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Advertisement:
analytica, March 23 – 26, 2010 in Munich, Germanyy
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at
 www.analytica.de/en |
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 Updated software automates quality control
MODA Technology Partners (Wayne, PA) has introduced version 3.0 of its Mobile Data Acquisition platform (MODA), which enables quality-control and environmental-monitoring systems to be automated from sampling to report generation. The software allows users to generate barcodes for samples and track where they are taken. New analytical tools allow personnel to determine which parts of a facility have systemic problems.
The product is designed to support paperless sampling and to enable compliance with standard operating procedures (SOPs). Users can configure the MODA software easily to match the steps in their SOPs. This feature helps to improve the quality of the information that results from the sampling process.
In addition, MODA can provide specialized touchscreen tablet computers that can be introduced into cleanrooms. The computers withstand chemical cleaners, and the software is easily navigated by personnel wearing cleanroom suits.
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The specialty pharmaceutical company AlphaRx (Markham, Canada) announced that its licensee, Gaia BioPharma (Hong Kong), a biopharmaceutical company, signed an agreement with a contract manufacturing organization to manufacture GAI-122 for use in Phase I and Phase II clinical trials. GAI-122 is being developed as an intravenous-administered formulation of an intracellular neuroprotectant that uses AlphaRx's proprietary nanoemulsion formulation technology. GAI-122 has the potential to treat patients with acute ischemic stroke or to prevent postoperative delirium.
The contract manufacturing organization AMRI (Albany, NY) received certification by SafeBridge Consultants (Mountain View, CA) of its high-potency research laboratories and good manufacturing practice facilities in Rensselaer, New York. The certification applies to specific AMRI laboratories and manufacturing areas designed for the research, development, and manufacture of potent compounds and certifies AMRI is competent and proficient in the safe handling of potent active pharmaceutical ingredients.
DSM Specialty Intermediates, a business unit of Royal DSM NV (Heerlen, The Netherlands) will cease operations by the end of 2010. The company’s Chemelot industrial site in Sittard-Geleen, The Netherlands, is scheduled to close during July 2010, resulting in the loss of 37 jobs. DSM Specialty Intermediates produces intermediates for the pharmaceutical, food, and automotive industries.
Advertisement:
 Vetter Development Service Chicago
Peter Soelkner
Managing Director, Vetter Pharma International GmbH
Listen to this podcast recorded live from the show floor of AAPS 2009. Clinical development is key for new drugs. In order to minimize risks and take advantage of opportunities, you need comprehensive know-how and years of experience. Vetter, as a specialist in the aseptic filling of injection systems, will provide with its new facility the manufacturing of preclinical, Phase I and Phase II clinical batches in Chicago. We invite you to find out more about Vetter Development Services USA Inc.
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NextPharma Technologies (Surrey, UK), a contract provider of pharmaceutical development, manufacturing, cold-chain, and distribution services, received approval from Austrian regulatory officials for its expanded temperature-controlled storage facilities in Stockerau, Austria.
Patheon (Research Triangle Park, NC), a contract provider of pharmaceutical development and manufacturing services, began construction of a pharmaceutical-development center at its facility in Bourgoin, France. The new facility is designed for late-phase, clinical-trial tablets and capsule products, and will be capable of handling batch sizes up to 120 kg.
Ricerca Biosciences (Concord, OH), a contract provider of pharmaceutical development and manufacturing services, announced the validation of the Watson Laboratory Information Management System for its Bioanalysis Division. The system will help Ricerca electronically track shipments and samples and handle standard to complex protocols, enabling greater productivity in the laboratory and faster turnaround times.
The chemical company Wacker Chemie (Munich, Germany), which includes Wacker Biotech, a contract manufacturer of biopharmaceuticals derived from microbial systems, and the biotechnology company MorphoSys (Planegg, Germany) expanded their cooperation agreement to include use of Wacker’s technology for the production of antigen material. The expanded agreement also covers the production of antibodies in both the early-development phase of therapeutic projects and in the production of diagnostic and research antibodies.
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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FDA issued a revised guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, which is an International Conference on Harmonization (ICH) guidance published originally in 1997. The guidance recommends international standards for nonclinical safety studies in human clinical trials and marketing authorization for pharmaceuticals. The revisions “further harmonize recommendations in a number of areas and include a new section on exploratory clinical studies,” said the document. This revised guidance discusses other nonclinical studies that should be conducted on a case-by-case basis as appropriate, including phototoxicity studies, immunotoxicity studies, juvenile-animal toxicity studies, and abuse potential studies.”
According to an Associated Press article, New York Governor David Paterson would like new, more-strict prohibitions on pharmaceutical companies when it comes to giving gifts and information to doctors. Industry disagrees with the idea, according to the article, arguing that FDA already regulates marketing practices. This isn’t the first time this topic has come up. See PharmTech's related blog posts, “Pharma Marketers May Have to Get More Creative” and “Sunshine on My (Doctor’s) Shoulder.”
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Novartis (Basel) announced that Daniel Vasella will step down next month as the company’s chief executive officer. Vasella, who will keep his position as chairman, will be replaced by Joe Jimenez, who heads Novartis’ pharmaceutical unit.
The US Food and Drug Administration named Jeffrey E. Shuren director of the Center for Devices and Radiological Health. Shuren, acting director since September 2009, has held various positions at FDA, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
American Society of Quality (ASQ) awarded fellow status to William B. Stinchcomb of Abbott Laboratories (Abbott Park, IL). Stinchcomb was recognized by ASQ for “significant contributions in sharing best practices for assuring data quality, integrity, and security; and for demonstrating lifelong learning of quality technical knowledge and sharing this knowledge through education and mentoring programs."
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The Formulation and Evaluation of Topical Berberine-Hydrochloride Products |
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| Nikunjana A. Patel, Natvar J. Patel, Rakesh P. Patel, Rakesh K. Patel |
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The authors sought to prepare a topical formulation of berberine hydrochloride for the effective and controlled management of inflammation and skin infections.
Coming Soon: PhRMA's Billy Tauzin discusses healthcare reform and innovation in the February issue.
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Survey:
7th Annual Biomanufacturing Survey: Participation Request
As part of Pharmaceutical Technology’s goal of supporting the biopharmaceutical community, we have partnered with BioPlan Associates, Inc. to collect data for the 7th Annual Report and Survey of Biopharmaceutical Manufacturing. This global benchmarking study measures today's most important trends and shifts in biomanufacturing. Please share your opinions and perspectives for this important international study. You will be ensuring that this industry is properly measuring today's issues such as capacity utilization, batch-failure rates, outsourcing, disposables usage, expression systems, hiring and training, and many others.
• Please participate to ensure the Biopharmaceutical community is properly represented in this global study
• You will also receive a free summary of the results
To participate in the survey, please click here.
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Lyophilization
Recently, the following statement was made about lyophilization:
"To remove water by freezing it, subliming the ice and then condensing the
water vapor is time consuming, wasteful in energy consumption and very
expensive in hardware. An easier option is to evaporate (boil) the water."
Do you agree with this statement?
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View the poll archive. |
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