Cellares Launches Cell Q, the World’s First Automated cGMP QC Workcell for Cell Therapies, to Resolve Manual QC Processing Bottleneck and Extend IDMO Capabilities from Manufacturing Through Quality Control

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Cellares Launches Cell Q, the World’s First Automated cGMP QC Workcell for Cell Therapies, to Resolve Manual QC Processing Bottleneck and Extend IDMO Capabilities from Manufacturing Through Quality Control

2024-04-18 19:01 Last Updated At：19:21

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr 18, 2024--

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today unveiled Cell Q™, the first automated quality control (QC) workcell for cell therapy manufacturing. Cell Q™ addresses a critical challenge: the manual, labor-intensive, low-throughput, and expensive nature of cell therapy QC. Exclusive to Cellares’ industry-first IDMO Smart Factories, Cell Q™ will offer a substantial improvement in throughput, cost, and reproducibility compared to existing manual QC methods.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240418031876/en/

As Cellares Cell Shuttles have addressed upstream bottlenecks in cell therapy manufacturing, Cell Q™ resolves the downstream QC capacity challenges. Cell Q™ is engineered to automate the vast majority of cell therapy QC assays for up to 6,000 batches per year. To accelerate analytical method transfer and shorten the time to clinical readout for new IDMO clients, Cell Q™ includes a pre-qualified set of the most common assays. Additionally, each Cell Q™ utilizes a modular platform that can be expanded with new instruments providing the flexibility needed to meet varying IDMO client needs.

Setting a new standard in the industry, Cellares is the only IDMO to offer the same unprecedented capacity for upstream cell therapy manufacturing as well as downstream QC via its South San Francisco Center of Excellence and Smart Factory in Bridgewater, NJ. Additional Smart Factories will be coming soon to the EU and Japan.

“Cell Q™ was designed to match the throughput of our Cell Shuttle™ platform. This enables the Cellares IDMO to offer a real end-to-end solution for our customers, providing 10 times higher capacity and up to 50% lower batch price,” said Fabian Gerlinghaus, CEO of Cellares. “Our proprietary platform technologies support our mission of becoming the de facto standard for cell therapy manufacturing, accelerating access for patients, and meeting the total patient demand for cell therapies globally.”

To learn more about how Cell Q™ enriches Cellares’ IDMO ecosystem and how it alleviates the QC bottleneck for cell therapies, please visit cellares.com/technology.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttles™ integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

For more information about Cellares, please visit cellares.com.

Columbia University threatens to expel student protesters occupying an administration building

2024-05-01 06:07 Last Updated At：06:11

NEW YORK (AP) — Dozens of protesters took over a building at Columbia University on Tuesday, barricading entrances and unfurling a Palestinian flag from a window in an escalation of demonstrations against the Israel-Hamas war on college campuses nationwide. The school promised they would face expulsion from the university.

The occupation at of the campus in New York — where protesters had shrugged off an earlier ultimatum to abandon a tent encampment Monday or be suspended — unfolded as other universities stepped up efforts to end the protests. Police swept through some campuses, leading to confrontations and arrests. In rarer instances, university officials and protest leaders struck agreements to restrict the disruption to campus life.

And as cease-fire negotiations appeared to gain steam, it wasn’t clear whether those talks would inspire an easing of campus protests.

Protesters on Columbia's Manhattan campus locked arms early Tuesday and carried furniture and metal barricades to Hamilton Hall, among several buildings that were occupied during a 1968 civil rights and anti-Vietnam War protest. Protest organizers posted on Instagram soon after midnight urging people to protect the encampment and join them at Hamilton Hall. A “Free Palestine” banner hung from a window.

On social media Tuesday, the protest group CU Apartheid Divest called the building Hind’s Hall, honoring a young girl who was among the relatives killed in a vehicle in Gaza under Israeli fire.

Hamilton Hall opened in 1907 and is named for Alexander Hamilton — one of the U.S. founding fathers — who attended King's College, Columbia's original name.

“Students occupying the building face expulsion,” Columbia spokesperson Ben Chang said in a statement Tuesday. He said the university had given protesters a chance to leave peacefully and finish the semester, but that those who didn't agree to the terms were being suspended — restricted from all academic and recreational spaces, allowed only to enter their residences, and, for seniors, ineligible to graduate.

“Protesters have chosen to escalate to an untenable situation — vandalizing property, breaking doors and windows, and blockading entrances — and we are following through with the consequences we outlined yesterday,” he said.

A CU Apartheid Divest spokesperson said at a news conference Tuesday afternoon that some students recently learned they had been suspended for protesting. She declined to give her name but said she is a Columbia graduate student who has been suspended and is not allowed back on campus.

She stressed that she was not a representative of the students who seized the administration building, but pledged that their commitment wouldn’t waver, despite the risk to their educations and careers.

