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News
Inhaled
Insulins Win Approval: Pfizer in the US, Generex in South
America
With
a Feb. 1 US
Food and Drug Administration
(Rockville, MD, www.fda.gov) approval
of Pfizer’s
(New York, NY, www.pfizer.com)
“Exubera” (insulin human [rDNA origin]) inhalation powder to treat
adults with type 1 and type 2 diabetes became the first inhaled insulin
okayed for marketing in the United States, but the second marketed
worldwide. (More)
Cell-Grown
Vaccine Protects Against Avian Flu Virus
University
of Pittsburgh
(www.upmc.com) researchers have
genetically engineered an avian flu vaccine from the critical components
of the H5N1 virus, and shown that the vaccine completely protected mice
and chickens from infection. (More)
Eggs
from Transgenic Hens Express Interferon Beta-1a Protein
Researchers
at Oxford
BioMedica
(Oxford, UK, www.oxfordbiomedica.co.uk),Viragen
Ltd.
(Plantation, FL, www.viragen.com),
and Roslin
Institute(Edinburgh,
Scotland, www.roslin.ac.uk) have
expressed interferon beta-1a in the whites of eggs laid by transgenic
hens. Interferon-beta is a key component of the human immune system and
is the active ingredient in several multiple sclerosis therapies.
(More)
Dow
AgroSciences Receives Regulatory Approval for Plant-Made
Vaccine
Dow
AgroSciences LLC
(Indianapolis, IN, www.dowagro.com), a wholly owned
subsidiary of The
Dow Chemical Company
(Midland, MI, www.dow.com), has
received regulatory approval for a plant-cell-culture-derived vaccine
from the US Department of Agriculture Center for Veterinary Biologics.
(More)
SAFC
Launches SAFC Supply Solutions
SAFC
(St. Louis, MO, www.safcglobal.com), the custom
manufacturing arm of the Sigma-Aldrich
Group
(St. Louis, MO, www.sigmaaldrich.com), has
launched a new entity, “SAFC Supply Solutions,” which combines its
specialties business with the former Proligo Reagents’ manufacturing
site in Hamburg, Germany. (More)
Albany
Molecular Research To Acquire ComGenex
Albany
Molecular Research Inc.
(Albany, NY, www.albmolecular.com), a provider
of chemistry services to the pharmaceutical and biotechnologies
industries, has signed a stock purchase agreement to acquire
ComGenex(Budapest,
Hungary, www.comgenex.com), also a
provider of contract chemistry services to the life sciences industry.
(More)
Lonza
Plans Biologics Manufacturing Expansion
Lonza
(Basel, Switzerland, www.lonza.com),
a custom manufacturer of small molecules, intermediates, and biologics,
is planning to expand its biologics manufacturing facility in
Portsmouth, New Hampshire, to provide new mid-scale capacity. The
groundbreaking for the 5000-L reactors is scheduled for April 2006.
(More)
FDA
Releases Guides to Dissolution Testing and Quality Overall
Summary
On
Jan. 31, the US
Food and Drug Administration
(Rockville, MD, www.fda.gov) released
two sets of documents: From the Office of Generic Drugs came the
Model
Quality Overall Summary, a
36-page illustration of what the newly instituted Quality Overall
Summary (QOS) for generic products should look like. And from the Office
of Testing and Research came “Mechanical
Qualification of Dissolution App. 1 & 2,”
an eight-page guide to the set-up, mechanical calibration, and operation
checks for dissolution testing devices, along with sample
calibration-reporting sheets.
In
the Spotlight
 Modular
LC system increases throughput
Agilent
Technologies
(Palo Alto, CA,www.agilent.com)
has announced the release of its “1200 Series” liquid chromatography
(LC) system. Christina Maehr, Agilent’s launch coordinator for the 1200
Series, asserts that it is “the only LC platform on the market that can
be used for all applications from nanoscale to prep” because of its
modular design.
Other
advantages include the series’s automated column-regeneration
technology, which allows users to start a sample run before a previous
run has completed, thereby increasing throughput to as many as 2000
samples per day. Maehr claims the 1200 Series is 2–3 times faster than
its chief competitors, partly because of its relatively high pressure of
600 bar.
In
addition, five new high-performance LC chips can be used with the 1200
Series. Maehr says the chips reduce the number of fittings and
connections by more than 50% compared with a conventional LC system.
Customers using the chips, which provide new functionality such as
small-molecule applications, have reported a three-thousandfold
improvement in sensitivity.
Company
News
Six pharmaceutical
manufacturing facilities have been selected for recognition in the
second annual Facility of the Year Award competition sponsored by ISPE
(Tampa FL, www.ispe.org), INTERPHEX
(www.interphex.com) andPharmaceutical
Processing magazine. The
finalists are: AstraZeneca(Macclesfield, UK),
Baxter
BioPharma Solutions (Bloomington, IN),
Daiichi
Asubio Pharma Co., Ltd. (Tokyo, Japan),
Janssen
Pharmaceutica (Geel, Belgium), and
Wyeth
Pharmaceuticals (Dublin, Ireland).
Biolex
Therapeutics (Pittsboro, NC) was
selected for special merit recognition. The winner of the 2006 Facility
of the Year Award competition will be announced March 22 at the
INTERPHEX Conference and Exhibition at the Jacob K. Javits Convention
Center in New York City.
Patheon (Mississauga,
Ontario, Canada, www.patheon.com) has entered into a
five-year master supply agreement with Merck (Whitehouse Station,
NJ,www.merck.com) to provide
commercial manufacturing and pharmaceutical development services to the
company. Merck also selected Patheon as one of its strategic partners
for commercial manufacturing and pharmaceutical development
services.
