Bristol-Myers Squibb ($BMY) is again beefing up its manufacturing operations in Puerto Rico, this time to increase capacity for producing cardiovascular and Type 2 diabetes drugs.The Big Pharma company will lay out $165 million to expand its Humacao plant. Bristol-Myers will start with the addition of 82,000 square feet of new manufacturing space, and then follow up by renovating 83,150 square feet of existing space. The company will add 100 new jobs once the project finishes in 2016.Despite recent layoffs and regulatory scrutiny of manufacturing on the Caribbean island, Bristol-Myers likes it for manufacturing. "Puerto Rico's highly skilled workforce has contributed significantly to our existing operation and plays an important role in our company's future growth," said Ricardo Zayas, senior vice president of pharmaceutical manufacturing, in a statement.Reports of low-quality operations have painted a poor picture of some Puerto Rican drug manufacturing in recent years. GlaxoSmithKline ($GSK), Pfizer ($PFE), and Johnson & Johnson ($JNJ), in addition to BMS, have all had problems there. In 2007, BMS and GSK shuttered Puerto Rican plants, laying off hundreds in the process. Two years ago, Bristol-Myers had a run-in with the FDA over poor manufacturing practices at its Manati plant, which it resolved last summer.The Humacao expansion marks the second significant project for Bristol-Myers on the island. In 2009, it spent $200 million to expand its Manati facility.- here's the Bristol-Myers statementRelated Articles:
Bristol-Myers plots $165M plant expansion in Puerto Rico
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Friday, 13 July 2012
Pharmaceutical Manufacturing-Plant Expansion-Pharma Company-Puerto Rican
Sunday, 8 July 2012
Fda Inspection Report-Adult Stem Cells-Banking Company-Manufacturing
An FDA inspection report for Texas stem cell banking company Celltex includes a long list of manufacturing and lab problems, but the company says it is more a problem of language than cGMPs.The 483 report says that during its April inspection at the Sugarland, TX, facility, the FDA discovered a lengthy list of issues, from failing to make sure the treatments produced there are sterile to labeling problems and whether the products contained the viable stem cells they are supposed to, reports in-Pharma Technologist. Inspectors found a bottle whose English-language label indicted it was a manufacturing reagent but it also had a Korean label that indicated it contained a cleaning or sanitizing product.Celltex, which provides adult stem cell banking and multiplication services, previously has been criticized for allegedly providing adult stem cells for illegal use in humans. In March Bioethicist Glenn McGee resigned from his post at stem cell company after just three months. McGee, founder of The American Journal of Bioethics, took flak from his peers in the bioethics community over his taking the position at Celltex while still serving as an editor for the journal.The company issued a statement last week that it has worked "closely with the FDA--both during its visit and since--to provide requested details and documentation to answer its questions," in-Pharma Tecnologist reports. "We have resolved many of the FDA observations, and we are working to address the remainder. We have an open line of communication with the FDA and expect to maintain that in our cooperative relationship." The company laid many of the problems off to the fact that the lab is run by its licensing partner RNL Bio with technicians and scientists from RNL's Seoul, Korea, headquarters, in-Pharma Technologist says.- read the in-Pharma Technologist story
- here's the the FDA inspection report
Related Article:
Bioethicist quits job at controversial stem cell outfit read more..
Corporate Integrity Agreement-Manufacturing Processes-Gsk
For the last two years leading up to last week's extensive settlement with U.S. authorities, GlaxoSmithKline ($GSK) already has been operating under an agreement that gives the Office of Inspector General in the Department of Health and Human Services broad authority over its manufacturing processes. The requirements are in addition to any company's usual obligations to the FDA and the agreement lays out a financial price tag if the U.K. company runs afoul of it.The provisions of the agreement are tied to deep problems at GSK's Cidra, Puerto Rico plant, which was closed in 2009. The problems, which included using tainted water in processes and mixing products in packaging, came to light in the whistleblower lawsuit brought by Cheryl Eckard, a former quality assurance manager with GSK. In October 2010, GSK agreed to pay the government $750 million to settle civil and criminal charges that it manufactured and sold adulterated drug products to Medicaid and other government health plans. The details of the compliance program have now been made public and became Appendix D to the Corporate Integrity Agreement GSK signed as part of its $3 billion settlement announced last week."This is the first time that the government, as part of a Corporate Integrity Agreement, has required a pharma company to establish a formal program to provide ongoing oversight, including Board oversight, of product released to the market to ensure that it is not adulterated," Lesley Ann Skillen, a partner in the law firm of Getnick & Getnick, who settled a related whistleblower case against Glaxo in 2010, says in an email.The oversight program is run through the "Global Manufacturing and Supply business unit" (GMS) and essentially applies to all of its manufacturing operations and employees globally. It is centered at GSK's plant in Zebulon, NC, because employees there "are responsible for the release and post-release management of all Covered Products" manufactured by the company.The program establishes a code of conduct, which employees are schooled in and must sign. It is overseen by a "GMS compliance officer" that can't be the CFO or the General Counsel of the company or subordinate to them. The compliance officer and the president of the GMS unit are the co-chairs of a compliance committee that meets quarterly to make sure the company is meeting all of its obligations. They report at least quarterly to the GSK board of directors. Board members then must sign agreements that are sent to the inspector general that the company is complying with all cGMP requirements or explain why not. The agreement also permits the FDA to complain to the inspector general if the agency believes GSK is not adequately responding to its directives.The Cidra plant was closed in 2009, 7 years after Eckard first complained to her superiors about a host of problems. In an interview last year with CBS 60 Minutes, Eckard said, "All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career." She said tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles.In her email, Skillen points out, "When Cheryl Eckard reported her concerns about the Cidra plant to the compliance department in 2003, they covered it up. If GSK were to do that now, it could face exclusion from Medicare and Medicaid under this CIA. That should provide a powerful incentive for GSK to do heed warnings they receive from their own employees. That's why it's an important document for GSK and an object lesson for the industry: ignore whistleblowers at your peril."The GSK agreement may have served as a blueprint for the 5-year consent decree that Ranbaxy Laboratories announced earlier this year to settle manufacturing and data reporting problems found at three o read more..