“We are willing to take on an extremely minor amount of risk compared to what the heroic people of Gaza are dealing with every single day,” she said.

Later, the tent encampment was quiet and nearly empty. A small band of protesters chanted behind the university's locked gates as reporters and others watched from the other side.

Access to the campus was limited to students living in the residential buildings and essential employees, with one access point into and out of campus. New York Police Department Chief Jeffrey Maddrey said officers won’t enter Columbia’s campus without the college administration's request or an imminent emergency.

Among students suspended by Columbia Tuesday was Mahmoud Khalil, a lead negotiator before talks with the administration broke down over the weekend. His suspension letter — which he shared with The Associated Press — said he had refused to leave the encampment after prior warnings. Khalil said he had abided by the university’s demand to vacate the lawn by the Monday afternoon deadline.

Protesters have insisted they will remain in the hall until the university agrees to three demands: divestment, financial transparency and amnesty.

Ilana Lewkovitch, a 21-year-old self-described “leftist Zionist” student at Columbia, said it’s been hard to concentrate on school for weeks, amid calls for Zionists to die or leave campus. Lewkovitch, who identifies as Jewish, said she wished the current pro-Palestinian protests were more open to people like her who criticize Israel's war policies but believe there should be an Israeli state.

“I did an exam yesterday, a final exam yesterday, and the background noise was ‘say it loud, say it clear, we want Zionists out of here,’” the neuroscience student who studied at Columbia’s Tel Aviv campus said. “I have a final due today and I have a final exam due tomorrow and I cannot go to the library.”

The campus standoffs drew concern from the White House. National Security Council spokesperson John Kirby said President Joe Biden believes students occupying an academic building is “absolutely the wrong approach,” and “not an example of peaceful protest.” And Democratic New York Gov. Kathy Hochul said “there must be accountability” for the building takeover, "whether that’s disciplinary action from the school or from law enforcement.”

U.N. Secretary-General Antonio Guterres told reporters that "it is up to the university authorities to have the wisdom to properly manage situations like the ones we have witnessed.”

At California State Polytechnic University, Humboldt, where protesters occupied two buildings, dozens of police officers in helmets and carrying batons marched onto campus and cleared both overnight. The university said 25 were arrested and there were no injuries. The sweep was broadcast on the Facebook page of KAEF-TV, a satellite of KRCR-TV, until police detained the reporter.

President Tom Jackson Jr. said in a statement that “nobody wanted to see things come to this,” but that “serious criminal activity that crossed the line well beyond the level of a protest had put the campus at ongoing risk.”

California Senate President Pro Tempore Mike McGuire, whose district includes the campus, said damage there was estimated at more than $1 million.

Yale authorities cleared an encampment Tuesday morning after protesters heeded final warnings to leave, university officials said. No arrests were reported. Demonstrators said on social media that they were moving their gathering to a sidewalk. The encampment was set up Sunday, six days after police arrested nearly 50 people and took down dozens of tents.

Dozens of people were arrested Monday during protests at universities in Texas, Utah, Virginia and New Jersey.

On Tuesday, police cleared an encampment at the University of North Carolina at Chapel Hill and detained about 30 people. Later, protesters replaced an American flag there with a Palestinian one. Police then rehung the American flag. Interim Chancellor Lee Roberts told reporters that removing the American flag was “antithetical” to the nature of the UNC community. Some students responded by shouting he was “supporting the genocide of Palestinians.” Classes were canceled Tuesday.

At the University of Connecticut, police made arrests after protesters refused to remove tents. The downtown campus of Portland State University in Oregon, where protesters had been demonstrating mostly peacefully until a small group broke into the library late Monday, was closed.

The nationwide campus protests began in response to Israel’s offensive in Gaza after Hamas launched a deadly attack on southern Israel on Oct. 7. Militants killed about 1,200 people, most of them civilians, and took roughly 250 hostages. Vowing to stamp out Hamas, Israel has killed more than 34,000 Palestinians in the Gaza Strip, according to the local health ministry.

Israel and its supporters have branded the university protests as antisemitic, while Israel's critics say it uses those allegations to silence opposition. Although some protesters have been caught on camera making antisemitic remarks or violent threats, organizers of the protests, some of whom are Jewish, say it is a peaceful movement aimed at defending Palestinian rights and protesting the war.

In a rare case, Northwestern University said it reached an agreement with students and faculty who represent the majority of protesters on its campus near Chicago to allow peaceful demonstrations through the end of spring classes.

Mattise reported from Nashville, Tennessee. Associated Press journalists around the country contributed to this report, including Karen Matthews, Jim Vertuno, Hannah Schoenbaum, Sarah Brumfield, Stefanie Dazio, Christopher Weber, Carolyn Thompson, Dave Collins, Makiya Seminera, Philip Marcelo and Corey Williams.

This story has been corrected to show that Columbia University has not canceled its main graduation event.