Feb. 24, 2006
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News

GPhA Seeks Additional ODG Funding, Not User Fees

The Generic Pharmaceutical Association (GPhA, Washington DC) says that more funding for US Food and Drug Administrations' Office of Generic Drugs (OGD, Rockville, MD) would produce more benefits than the agency's proposal for generic-maker user fees. (More)

Drug Sales Up 5.4%...But Growth Rate Slowing

As IMS Health (Fairfield, CT) is reporting that prescription drug sales grew by 5.4%, a task force of the federal Centers for Medicare and Medicaid Services (CMS)  reports that the spending-growth-rate is falling, thanks to increasing reliance on generics. (More)

Cambrex Reports Loss; Advances Biosciences Business

Reflecting the vagaries of the custom-manufacturing market, Cambrex Corporation (East Rutherford, NJ), a custom manufacturer and provider of life science services and products, reported a full-year 2005 net loss of $129.2 million on sales of $452 million. The results include an $87.2-million goodwill impairment charge and a $35.8-million charge to reduce the carrying value of long-lived assets. The impairment charge mainly stems from weakness in the company’s contract biopharmaceutical process development and manufacturing business. (More)

Warning Letter: Southern Meds

On Feb. 15, the US Food and Drug Administration's  New Orleans’s District Office (New Orleans, LA) posted a Warning Letter to Southern Meds(Biloxi, MS), a compounding pharmacy. (More)

Lonza Plans Biomanufacturing Facility in Singapore

Lonza Group (Basel, Switzerland), a custom manufacturer and fine chemicals supplier, and Singapore’s Bio*One Capital Pte. Ltd. (Singapore), the investment arm of the Singapore Economic Development Board, are investing $250 million to jointly build a large-scale mammalian cell culture plant in Singapore for the manufacture of commercial biopharmaceuticals. The facility will be Lonza’s second large-scale mammalian manufacturing plant. (More)


 
   

Vaccines

FDA Recommends Changes for 2006–2007 Flu Vaccine

The emergence of two new influenza strains has led the US Food and Drug Administration (Rockville, MD) to recommend changes for next season’s flu vaccine. (More)

Baxter Wins Contract to Develop Cell-Based H5N1 Vaccine

The European subsidiary of Baxter International (Deerfield, IL) has won aUK National Health Service contract to develop two million doses of a cell-based candidate H5N1 influenza vaccine and complete delivery of the stockpile this year. (More)

First Phase I Study Proves Safety, Immune Response of Ebola DNA Vaccine

A Phase I trial conducted on an Ebola vaccine candidate developed by theNational Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD) and administered using proprietary DNA delivery technology from Vical Inc.(San Diego, CA) has shown the vaccine to be safe, well tolerated, and capable of producing both antibody and T-cell Ebola-specific responses in humans. (More)


 

Featured Story

Developments in Powder Flow Testing

The pharmaceutical industry's focus on process understanding, monitoring, and control is driving manufacturers to take greater steps toward identifying possible manufacturing bottlenecks earlier in the development process. For tablet, capsule, and excipient producers, such efforts include taking a closer look at the flow-ability of their powders.

There are only two truths when it comes to powder flow analysis: Powders are a complex material and no one single test method is the best. Everything else is debatable.

The US Pharmacopeia first started working toward standardizing the methods to measure powder flow with a survey and a "Stimuli to the Revision Process" article in Pharmacopeial Forum published in 1999. Since then, a harmonized general information chapter on powder flow has been released for the more traditional methods and sophisticated analyzers have been introduced and are slowly finding their way into pharmaceutical laboratories. (More)


 

In the Spotlight

Ceramic–metal flowmeter

“Batchcontrol” is an electromagnetic flowmeter recently introduced by Krohne (Peabody, MA, www.krohne.com). Batchcontrol’s flow tube is made entirely of a special ceramic that can withstand rapid temperature changes, thus enabling the device to be cleaned or steamed in place. The flowmeter also features cermet (fused ceramic and metal) electrodes, which eliminate gaps in the flow tube.
Joe Incontri, director of sales and marketing for Krohne, says that Batchcontrol also features embedded control of valves. The unit can manipulate as many as six valves without additional commands from the programmable logic control. In addition, Batchcontrol operates on a CANbus network, so it communicates with equipment faster and with fewer cables than other flowmeters. Incontri explains that the network “saves [users] a lot of money and could help them optimize their machine designs in ways they could never do before.”

Correction: The spotlight entry in last week's ePT ran incorrectly. The entry should have read as above.

   

Company News


PLIVA (Zagreb, Croatia, www.pliva.com) signed an agreement with Novartis’s generics division, Sandoz (Holzkirchen, Germany, www.sandoz.com), for the purchase of its Spanish subsidiary Uso Racional S.L. for EUR 21.5 million. The company has also reached a separate agreement with GlaxoSmithKline(Middlesex, UK, www.gsk.com) for the purchase of PLIVA’s proprietary research and development in Zagreb, Croatia.

