BASF (Ludwigshafen, Germany) introduced a new
tablet-coating system that enables individual, onsite production of soluble tablet coatings in numerous shades
from seven base colors. The company made the announcement at the annual meeting of the American Association of
Pharmaceutical Scientists in mid-November. The company also announced the availability of Soluplus, a polymeric
solubilizer, developed for hot-melt extrusion applications.
Catalent Pharma Solutions (Somerset, NJ), a provider of advanced dose form and packaging technologies, and development,
manufacturing, packaging and printing services for the pharmaceutical and biotechnology industries, has achieved
ISO 15378 certification of its printed components facility in Dublin, Ireland. The company says it is the first
secondary packaging company in Ireland to receive the certification. The ISO 15378:2006 standard, issued by the
International Organization for Standardization (ISO), incorporates the quality management requirements of ISO
9001:2000 with good manufacturing practices for the design, manufacture, and supply of primary packaging materials
for medicinal products.
The Dubai Biotechnology and Research Park (DuBiotech), a
life-sciences hub in the United Arab Emirates and a member of TECOM Investments, a subsidiary of the investment
firm Dubai Holding, signed an agreement with the Swiss Biotech Association to promote collaboration between the
two organizations. The groups will work to raise awareness among Swiss biotechnology and medical technology
companies about DuBiotech as life-sciences center.
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EMD Serono (Rockland, MA), an
affiliate of Merck KGaA (Darmstadt, Germany) reported that it received a refuse-to-file letter
from the US Food and Drug Administration on its new drug application (NDA) for EMD’s proprietary
investigational oral formulation of clardribine, a drug to treat multiple sclerosis. FDA issues a refuse-to-file
letter following a preliminary review of an NDA if it determines that the NDA is not complete. EMD Serono plans to
request a meeting with FDA to reach an understanding on what would be required for the NDA to be accepted.
Genzyme (Cambridge, MA) reported this week that it has begun shipping vials of newly produced
Cerezyme (imiglucerase for injection) manufactured at its Allston Landing, Massachusetts, plant. By the end of
this month, Genzyme will expand shipments of Cerezyme to patients worldwide who have experienced interruptions in
their treatment this year. The company expects to meet anticipated worldwide demand and allow all patients to
return to their normal infusion and dosing regimen during the first quarter of next year.
Genzyme is also
preparing to ship vials of newly produced Fabrazyme (agalsidase beta) from the Allston plant. The first two
bioreactor runs of Fabrazyme have completed their production cycles, and the output from these runs has been at
the low end. The company is currently producing Fabrazyme at a rate of approximately 70% of anticipated demand for
2010 and is working to improve productivity. Genzyme will continue to ship 30% of Fabrazyme demand during the
first quarter of 2010 to ensure continued treatment for all patients and to build inventory to begin shipping
70–100% of demand in the second quarter. The range and timing of shipments depends on restarting
fill–finish for Fabrazyme at the Allston facility and on restoring the overall productivity of Fabrazyme
manufacturing. Genzyme will have more information and will communicate further details about Fabrazyme supply in
February 2010.
Merck & Co. (Whitehouse Station, NJ) has extended its research
collaboration with the biotechnology company Idera Pharmaceuticals (Cambridge, MA) to include
agonists of toll-like receptors as vaccine adjuvants.
The drug-delivery company NexMed
(East Windsor, NJ) agreed to acquire the contract research organization Bio-Quant (San
Diego) for approximately $12.1 million. The transaction is expected to close by the end of the year.
The
special committee of independent directors of Patheon (Toronto), a provider of contract
development and manufacturing, and JLL Partners and its affiliate, JLL Patheon Holdings have entered into a
settlement agreement regarding pending litigation between the two parties. The settlement provides for the
composition of the board of directors, provisions relating to voting shares and transactions requiring independent
director approval, and a fee in connection with the settlement.
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Pfizer (China) Research
and Development Co. (Wuhan, China) and Wuhan National Bioindustry Base Construction and Management Office signed a memorandum of understanding to establish a Pfizer research and development (R&D) center in
China. The new center, located in Biolake, expands the company’s position in China, which includes an
existing Pfizer R&D center in Shanghai. Pfizer’s R&D operations in Wuhan will support clinical drug
development (Phase I–IV). Once the facility is built, Pfizer expects to staff the facility with 300
employees within three years and plans to collaborate with local research institutes and universities.
The
contract research organization PPD (Wilmington, NC) completed its $77-million acquisition of BioDuro (Beijing), a drug-discovery outsourcing company. With the acquisition, PPD now employs
1400 people in the Asia-Pacific region and 1000 people in China.
The contract manufacturer PX’Therapeutics (Grenoble, France) announced an additional manufacturing unit for producing
therapeutic proteins and monoclonal antibodies in mammalian cells. The plant, which will operate under current
good manufacturing practices (CGMP), will be operational in April 2010 and provide cell banking and preclinical
and clinical manufacturing of biotheraeputics at a scale of 100–200 L. The company also plans to update an
existing CGMP unit for bacterial and yeast systems with a 100-L bioreactor.
Ranbaxy
Laboratories (Gurgaon, Haryana, India) is voluntarily recalling one lot of Sotret (isotretinoin) capsules
USP 40 mg in the US, according to the US Food and Drug Administration’s Nov. 18 enforcement report. The cause
for the recall is out-of-specification results for methylparaben and butylated hydroxyanisole for one lot of
Sotret.
Seattle Genetics (Bothell, WA), a biotechnology company, and Agensys (Santa Monica, CA), part of the pharmaceutical company, Astellas Pharma
(Tokyo), expanded their antibody-drug conjugate (ADC) collaboration. Under the amended agreement, Agensys
will pay a $12-million fee for exclusive rights to ADC licenses against additional antigen targets. Seattle
Genetics also receives an option to codevelop another ADC at the time of submission for an investigational new
drug application. Seattle Genetics is eligible to receive up to $250 million in development milestones and $100
million is sales milestones if all of the additional ADC programs are successful.
The biotechnology
company Sinovac Biotech (Beijing) and Dalian Jin Gang Group formed a joint
venture, Sinovac (Dalian) Vaccine Technology, to research, develop, produce, and commercialize human vaccines.
Sinovac Dalian will be headquartered in Dalian, Liaoning Province, China. The facility will occupy a total area of
approximately 1 million ft2, which includes a 60,000-ft2 manufacturing and R&D facility.
The Dalian-based facility has a designed annual manufacturing capacity of 20 million doses of vero cell-cultured
vaccines and 20 million doses of live attenuated vaccines.
Soligenix (Princeton, NJ), a
biotechnology company, has formed a consortium of academic and industry partners to develop thermostable
technology for RiVax, a proprietary vaccine to protect against exposure to ricin toxin, and for other vaccines.
The company has received a $9.4-million grant from the National Institute of Allergy and Infectious Disease, which
is part of the National Institutes of Health.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
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Diaphragm valve ensures media purity
