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 Workstation enables control of strong reactions
Mettler Toledo’s (Zürich) RC1e process-safety workstation enables users to assess and control chemical reactions for creating active pharmaceutical ingredients. The workstation is based on heat-flow calorimetry, and its integrated measuring devices provide accurate and reproducible measurements of process parameters such as temperature, pressure, and pH. The unit tracks heat data in real time and allows users to optimize process parameters while a reaction is in progress.
Using information collected by the thermostat, the system calculates data such as heat transfer coefficients, specific heats, heat-flow rates, and thermal accumulation. The workstation converts basic data into crucial safety information. The safety runaway graph describes failure scenarios and helps users avoid runaway reactions, and a graph indicates the process’s level of criticality.
The system is controlled by flexible software that integrates with online analytical tools. Operators can run predefined, automated procedures; directly control individual process steps with the system; or combine both approaches.
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Accentia Biopharmaceuticals (Tampa, FL) signed a deal with Baxter Healthcare (Deerfield, IL) to provide Accentia with the exclusive, worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of autoimmune diseases including multiple sclerosis. Cyclophosphamide is the active drug used in Revimmune therapy, Accentia’s proprietary system-of-care in development for the treatment of a broad range of autoimmune diseases. Baxter will be Accentia’s sole source of cyclophosphamide for Revimmune.
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Almac (Craigavon, UK) added a dedicated late-stage customization suite to the company’s commercial facilities. The addition is designed to assist orphan drug and niche product launches in Europe.
BioDelivery Sciences International (BSI, Raleigh, NC), a specialty pharmaceutical company, announced that manufacturing of Onsolis (fentanyl buccal (transmucosal)) has resumed after a brief, voluntary shutdown at Aveva Drug Delivery Systems (Miramar, FL), the contract manufacturer for Onsolis. As BSI had previously announced, the halt in manufacturing was due to the US Food and Drug Administration’s concerns about Aveva’s manufacturing conditions and not due to issues with the drug Onsolis.
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Dr. Reddy’s Laboratories (Hyderabad, India) will purchase GlaxoSmithKline’s (London) oral penicillin facility in Bristol, Tennessee, and rights to the Augmentin (amoxicillin clavulanate) and Amoxil (amoxicillin) brands in the United States. GSK will retain the existing rights for these brands outside the US. This transaction is targeted to close within the first half of the calendar year 2011. Financial terms were not disclosed.
GlaxoSmithKline (GSK, London) agreed to increase its stake in the biopharmaceutical company Theravance (South San Francisco, CA) with the purchase of 5,750,000 shares of Theravance common stock at a price of $22.50 per share, for a total investment of $129,375,000. Following this purchase, GSK will own approximately 19% of the total outstanding capital stock of Theravance. The companies entered into a long-acting beta2 agonist (LABA) collaboration in 2002 to develop treatments for respiratory disorders.
In a separate announcement, GSK said it formed an alliance with JSC Binnopharm (Moscow) to enable the local secondary manufacture of a number of GSK vaccines in Russia. GSK will supply bulk vaccine and provide technology and expertise to enable Binnopharm to undertake the secondary
manufacture, including filling and packaging of GSK vaccines in accordance with international current
good manufacturing practice (CGMP) standards. Binnopharm will be responsible for gaining approval of its facilities to allow supply of GSK cervical cancer, rotavirus, and pneumococcal vaccines under Binnopharm’s trademark for the Russian public market. Financial details were not disclosed.
KemFine (Helsinki), a fine and specialty chemicals company, has sold its UK unit, KemFine UK, to Aurelius, a Munich, Germany-based holding company. Financial terms were not disclosed.
Lonza (Basel) and California Peptide Research (CPRI, Napa, CA), formed an agreement to provide peptide manufacturing and development services. CPRI adds geographic diversity to Lonza's existing facilities in Braine-l'Alleud (Belgium), Visp (Switzerland), Nansha (China), and Kourim (Czech Republic). CPRI’s offering includes milligram- to multi-gram-scale custom synthesis, a variety of catalog products, as well as consulting services and technical support.
In a separate announcement, Lonza said it formed an agreement with Dalton Pharma Services (Toronto) to provide early-phase chemistry and kilogram-laboratory manufacturing services for small molecules. Dalton offers contract chemistry research, contract analytical services, and chemical synthesis up to CGMP kilogram-scale as well as small-scale fill-finish activities at its site in Toronto, Canada.