Excelsyn Group (Newcastle, UK, www.excelsyn.com), a provider of contract manufacturing, consulting, and pharmaceutical engineering services, has acquired a minority stake in Angel Biotechnology Holdings PLC(Cramlington, UK, www.angelbio.com), a provider of process development services and pre-GMP and CGMP manufacturing to the biotechnology and pharmaceutical industries. Excelsyn has been working with Angel through its engineering technology service cluster to build a fermentation facility within Angel’s Cramlington, UK site. This has led to the introduction of biotechnology and biotransformations into Excelsyn’s molecular development cluster and includes the production of unnatural, chiral amino acids. Angel operates two facilities. The Cramlington facility has 750-L fermentation capacity, process development laboratories, and a pilot plant. The GMP-licensed facility in Pentlands Science Park, Scotland has small-scale protein manufacture and stem cell–cellular therapy capabilities.

Evotec AG (Oxford, UK, www.evotec.com), a provider of contract research, manufacturing, and drug discovery services, and Apeiron Biologics GmbH(Vienna, Austria, www.apeiron-biologics.com), a biotechnology company, have formed a discovery collaboration to develop small- molecule assays for pain-relief therapeutics based on research of Josef Penninger, director of the Institute for Molecular Biotechnology of the Austrian Academy of Science.

Degussa Homogeneous Catalysts (DHC), an internal start-up of Degussa AG (Düsseldorf, Germany, www.degussa.com) has launched “catMETium IMesPCy,” a catalyst for olefin metathesis for pharma applications. The catalyst is an alkylidene ruthenium complex with aa N-heterocyclic carbene ligand. The catalyst can be used in cross-metathesis, ring-closing, and ring-opening metathesis. To market this technology, DHC has taken licenses under patents generated by Wolfgang A. Herrmann et al. (Technische Universität München, Germany) and field-of-use licenses under patents generated by Steven P. Nolanet al. (University of New Orleans, LA).

PCAS (Longjumeau, France, www.pcas.fr/eng/index.asp), a custom manufacturer and fine chemical supplier, and Protéus (Nîmes, France,www.proteus.fr), a manufacturer of proteins and bioprocesses, have formed PCAS Biosolution, a joint venture focused on the synthesis of active pharmaceutical ingredients, intermediates, and building blocks, using chemo-biocatalytic manufacturing routes. PCAS Biosolution will have exclusive license rights to the intellectual property platform from both PCAS and Protéus for chemical process development and pharmaceutical manufacturing. Last year, Protéus launched Protéus Services for Industry, a new business unit that provides protein engineering and production services for the life sciences industries.

Sigma-Aldrich Corporation (St. Louis, MO, www.sigmaaldrich.com) has formed a licensing agreement with Rubicon Genomics (Ann Arbor, MI,www.rubicongenomics.com) that allows Sigma-Aldrich to offer “GenomePlex” whole genome amplification kits to service providers. GenomePlex is a proprietary amplification method based on random fragmentation of the genome into a series of overlapping, short templates. Separately, Sigma-Aldrich reported full-year 2005 sales growth of 18.3% to $1.67 billion. Sigma’s 2005 acquisition of JRH’s industrial cell culture business contributed 9.4 percentage points of the annual sales increase.

Arch Pharmalabs (Mumbai, India, www.archpharmalabs.com) announced plans to open a new manufacturing and research and development center with 40,000 ft² of working space in Taloja, India.

People


ISPE (Tampa, FL, www.ispe.org) has appointed Balwant Grewal as vice-president of Asia Pacific operations.

Johnson Matthey Pharma Services (Devens, MA,www.jmpharmaservices.com) has named Paula J. Lorence as director of sales and marketing. Lorence will be responsible for the commercial team, accountable for sales income, marketing intelligence, strategy and communication. Prior to joining Johnson Matthey Pharma Services, Lorence was vice-president of business development and director of analytical chemistry at Ricerca LLC(Concord, OH, www.ricerca.com).

Calendar

February 2006

27–28:Sterilization within the Pharmaceutical Industry,New Brunswick, NJ. Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113,info@cfpa.com, www.cfpa.com

27–28:Root Cause Investigation for CAPA, Amsterdam, Netherlands. Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

27–3/1:Technology Transfer Summit for Pharmaceutical and Biotech Industries, Philadelphia, PA. Contact: International Quality and Productivity Center, 555 Route One South, Iselin, NJ, 08830, tel. 800.882.8684, fax 973.256.0205, info@iqpc.com,www.iqpc.com/pharmaiq

27–3/2:Process Plant Startup, Amsterdam, Netherlands.Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

