Manufacturing Overview: Upcoming Houston-based biomanufacturing facility; Cellular and genetic treatment centre opens in the UK

A joint venture between Vitrian, a bioproduction services company, and Howard Hughes Corporation will bring production services to the Houston suburb of Woodlands, Texas.

According to a press release, the domain has several corporations nearby, adding Millipore Sigma and KBI Biopharma. The joint venture aims to satisfy the wishes of local companies by offering a production facility in Woodlands for the use of local biotechnologies and CDMOs as well.

According to Vitrian co-founder and CEO Scott Nudelman, the company has in the past partnered with Cellipont Bioservices on its new headquarters and production facility in the Woodlands area, leading to deeper local engagement. revealed at this time.

“The dynamic environment and base of apparatuses created and maintained by Howard Hughes provide a unique position to attract and retain life sciences corporations and their workforce,” Nudelman said in the statement.

The National Health Service’s Division of Blood and Transplantation (NHSBT) opened the new facility, called the Centre for Clinical Biotechnology, located outdoors in the city of Bristol, UK. The new centre was created thanks to a £10 million ($12. 1 million) grant from the UK government.

New facility designed to manufacture clinical grade for R

“The CBC will help the UK expand its gene and mobile treatment industry into an expanding overseas market. We will not design the treatments, but we will manufacture them at the right scale and at the right clinical level. Gene and cell therapy is an expanding domain sector for the health sector and is a component of our direction as an organisation,” Lilian Hook, NHSBT’s director of mobile, apheresis and gene therapies, said in a statement.

New Jersey-based CDMO radiopharmaceutical Evergreen Theragnostics has closed a $15 million Series B building.

With this funding, CDMO is launching a new unit of its company, called Evergreen Discovery. This unit will focus on the progression of new radiopharmaceuticals for the treatment of cancer. The company also hired Thomas Reiner as chief scientific officer, who was in the past guilty of the discovery of curative radioligand drugs at Advanced Accelerator Applications, a Novartis company. Evergreen Discovery will also be founded at a new think tank near Princeton, New Jersey, in the third quarter of this year.

“The launch of Evergreen Discovery is the next logical step for us, and we are delighted to have hired Thomas to lead this new team. With Evergreen Discovery, we will expand new radiopharmaceuticals to address some of the most urgent and unmet clinical needs,” James Cook, president and CEO of Evergreen Theragnostics, in a statement.

Evergreen will also use the cash to prepare for the launch of the Ga-68 DOTATOC if approved. The HOM will have its capacity for publicity and personnel, as well as stock preparation.

Sai Life Sciences has established a GMP “Kilo Lab” at its facility in Manchester, UK, enabling the company to offer medicinal ingredient materials to its customers.

The new laboratory will have the capacity to produce up to 35 liters of product, with room to increase more capacity in the future, as well as area for other customer analytics.

“The new laboratory, located closer to our customers, was installed with full cGMP controls and world-class infrastructure. The facility will combine with our expertise in steering research, procedural chemistry and scale-up, to help our partners drive their medicines forward. journey of discovery and progression through reducing the time required for the first human clinical trials,” said Sai Life Sciences COO Sauri Gudlavalleti. in a report

Biotherapeutics CDMO GTP Bioways and Trial Development CRO Texcell and GMP Bank partner to provide comprehensive treatment progression facilities to clients around the world.

The partnership will see GTP Bioways deliver biomanufacturing and growth for customers, while Texcell will offer greater overseas success for the partnership with its offices and laboratories in France, as well as in China, Japan, the United States and Germany.

“Texcell and GTP Bioways share the same corporate philosophy. We are science-driven, customer-focused corporations focused on empathy, integrity and transparency to ensure the good fortune of our clients’ programs. Therefore, it is only herbal that our long announcement dating has become a deeper partnership,” Alain Sainsot, president of GTP Bioways said in a statement.

Porton Advanced Solutions Cell and Gene Therapy CDMO has entered into a strategic partnership with Bennu Biotherapeutics to advance T-cell treatments for tumors and autoimmune diseases.

Under the terms of the agreement, Proton will supply CDMO for several mobile and gene treatment pipelines; However, the monetary terms of the deal’s timeline were not disclosed.

“Through our end-to-end mobile and gene treatment CDMO, Porton Advanced aims to help Bennu Biotherapeutics expand multiple projects for mobile treatment products, drive the progression of cutting-edge medicines like TIL, and bring those drugs to market as soon as possible. possible. ” Yangzhou Wang, CEO of Proton Advanced, in a statement.

Cell One Partners and the CDMO Center for Breakthrough Medicines (CBM) have formed a strategic partnership to commercialize mobile and gene therapies.

The agreement will combine Cell One’s strategic functions and recommendation in mobile biotechnology and gene treatment with production at the Center for Breakthrough Medicines.

“A strategic partnership with Cell One Partners provides CGT developers with the virtual executives and strategic advisors of Cell One Partners and the expansive capacity of CBM, the breadth of CGT generation, R

Canadian manufacturer OmniaBio will expand and produce Catamaran Bio’s allogeneic CAR-NK mobile therapies, designed to treat fake tumors.

The agreement will see OmniaBio expand mobile treatment at its Toronto sites, allowing the manufacturer to move from progressive production to clinical-scale manufacturing. No additional important points of the agreement have been published.

