Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

AGA Medical Holdings files patent infringement lawsuit against Gore

AGA Medical Holdings, Inc. today announced that it has filed a patent infringement lawsuit against W.L. Gore & Associates (Gore). AGA Medical is alleging that Gore is infringing AGA Medical's U.S. Patent No. 5,994,738 which covers certain transcatheter occlusion products for the treatment of structural heart defects.

25 Aug 2010

3Sbio, Isotechnika Pharma sign development and commercialization agreement for voclosporin inhibitor

Isotechnika Pharma Inc., a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, and 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases.

25 Aug 2010

CMC Biologics completes new, disposable manufacturing facility at Seattle

CMC Biologics, a Contract Manufacturing Organization with manufacturing sites in Europe and the USA, today announced the completion of a new state-of-the-art disposable manufacturing facility at its Seattle, WA site. The addition comes as part of a staged major expansion plan, which will add significant production capacity to its existing facility to accommodate a growing demand for cGMP manufacture of biopharmaceuticals.

25 Aug 2010

Kamada, Baxter enter distribution and manufacturing agreement for Glassia Alpha-1 Antitrypsin Product

Kamada, Ltd., a biopharmaceutical company engaged in development, production and marketing of specialty life-saving therapeutics and Baxter International Inc., a global, diversified healthcare company announced today that they have entered into an exclusive distribution and manufacturing agreement for Kamada's liquid, ready to use, intravenous Alpha-1 Antitrypsin Product for the treatment of hereditary Alpha-1 Antitrypsin Deficiency approved by the USFDA on July 1st, 2010 for marketing under the trade name "Glassia™".

From Baxter International Inc. 25 Aug 2010

BioScale installs ViBE analytical tool at Massachusetts-based pharmaceutical company

BioScale Inc., an innovative life science company that develops, manufactures and promotes novel analytical tools enabling advancements in protein research, today announced the first shipment and installation of the ViBE™ Protein Analysis Workstation at a major Massachusetts-based pharmaceutical company.

25 Aug 2010

Wellington Foods moves to new cGMP compliant manufacturing facility

Wellington Foods, Inc., a leading nutritional supplement manufacturer, has announced the expansion of its production operation to its new headquarters in Corona, California. Moving to the larger state-of-the-art manufacturing facility, Wellington Foods has made a significant commitment to the long-term growth of the company and to the natural products industry.

25 Aug 2010

DSM Biomedical signs new licensing agreements with global medical device manufacturers

DSM Biomedical, a global leader in biomedical materials science, and its Berkeley based operation, DSM PTG, today announced the company has entered into six multi-year licensing agreements with global medical device manufacturers in the Orthopedic, Cardiovascular, Vascular and Urology fields in this year alone.

25 Aug 2010

Hemispherx Biopharma enters agreement to settle pending securities class actions

Hemispherx Biopharma, Inc. today announced that, as result of court mediation proceedings, it has entered into a written agreement in principle with the Court-appointed lead plaintiffs to settle all of the currently pending securities class actions consolidated in the U.S. District Court for the Eastern District of Pennsylvania.

24 Aug 2010

Alnylam Pharmaceuticals to present results on RNAi therapeutics at ACS National Meeting

Alnylam Pharmaceuticals, Inc.,a leading RNAi therapeutics company, announced today that it will make a total of 16 oral presentations at the American Chemical Society (ACS) Fall 2010 240th National Meeting & Exposition being held in Boston, Mass. from August 22-26, 2010.

24 Aug 2010

3SBio and Isotechnika enter strategic agreement for voclosporin in China

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products and Isotechnika Pharma Inc., a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, today announced the signing of a development and commercialization agreement for voclosporin.

24 Aug 2010

Harvard Bioscience announces acquisition of Coulbourn Instruments

Harvard Bioscience, Inc., a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, today announced that it has acquired the business of Coulbourn Instruments through a purchase of substantially all of Coulbourn's assets.

From Harvard Bioscience 24 Aug 2010

ArtVentive Medical Group signs development agreement with Medical Murray

ArtVentive Medical Group, Inc. announced the Company has signed a manufacturing, research and development agreement with Medical Murray Inc.. Medical Murray is a leader in medical device and product development including specialty manufacturing services.