27–3/3:Aseptic Processing Training Program, Baltimore, MD.Contact: Parenteral Drug Association, 3 Bethesda Metro Center, Suite 1500, Bethesda, MD 20814, tel. 301.656.5900, fax 301.986.0296, info@pda.org, www.pda.org

28: Preparing, Approving, and Implementing Standard Operating Procedures, Toronto, Canada. Contact: Academy of Applied Pharmaceutical Sciences, 200 Consumers Rd., Suite 200, Toronto, ON, M2J 4R4, Canada, tel. 416.502.2277, fax 416.502.2278, info@aaps.ca, www.aaps.com


 

March 2006

1–3: Root Cause Analysis for CAPA, Malvern, PA. Contact: The Center for Professional Innovation and Education, PO Box 488, Southeastern, PA 19399-0488, tel. 610.688.1708, fax 610.688.7817,info@cfpie.com, www.cfpie.com

2–3: Introduction to Good Manufacturing Practices, Princeton, NJ. Contact: Krystle Harb, PTi international, 708 Third Ave., 4th Floor, New York, NY 10017, tel. 212.661.3500 ext. 3184, kharb@pti-international.com, www.pti-international.com

2–3: 2006 PDA Pharmaceutical Anticounterfeiting Forum,Bethesda, MD. Contact: Parenteral Drug Association, 3 Bethesda Metro Center, Suite 1500, Bethesda, MD 20814, tel. 301.656.5900,www.pda.org

2–3: AC Adsorption: Principles and Applications, Orlando, FL.Contact: Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

2–3: Introduction to BioAnalytical Method Development and Validation, Toronto, Canada. Contact: Academy of Applied Pharmaceutical Sciences, 200 Consumers Rd., Suite 200, Toronto, ON, M2J 4R4, Canada, tel. 416.502.2277, fax 416.502.2278, info@aaps.ca,www.aaps.ca

4–5: Selecting the Best AC for a Specific Application, Orlando, FL. Contact: Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

5: AC: Technical and Certification Issues for Treatment Units Containing AC, Orlando, FL. Contact: Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214,http://pacslabs.com

6–7: Documentation Management and Control in the Pharmaceutical and Related Industries, New Brunswick, NJ.Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

6–7: Atomization, Sprays, and Atomizers, Burlingame, CA.Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

6–7: Pharmaceutical Water Systems, Morristown, NJ. Contact:Krystle Harb, PTi international, 708 Third Ave., 4th Floor, New York, NY 10017, tel. 212.661.3500 ext. 3184, kharb@pti-international.com,www.pti-international.com

6–8: Microencapsulation and Particle Coating, New Brunswick, NJ. Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

6–8: Analytical Methods Validation for FDA Compliance, Boca Raton, FL. Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

6–8: GC or HPLC or SCF/E or CE, Orlando, FL. Contact:Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

6–8: High-Pressure Liquid Chromatography, Orlando, FL.Contact: Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

6–8: Supercritical Fluid Chromatography and Extraction,Orlando, FL. Contact: Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

6–10: Pharmaceutical Technology Scool, Mahwah, NJ. Contact:Juan Muzzio, Director of Marketing and Training, Mixing Consultants, PO Box 7012, East Brunswick, NJ 08912, tel. 954.447.6258, fax 954.438.0247, juan@mixingconsultants.com,www.mixingconsultants.com

6–10: Manufacture of Sterile Products, West Lafayette, IN.Contact: Terry S. Couts, Pharmaceutical Technology and Education Center, Purdue University, West Lafayette, IN 47906, tel. 765.494.2701,
tcouts@purdue.edu, www.purdue.edu/dp

6–10: Unit Operations in Solid Dosage Forms, West Lafayette, IN. Contact: Terry S. Couts, Pharmaceutical Technology and Education Center, Purdue University, West Lafayette, IN 47906, tel. 765.494.2701,
tcouts@purdue.edu, www.purdue.edu/dp

7–8: Pharmaceutical Water Systems: Contemporary Technology and Compliance, Dublin, Ireland. Contact: The Center for Professional Innovation and Education, PO Box 488, Southeastern, PA 19399-0488, tel. 610.688.1708, fax 610.688.7817, info@cfpie.com,www.cfpie.com

8: AC Process Systems: Troubleshooting, Operation, and Design of Liquid and Vapor Phase Units, Orlando, FL. Contact:Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

8–10: Drug Product Stability and Shelf Life, Boca Raton, FL.Contact: The Center for Professional Advancement, Box 7077, 44 West Ferris St., East Brunswick, NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com

8–10: Mass Spectral Interpretation, Orlando, FL. Contact:Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

9: AC Particle Enlargement Technologies: Briquetting, Pelletizing, Granulation, and Extrusion, Orlando, FL. Contact:Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, http://pacslabs.com

10–11: Computational Fluid Dynamics and Simulations for Industrial Problem Solving, Orlando, FL. Contact: Professional Analytical and Consulting Services, 409 Meade Dr., Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214,