity with new facility

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明尼苏达大学生物制造服务(MBS)在圣保罗校区启用新设施,产能提升四倍,规模为原设施五倍,2026年8月完成建设。新设施面积27,000平方英尺,新增多台生物反应器,最大体积从500L提升至1,500L,并升级纯化、分析与质量控制能力。该CDMO为非GMP设施,采用对标21 CFR 211和ICH Q7的质量管理体系,项目吞吐量提升三倍。

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To better meet sponsor demands in an increasingly complex biomanufacturing landscape, contract development and manufacturing organization (CDMO) Minnesota Biomanufacturing Services (MBS) — part of the University of Minnesota — has opened a new facility that expands its scale-up and parallel processing capabilities. 

The new MBS facility on the University of Minnesota’s St. Paul campus — which specializes in advanced fermentation and processing of microbial systems to produce high-value proteins, enzymes, and specialized metabolites — is five times larger than the CDMO’s previous facility. It has also quadrupled its capacity and has added upgrades to purification, support, analytics, and quality control.

 As part of the expansion, MBS offers dedicated spaces for small-scale development and large-scale manufacturing to better support sponsors transitioning bench-scale discoveries into scalable manufacturing processes.

“Our new facility greatly expands our capacity to provide end-to-end bioprocess development, ensuring rigorous control and optimization at every stage,” says MBS Director Marcus Schicklberger, who was responsible for the completion of the capital project. The expanded site, which was more than three years in development, was finalized in August 2026. 

New capacity, capabilities

MBS, formerly the Biotechnology Resource Center, now operates out of a 27,000-square-foot facility, with its expansion representing a significant increase in dedicated space for both upstream fermentation and downstream processing.

The added space has enabled the CDMO to introduce more bioreactors into its operations to meet growing demand from customers, including academic researchers, Fortune 500 companies, and biotech startups, according to MBS. 

Schicklberger highlighted how the expansion has increased its capabilities on both ends of the upstream process.

 “On the development side, we acquired a 12 x 1L parallel bioreactor system for process optimization, along with six 20L vessels,” says Schicklberger. “On the production side, we added two 70L, two 150L, one 300L, two 750L tanks and a 1,500L bioreactor, a significant step up from our previous capacity and maximum volume of 500L.”

Schicklberger also noted upgrades MBS made to better support high-density fermentation harvesting.

“We upgraded to a P18 Powerfuge — a notable step up from our trusted P12 model, though both are absolute workhorses — and installed a fully sterilizable disc-stack centrifuge,” he says.

With all these updates, the CDMO now supports a wide spectrum of manufacturing needs — including fed-batch and continuous fermentation — along with customized purification strategies that accommodate proteins, enzymes, live microbial products, and specialty bioindustrial molecules.

Improved throughput

The expanded facility has enabled MBS to triple its project throughput compared with its previous facility, according to Schicklberger. Helping to drive this level of productivity is the addition of dedicated spaces for small-scale development and large-scale manufacturing.

“Previously, we typically managed two concurrent workflows a week — one upstream fermentation project and one downstream purification project,” says Schicklberger.

MBS has also improved its capabilities on the recovery side with the addition of a second downstream purification suite. 

“Having parallel upstream and downstream suites means we no longer have scheduling bottlenecks — we can run multiple client campaigns simultaneously across different scales without compromising turnaround times,” he adds.

Improved flexibility

Beyond its throughput capabilities, Schicklberger also highlighted flexibility as a key advantage of the CDMO’s offerings.

Though MBS operates as a non-GMP facility, the CDMO contends it incorporates key elements of GMP design supported by a comprehensive Quality Management System aligned with 21 CFR 211 and ICH Q7 principles.  

“It’s not just larger — it’s purpose-built to incorporate key GMP-style design principles. We built in modern environmental controls, high-efficiency air filtration, formal gowning and anterooms, and strict unidirectional product flow,” says Schicklberger. “This layout minimizes contamination risk, streamlines workflows, and allows us to run multiple client projects in parallel while offering maximum operational flexibility.”

According to Schicklberger, MBS’ non-GMP status also allows it to offer sponsors a flexible, tiered quality system structured around three different levels: an R&D level, approved level, and double-sign off level.

At the R&D level, MBS can refine process parameters and adapt workflows for sponsors on the fly without formal document revisions, non-conformance filings, or deviation tracking, Schicklberger says. Meanwhile, at the approved level, batch records are drafted around a customer’s specific process, then formally reviewed and signed off by the client. Finally, at the double sign-off level, MBS executes client-approved batch documentation with dual-operator verification and sign-off at every step of production. 

“We can turn the crank relatively fast, and then, in turn, they also get all the paperwork from us — that gives them a blueprint that they can follow,” Schicklberger adds. “From there, we can help them get to a facility that follows a truly GMP-compliant design.”

An evolving industry 

The creation of the new MBS facility builds on more than a decade of significant technological innovations and major policy changes that have influenced biomanufacturing, says Schicklberger.

“When you look at the entire landscape — from overarching administrative support for biomanufacturing, key ecosystem investments like BioLabs, UEL and DMC to advances in CRISPR, cell-free synthesis, and AI for bioprospecting — the speed at which we are commercializing biological products is incredible,” he observes.

Schicklberger also stressed the significance of advanced technologies like AI and how they will influence the industry, noting that MBS is in the middle of working with another company that is developing cell-free expression — which uses AI to produce or predict products of interest.

“We are living in a really exciting time, and I think we’ve only discovered the tip of the iceberg,” he said. “It’s a great time to be part of the biomanufacturing space.”

来源:Pharma Manufacturing · pharmamanufacturing.com