24 Aug 2010

Pfizer's Prevenar 13-valent pneumococcal conjugate vaccine receives WHO prequalification

The World Health Organization (WHO) has granted prequalification to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])for active immunization of infants and children from 6 weeks through five years of age against invasive disease, pneumonia and otitis media caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine.

24 Aug 2010

SEB opens new state-of-the-art laboratory operation, R&D facility

Cryo-Cell International, Inc., one of the largest and most established leaders in stem cell innovation today announced that S-Evans Biosciences, the Company's exclusive Célle menstrual stem cell technology license partner in China has opened a new state-of-the-art laboratory operation and research & development facility located in a Hi-Tech park designated to become an epicenter for stem cell and genomics R&D; cellular therapies and stem cell cryopreservation services.

23 Aug 2010

FDA approves Alexion's Rhode Island manufacturing facility as commercial supply source for Soliris

Alexion Pharmaceuticals, Inc. today announced that the US Food and Drug Administration (FDA) has approved Alexion's Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of commercial supply for Soliris® (eculizumab).

23 Aug 2010

Getinge's vascular graft production unit receives warning letter from FDA

Getinge's production unit in Wayne, New Jersey, US, has received a warning letter from the US FDA (Food and Drug Administration). The warning letter originates from an inspection performed by the authority on the Wayne plant during the spring of 2010. The FDA's observations and remarks relate to the manufacture of vascular grafts

23 Aug 2010

Samplify receives second series of patent for medical imaging applications

Samplify Systems, Inc., a leading provider of signal-compression technology, semiconductors, and solutions, today announced that the Chinese Government has granted the company its second series of technology patents for medical imaging applications. These new patents come on the heels of the first series of patents that were granted earlier this month for wireless base station compression.

23 Aug 2010

HHS Secretary releases review of new federal approach to medical countermeasures

U.S. Department of Health and Human Services Secretary Kathleen Sebelius today released an examination of the federal government's system to produce medications, vaccines, equipment and supplies needed for a health emergency, known as medical countermeasures. The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs reviews the process and makes recommendations for a better approach.

21 Aug 2010

HHS unveils $1.9B strategy to better prepare for biological threats

"Acknowledging that the development of medical countermeasures against bioterrorism threats and pandemic flu is lagging, [U.S.] federal authorities Thursday announced a $1.9 billion makeover of the system for identifying and manufacturing drugs and vaccines for public-health emergencies," Tribune Company/Seattle Times reports.

21 Aug 2010

HCG Platinum improves formula of hormone diet product

MARCH 2010 proved to change the diet industry forever when HCG Platinum launched their product in Anaheim, California at the Natural Products Expo West. With growing consumer concerns about credible weight loss products, Platinum perfected the HCG hormone diet by adding three amino acids to the formula, making it not only the most effective diet product on the market, but also the safest.

21 Aug 2010

Manufacturing News and Research

Further Reading

AGA Medical Holdings files patent infringement lawsuit against Gore

3Sbio, Isotechnika Pharma sign development and commercialization agreement for voclosporin inhibitor

CMC Biologics completes new, disposable manufacturing facility at Seattle

Kamada, Baxter enter distribution and manufacturing agreement for Glassia Alpha-1 Antitrypsin Product

BioScale installs ViBE analytical tool at Massachusetts-based pharmaceutical company

Wellington Foods moves to new cGMP compliant manufacturing facility

DSM Biomedical signs new licensing agreements with global medical device manufacturers

Hemispherx Biopharma enters agreement to settle pending securities class actions

Alnylam Pharmaceuticals to present results on RNAi therapeutics at ACS National Meeting

3SBio and Isotechnika enter strategic agreement for voclosporin in China

Harvard Bioscience announces acquisition of Coulbourn Instruments

ArtVentive Medical Group signs development agreement with Medical Murray

Pfizer's Prevenar 13-valent pneumococcal conjugate vaccine receives WHO prequalification

SEB opens new state-of-the-art laboratory operation, R&D facility

FDA approves Alexion's Rhode Island manufacturing facility as commercial supply source for Soliris

Getinge's vascular graft production unit receives warning letter from FDA

Samplify receives second series of patent for medical imaging applications

HHS Secretary releases review of new federal approach to medical countermeasures

HHS unveils $1.9B strategy to better prepare for biological threats

HCG Platinum improves formula of hormone diet product

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