“This collaboration will allow us to expand the scalable processes for GMP production of our ready-to-use CAR-NK mobile therapies,” Alvin Shih, CEO of Catamaran Bio, said in a statement.

Alcami has appointed Jamie Iudica as Director of Manufacturing.

Iudica has over 25 years of experience in the pharmaceutical world, having previously served as Manufacturing Director at Istari Oncology. He also held various production and control positions at corporations such as Pfizer, Hospira, and Xellia Pharmaceuticals.

“Jamie’s extensive experience in pharmaceutical production operations will be an integral part of expanding Alcami’s production footprint and operations,” Alcami CEO Patrick Walsh said in a statement.

Alcami announced that Chief Operating Officer Ken Domagalski will retire later this year.

Jubilant HollisterStier has appointed Chris Preti as its new president.

Preti has 25 years of experience in the R

“This is an exciting time to enroll in Jubilant HollisterStier, as the company continues to expand its capabilities to meet the developing industry’s demand for the high-quality facilities we offer,” Preti said in an email to Endpoints News.

More and more primary pharmaceutical and biotech corporations with many fans have revealed their overall executive pay figures, highlighting paychecks from Covid-19 giants, insulin manufacturers and developers of rare disease drugs.

Pfizer CEO Albert Bourla brought in $33. 01 million, Stéphane Bancel of Moderna amassed $19. 36 million, Dave Ricks of Eli Lilly covered $21. 398 million, Paul Hudson of Sanofi raised 10. 718 million euros (about $11. 38 million) and Tim Walbert of Horizon Therapeutics made $20. 1 million last year.

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The FDA will give Ipsen the ability to approve one of its candidates.

Ipsen announced that the FDA has set a PDUFA date of August 16, 2023, as additional data on the palovarotene clinical trial will be included in the new submission. This includes further analysis across the clinical trials program, adding the first phase III examination that was conducted in patients with fibrodysplasia ossificans or PFO.

Gossamer Bio is halting recruitment for an Ib/II trial of its BTK inhibitor in CNS lymphoma, it said in its annual report Friday morning.

The San Diego-based biotech said, “Based on the risk/benefit profile noted to date and a prioritization of resources for the seralutinib program,” it made the decision to avoid enrollment in the trial of the BTK inhibitor known as GB5121. Next, Gossamer plans to discuss the available data with the trial’s knowledge review committee, a panel of independent experts, to determine next steps. First, the trial was expected to enroll about 160 patients, according to a federal clinical trial knowledge base. .

In the wake of its $43 billion acquisition through Pfizer, Seagen is scaling back its mobile processing efforts.

The big biotech signed a licensing agreement with Gramobile Biotech last week, giving the smaller spouse rights to some patents, according to SEC filings. Gramobile will conduct preclinical and clinical studies on unnamed mobile treatment systems and possibly bring up to five to market.

However, the scope of Thursday’s settlement and the content of Seagen’s patents remain a mystery for now. Neither company issued a press release about the settlement and no monetary situations were disclosed in SEC filings. Representatives for Seagen and Gracell did not respond to requests for comment.

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In early 2020, BeiGene reached a small $132 million settlement, with $3 million in money and $5 million in fair investment, for a new cancer goal called DKK1.

Three years later, the drugmaker gave up the option to license the related drug, DKN-01, leaving its workers at Leap Therapeutics for a new partner.

When contacted via Endpoints News, neither BeiGene nor Leap specified the reason for the cancellation of the deal, which could have given BeiGene exclusive clinical and advertising rights to DKN-01 in certain Asian markets, as well as in Australia and New Zealand.

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The war over who owns the patented generation of lipid nanoparticles that carried covid-19 vaccines across the finish line and into the arms of millions remains a heated conflict. significant sum to settle claims of two small corporations that authorized the generation of LNP to Moderna.

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The launch of SpaceX’s Dragon spacecraft from Cape Canaveral last night had more on board than just for the International Space Station. It also contained study papers, adding some through Bristol Myers Squibb.

BMS’s task to examine the crystallization of biotherapeutics in microgravity is one of 20 onboard study assignments, according to a news release from the National Laboratory of the International Space Station. Dose of protein.

The FDA’s Antimicrobial Drug Advisory Committee voted 16-to-1 that Pfizer Paxlovid’s Covid-19 tablet outweighs dangers in adults with mild to moderate disease.

The vote followed hours of discussion on topics ranging from efficacy in others already vaccinated or inflamed to drug interactions (DDI). Pfizer filed an application to convert its EUA to complete approval in June, but the FDA extended its three-month review period to review additional data submitted, the company announced in December. The current date of PDUFA’s action for an FDA ruling is May 2023.

Before Keytruda’s patents fall in 2028, Merck is looking to expand a variety of combination treatments that can broaden the prospect of the mega-blockbuster. But one of those mixtures just found a problem and put the company in wounded mode.

MK-7684A, a set of pembrolizumab (the so-called Keytruda chemistry) and vibostolimab, Merck’s internal anti-TIGIT compound, failed in the open-label portion of a phase II study measuring it compared to chemotherapy in metastatic non-small mobile lung cancer, Big Pharma announced Thursday afternoon. The regimen did not reduce patients’ chances of progression-free survival compared to the control organization and was less effective than chemotherapy.

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