Pharmaceutical Processing World Archives - Page 2 of 64

Bristol Myers Squibb plans $400M expansion in Ireland

A rendering of the new Cruiserath campus in Dublin, Ireland. [Image courtesy of Bristol Myers Squibb]

Bristol Myers Squibb announced that it invested $400 million to build a sterile drug product (SDP) facility in Dublin, Ireland.

This Cruiserath facility will support the manufacturing and supply of existing medicines and serve as a launch excellence facility for pipeline assets. It marks the first European SDP facility for biologics manufacturing at Bristol Myers Squibb. It remains in the design phase, according to a news release.

Bristol Myers Squibb plans to begin construction in March 2024. With planning approval granted, it expects to complete construction in 2026.

The company anticipates a further 350 positions created in Ireland as a result of the investment. That brings the total for the company in Ireland to 1,000 at that campus. The new investment and the roles it creates significantly exp…

AbbVie president and COO to move into corner office

Robert Michael is slated to become AbbVie’s CEO in July 2024. [Image courtesy of AbbVie]

AbbVie (NYSE: ABBV) recently announced that its board of directors has decided to promote the company’s president and COO Robert A. Michael into the corner office.

Michael will succeed Richard A. Gonzalez, who is retiring as CEO on July 1. Gonzalez will stay as executive chair of AbbVie’s board.

“On behalf of AbbVie’s board, I am extremely excited that Rob has agreed to serve as AbbVie’s next CEO,” Gonzalez said in a Feb. 20 news release.

“As a key member of the executive leadership team, he has had a tremendous impact on AbbVie. From establishing our financial planning organization, to the development of our diversified business strategy, to successfully navigating the end of exclusivity for Humira in the U.S., Rob has been integral to AbbVie’s impact since…

Amgen opens AI-enabled Ohio biomanufacturing facility

CEO Bob Bradway rallies the manufacturing team at Amgen Ohio with a chant of “OH-IO.”

Earlier this year, NVIDIA and Amgen revealed plans to analyze one of the world’s largest human datasets using AI models trained on an NVIDIA DGX SuperPOD in Iceland. Now, Amgen is signaling its continued commitment to cutting-edge tech with a ribbon cutting for an advanced biomanufacturing facility in New Albany, Ohio.

Known as Amgen Ohio, the facility is designed to uphold the company’s reputation for quality and reliability. It will play a significant role in producing innovative biomedicines to address serious diseases, employing approximately 400 people across various roles.

The new facility “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,’” said Bob Bradway, chairman and chief executive officer at Amgen.

Amge…

Personalized medicine: advanced technology is saving lives

The concept of a “batch size one” in pharmaceutical manufacturing is closer than ever. There are companies advancing cell therapies in which body cells are used to heal or support the individual patient. These cells are manipulated or edited to change certain biological characteristics before being transferred to the patient. Personalized medicine is truly about the individual and a manufacturer’s ability to create a batch size one. These personalized treatments currently are being used on patients to provide therapies that will combat countless maladies including various types of cancer and Alzheimer’s disease.

Learn how the pharmaceutical industry can embrace personalized manufacturing without sacrificing efficiency

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MES for Flexible, Paperless Pharmaceutical Production

All companies in the pharmaceutical industry are under pressure for time, quality, compliance, and innovation. These pressures create imperatives to be both paperless and flexible to protect profitability. The stresses and imperatives apply to small-molecule pharmaceuticals, active ingredients (API), contract drug manufacturers (CDMOs), large-molecule biotechnology, and gene and cell therapy makers.

Fortunately, a manufacturing execution system (MES) proven in these pharmaceutical segments can support many aspects of these imperatives. By choosing MES wisely, such a system can support success now and into the future.

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Pave the way to high productivity with continuous manufacturing for pharma

Continuous manufacturing in the pharmaceutical industry is increasing as more manufacturers realize the benefits of the technology. But no two manufacturers are the same, which is why support from the Siemens Smart Manufacturing Solution for Pharmaceuticals helps advance the strategies of your operations.

Learn how a pharmaceutical product that previously took 1-2 months in production can now be finished after two days

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Takeda wins approval for eosinophilic esophagitis drug Eohilia

Takeda announced this week that it received FDA approval for its Eohilia (budesonide oral suspension) therapy.

This makes Eohilia the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). Takeda plans to offer it in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

Eohilia, a corticosteroid, is indicated for 12 weeks of treatment in patients 11 years and older with EoE. Developed specifically for EoE, the novel formulation of budesonide confers thixotropic properties, according to a news release. This allows for more free flow when shaken, returning to a more viscous state when swallowed.