Nastech
Pharmaceutical (Bothell, WA,
www.nastech.com) and Procter &
Gamble Pharmaceuticals, (Cincinnati, OH, www.pg.com), will collaborate to
develop and commercialize Nastech’s parathyroid hormone nasal spray for
the treatment of osteoporosis. Under the terms of the agreement, Nastech
will grant Procter & Gamble rights to the worldwide development and
commercialization of the nasal spray in exchange for an upfront fee,
milestone payments, and royalties on product sales.
Par
Pharmaceutical (Woodcliff Lake, NJ,
(www.parpharm.com) has
divestedFineTech
Laboratories (Haifa, Israel,
www.finetech.co.il), which Par acquired
in 2002.
People
Carlo
Montagner will join
Abraxis
BioScience, Inc., as president of the
company's proprietary operating division, Abraxis Oncology. Pending
completion of the merger of American
Pharmaceutical Partners (Schaumburg,
IL,www.appdrugs.com) and American
BioScience (Santa Monica, CA),
Montagner will serve as president of American BioScience's commercial
development division to lead the worldwide commercialization efforts for
its "Abraxane" anticancer therapy.
PhRMA (Washington DC,
www.phrma.org) named Conan
Grames as the trade group’s
senior vice-president and general counsel.
JRS
Pharma LP (Patterson, NY,
www.jrspharma.com) named Alen
B. Guy to the new position
of vice-president of research and development and commercial
development.
Calendar
February
2006
6–7:Sterilization
in the Pharmaceutical Industry, Amsterdam,
Netherlands. Contact:
The Center for
Professional Advancement, Box 7077, 44 W. 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, San Diego, CA.
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:Powder
and Bulk Solids Handling Courses, Las Vegas, NV.
Contact:
Jenike and Johanson,
One Technology Park Drive, Westford, MA 01886-3189, tel. 978.392.0300,
fax 978.392.9980,mail1@jenike.com, www.jenike.com
6–8:Emulsion–Suspension
Technology, New Brunswick,
NJ.Contact:
The Center for
Professional Advancement, Box 7077, 44 W. Ferris St., East Brunswick,
NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com
6–10:Pharmaceutical
Quality Assurance and Control, Boca Raton, FL.
Contact:
The Center for
Professional Advancement, Box 7077, 44 W. Ferris St., East Brunswick,
NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com
7–8:Validation
of Computer Systems, 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
7–8:Writing
Reports for Failure Investigations and Process
Deviations, Boston, MA.
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
8–9:Complying
with FDA Requirements for Labeling and Packaging, Philadelphia, PA.
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
8–10:Pharmaceutical
CGMPs and FDA Inspections, New Brunswick, NJ.
Contact:
The Center for
Professional Advancement, Box 7077, 44 W. 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, Las Vegas, NV.
Contact:Barbara Sherman,
Professional Analytical and Consulting Services, 409 Meade Drive,
Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax
724.457.1214, Barbpacs@aol.com,http://pacslabs.com
9–10:Process
Validation for Drugs and Biologics, 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
13–14:CMC
Submissions in CTD Format, New Brunswick,
NJ.Contact:
The Center for
Professional Advancement, Box 7077, 44 W. Ferris St., East Brunswick,
NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com
13–15:Nonclinical
Drug Safety Evaluation and Drug Development, New Brunswick, NJ.
Contact:
The Center for
Professional Advancement, Box 7077, 44 W. Ferris St., East Brunswick,
NJ 08816-7077, tel. 732.238.1600, fax 732.238.9113, info@cfpa.com, www.cfpa.com
14–15:Comprehensive
Overview of FDA Regulatory Compliance for Drugs and Biotech
Products, 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
14–16:
Fifth
Pharmaceutical Powder X-ray Diffraction Symposium,
Somerset,
NJ.
Contact:
International Centre
for Diffraction Data, 12 Campus Blvd., Newtown Square, PA 19073-3273,
tel. 610.325.9814, fax 610.325.9823, info@icdd.com,www.icdd.com/ppxrd
14–17:
Informex
2006,
Orlando,
FL.
Contact:
CMP Information,
tel. 415.947.6348, fax 415.947.6020, kpistochini@cmp.com,www.informex.com
(For
full calendar)
Pharmaceutical
Technology Sourcing and Management—
January 2006
Feature
Overcoming
the Challenges of Offshore Pharmaceutical Production
Michael
Webster
(For
full issue)
Current
Print Issue—February 2006
Special
Report
Developments
in Powder Flow Testing
Maribel
Rioss
APIs
& Fine Chemicals
SOCMA
Launches ChemStewards Program: New EHS&S Program Is
Underway
Patricia Van
Arnum
Drug
Development
Enhancing
Drug Development by Applying LC–MS–MS for Cleaning Validation in
Manufacturing Equipment
Kevin J. Kolodsick,
Holly Phillips, Jennifer Feng, Matthew Molski, and
Carol A.
Kingsmill
Manufacturing
Enhancement
of Xcelodose Capsule-Filling Capabilities Using Roller
Compaction
Deanna Mouro, Robert
Noack, Bruce Musico, Harry King, and Umang Shah
Drug
Delivery
Nanoparticle
Technology for the Delivery of Poorly Water-Soluble
Drugs
Vivek Kharb,
Meenakshi Bhatia, Harish Dureja, and Deepak Kaushik
Viewpoint
On-Demand
Information: The Future Is Now for Pharmaceutical
Manufacturing
David
Besemer
Agent-In-Place
Sweet
Mix-Ups and Sour Data
Control
Washington
Report
User
Fees, Drug Safety: Top Priorities for FDA
Jill
Wechsler
Outsourcing
Outlook
New
Endings Begin the New Year
Jim
Miller
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FDA fires the starting gun for Exubera