Sunday, 20 May 2012
Bristol-Myers Squibb-Rheumatoid Arthritis-Biologic Processes-Company Release-Mass High Tech
Five years in the making and a year in testing, Bristol-Myers Squibb ($BMY) has now been given the go-ahead by the FDA to begin manufacturing at a new plant in Devens, MA.The company is beginning with production of its injectable rheumatoid arthritis treatment Orencia, one of its best-selling drugs, but intends to expand the complex to accommodate a second biologic, reports Mass High Tech. The company in August received approval for a subcutaneous form of the pricey arthritis drug, which has been available since 2005 in IV form.The 400,000-square-foot, 6-building complex has 300 employees and is looking to hire another 50, Bristol-Myers spokesman Ken Dominski told Mass High Tech.Ground was broken on the project in 2007 and construction completed two years later, Dominski said. For a year, the company has been running equipment and testing the biologic processes for making Orencia. In March of last year, it began manufacturing a drug substance to demonstrate the processes to the FDA, the publication says.The entire complex has LEED silver certification, indicating that it meets certain standards for energy efficiency, while the lab and office building have met LEED gold certification levels, according to a company release.Bristol-Myers has a plant in Syracuse, NY, where it manufactures its biologics, and also uses contract manufacturers. It finishes and packages them in Puerto Rico at a facility that a couple of years ago received a warning letter from the FDA. Syracuse will continue to be used for development and early product launches for Bristol-Myers biologics, the release says."The increased manufacturing capacity from the Devens site will support market demand for Orencia and positions us well for future production of additional biologic medicines," says Lou Schmukler, president of global manufacturing and supply for Bristol-Myers Squibb. - read the Mass High Tech story
- the press releaseRelated Articles:
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NICE nixes Bristol's arthritis med for NHS use
BMS aims for new inspection of troubled plant read more..
Wednesday, 25 April 2012
Economic Development-Genetic Sequencing-Life Technologies-Drug Development-Manufacturing
The use of genetic sequencing in drug development is expanding and Life Technologies ($LIFE) is lining up its pieces to get more of that market with a manufacturing plant expansion in Scotland.The company says that Scottish economic development agencies are providing some help so that it can invest $20 million in its operations in Inchinnan. The expansion will increase production of its GIBCO cell culture products.The company said it expects the site up and running next year and actually shipping products in 2014. It will serve markets in Europe, the Middle East and Africa. There are currently 500 employees working at its facility at Inchinnan.It didn't disclose the level of incentives provided by Scotland, but Life Technologies CEO Gregory Lucier said the company is "grateful for the support."Life Technologies seems to be reminding potential customers it is in the game after all of the attention has been focused on competitor Illumina ($ILMN) and its back-and-forth battle with Roche ($RHHBY). The Swiss company last week gave up its $6.7 billion, $51-per-share bid for Illumina after its board repeatedly threw up roadblocks to the hostile takeover attempt.- here's the PBR story
- check out Life Technologies' releaseRelated Article:
Roche's bid for Illumina may be kaput read more..
Sunday, 11 March 2012
Biopharmaceutical Industry-Venture Capital Investors-Cell Culture Products-Ge Healthcare
GE Healthcare is expanding its line of tools to sell to the biopharmaceutical industry.It said Wednesday that it is acquiring Xcellerex, a Marlborough, MA-based supplier of turn-key manufacturing systems for the biopharmaceutical industry. The acquisition of Xcellerex will allow GE Healthcare to expand its offering of products and services to the biopharmaceuticals industry just as more companies are looking to manufacture recombinant proteins, antibodies and vaccines.Terms of the deal were not disclosed, but the company has raised about $55 million from such venture capital investors as Kleiner Perkins Caufield & Byers, SCG Capital and VantagePoint Venture Partners, according to its website. The company, which has about 135 employees, had 2011 revenues of about $50 million.Xcellerex says its biomanufacturing systems and production-scale bioreactors are based around single-use components and can be up and running faster and at less cost than building a traditional manufacturing facility. It says more than 20 therapeutic proteins and vaccines have been manufactured for clinical trials using its technology.Genetic Engineering & Biotechnology News points out that it's GE Healthcare's second acquisition in the category in 8 months. In August, it bought PAA Laboratories, which develops and manufactures cell culture products such as media, sera, growth supplements and reagents.- read the release
- here is GEN's storyRelated Articles:
GE jumps in to biologics, vaccine manufacturing game
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