Lubrizol (Wickliffe, OH), a specialty chemical company, opened a regional applications and business center in Mumbai, India, to support its advanced materials business segment. The laboratory includes development, formulation, and applications testing capabilities in multiple personal care and coatings applications as well as a pharmaceutical application development center. The site also supports Lubrizol’s business in engineered polymers.
NanoBio (Ann Arbor, MI) received a $6 million grant from the Bill & Melinda Gates Foundation to support the development of an intranasal vaccine for respiratory syncytial virus (RSV). RSV is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia, as well as the number one cause of childhood hospitalization both in the United States and around the world, according to a company press release. Currently, there are no approved vaccines for RSV.
The Life Science Services division of SGS (Geneva, Switzerland), a provider of inspection, verification, testing, and certification services, will invest EUR 2.1 million ($2.9 million) in its facility in Poitiers, France, to expand the analytical services for biopharmaceuticals such as recombinant proteins, monoclonal antibodies, vaccines, synthetic peptides, and oligonucleotides. During the next year, SGS will add an additional 5400 ft2 of new laboratory space dedicated to bioanalysis. The company also plans to upgrade equipment and add 50 scientist positions at the site.
Xanodyne Pharmaceuticals (Newport, KY) agreed to withdraw its prescription pain products Darvon and Darvocet (propoxyphene) from the US market following new clinical data and a request from FDA. The agency also requested generic manufacturers of propoxyphene-containing medicines to voluntarily withdraw their products too. Clinical data showed a risk of potentially serious or even fatal heart rhythm abnormalities with use of the drug.
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Aushon BioSystems (Billerica, MA), a provider of microarray products and laboratory services for biomarker analysis, appointed Sven Beushausen as chief scientific officer.
Covance (Princeton, NJ), a provider of drug-development services, promoted Rick Cimino to executive vice-president and group president of clinical development, Deborah Tanner to executive vice-president and group president of research and development laboratories, and John Watson to corporate senior vice-president and president of strategic partnering, and chief commercial officer. The company also appointed Jon Koch as corporate vice-president and president of central laboratory services and Lisa Uthgenannt as corporate vice-president of human resources.
Hospira (Lake Forest, IL), a specialty pharmaceutical and medication-delivery company, named Francois (Frans) L. Dubois to the newly created position of senior vice-president of quality, effective Jan. 3, 2011. He will report directly to Christopher Begley, chairman and CEO.
The board of directors of Merck (Whitehouse Station, NJ) elected Kenneth C. Frazier, currently Merck's president, as CEO and president, as well as a member of the board, effective Jan. 1, 2011. Frazier will succeed Richard T. Clark, who has served as Merck's CEO since 2005 and will continue as chairman of the board.
Stem Cell Therapeutics (Calgary, Canada), a biotechnology company, appointed Allen Davidoff as the company’s chief scientific officer. Davidoff’s current position as vice-president of product development will end on Dec. 31, 2010, per a previous announcement by the company. Also leaving the company on that date is Alan Moore, president and CEO. The company will search for a new president and is expected to name an interim CEO.
CEO Martin Nicklasson will leave Swedish Orphan Biovitrum (Stockholm), an orphan-drug niche specialty-pharmaceutical company. Kennet Rooth, currently head of marketing and sales, will assume the position of interim CEO while the company searches for Nicklasson’s replacement.
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In European regulatory news, the European Medicines Agency (EMA) published a new policy
this week regarding public access to its documents about drugs for human and veterinary use. The policy is part of EMA’s response to increasing public demand for more openness and transparency, according to a release from the agency. FDA launched the first phase of its transparency initiative early this year. The specifics of EMA’s plan include releasing documents concerning drugs after a procedure has been finalized, giving access
to all business-related documents (unless there is a need to respect other privacy arrangements), and releasing non-confidential sections of documents submitted to the agency as part of a marketing authorization application such as clinical-trial reports (after the application has been finalized, that is). Any information that is confidential within marketing applications will be redacted to protect personal and commercial data. The new policy will be implemented in two phases, the first being the reactive disclosure of documents in response to written requests.
EMA also released a draft guideline last week on similar biological medicinal products containing monoclonal antibodies. The guideline specifies requirements for medicines containing mAbs that claim to be similar to another such medicine already marketed. Comments on the draft are due May 31, 2011.
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Trade Show Attendance
Did you attend more industry trade shows/conferences this year compared with recent years?
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