Takeda picked up approval on the back of efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies.

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal…

Catalent cuts 300 jobs ahead of acquisition by Novo Holdings

Catalent said this week that it reduced its headcount by approximately 300 employees as part of a restructuring effort.

The company confirmed the workforce reduction in its 10-Q quarterly report, filed on Feb. 14. This also coincides with preparations for an acquisition as Novo Holdings agreed to buy the leading pharmaceutical CDMO for $16.5 billion earlier this month.

In connection with the headcount slash, Catalent incurred cumulative employee-related charges totaling approximately $12 million. Those are primarily associated with cash severance programs through Dec. 31, 2023.

The company says that it adopted plans to reduce costs, consolidate facilities and optimize infrastructure during the fiscal year ended June 30, 2023. During the three months ended Dec. 31, 2023, it extended those plans to reduce costs and headcount in its Biologics and Pharma and Consumer Health segments.

In October 2023, the company committed to closing operations at a Sa…

AbbVie is expanding its Singapore biologics plant

AbbVie (NYSE: ABBV) recently announced that it will spend $223 million to expand its Singapore biologics manufacturing facility.

Construction will commence immediately, with the facilities coming online in 2026. The added facilities will create 100 new jobs at the plant, boosting total employment to more than 500 positions in manufacturing, quality assurance, supply chain, engineering and administration roles, according to AbbVie.

AbbVie said the investment strengthens its global manufacturing network and supports its growing pipeline in treatment areas such as immunology and oncology. The Singapore expansion will add 24,000 liters of biologics drug-substance capacity to AbbVie’s global network, supporting current projects and emerging immunology and oncology compounds within AbbVie’s pipeline.

The company has invested $740 million in acquiring, modernizing and expanding its Singapore facility over the past 10 years.

“This expans…

Eicos Sciences’ FDA-approved Aurlumyn promises to drastically reduce frostbite amputations

[Adobe Stock]

Imagine scaling a mountain only to later lose digits or an entire hand to the unforgiving ravages of frostbite. For climbers, explorers, adventurous backcountry skiers, and even those caught in unexpected winter storms, severe cold exposure carries a devastating risk — amputation. Today, thanks to a potentially landmark FDA approval, the prospect of losing one’s extremities to frostbite becomes slightly less chilling.

Novel indication for iloprost

Eicos Sciences’s Aurlumyn, containing the active ingredient iloprost, offers a novel approach to treating severe frostbite. Iloprost, a synthetic version of a naturally occurring substance known as prostacyclin, targets two key problems. First, it addresses cold-induced blood vessel construction by widening them to restore essential blood flow to the affected tissues. Second, it prevents blood clots from forming, which can further block circulation…

AstraZeneca invests $300 million to establish new cell therapy manufacturing facility in Maryland

AstraZeneca facility in Maryland

Maryland Governor Wes Moore announced that AstraZeneca would invest $300 million to construct a new manufacturing facility in Rockville, a city with roughly 70,000 inhabitants that is about 17 miles from Washington, D.C. The facility will focus on cell therapies for cancer treatment. The 84,000 square-foot facility, slated for completion in 2026, will enable global clinical trials and commercial supply of AstraZeneca’s CAR-T cancer therapies. AstraZeneca estimates the plant to create 150 new high-skilled jobs.

Incentives played a role in new plant

To support AstraZeneca’s new manufacturing facility in Rockville, Maryland, the state and county are providing financial incentives, including a $500,000 conditional loan from the Maryland Department of Commerce’s Advantage Maryland program and a $100,000 conditional grant from Montgomery County’s Economic Developm…

Sanofi offers a year of salary to employees facing cancer, critical illnesses

French pharma giant Sanofi launched a new global program aimed at providing financial, social and emotional assistance to employees diagnosed with cancer or other critical illnesses.

Dubbed “Cancer & Work: Acting Together,” the program guarantees continued salary and benefits for up to one year for affected staff regardless of role or location. It also incorporates flexible work options to help employees balance treatment with their responsibilities.

“The last thing you want to be thinking about when diagnosed with cancer is work,” said Natalie Bickford, Sanofi’s Chief People Officer, in a statement. “I am delighted that Sanofi has gone further, guaranteeing job security and salary continuation for at least a year after diagnosis.”

Program offers more than financial support

In addition to the financial safeguards, the program provides access to trained volunteer employees who have dealt with cancer themselves and can offer advice and support. Psychol…