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Asuragen announces agreement to develop and manufacture RNA Control Kits for Affymetrix

Asuragen Inc., a leading molecular biology diagnostic company and service provider, today announced an agreement to develop and manufacture RNA Control Kits for Affymetrix. The RNA Control Kit is intended for use with in vitro transcription (IVT) reagent kits for clinical molecular diagnostic applications that Asuragen has licensed and supplied to Affymetrix.

18 Feb 2010

VPCI pioneers on-demand GMP consultation services for Pharmaceutical manufacturers

Pharmaceutical manufacturers around the world now have access to high-level, FDA support services at the touch of a button. VPCI (Vectech Pharmaceutical Consultants International) has pioneered a "Virtual GMP Consulting" service. Through the use of high definition video conferencing equipment and collaboration software, Pharmaceutical manufacturers now have access to GMP consultation services on-demand, and at a fraction of the cost.

16 Feb 2010

Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capacity projects

Albemarle Corporation, a leading global provider of custom manufacturing services, announced today it will partner with PharmaCore to provide manufacturing capabilities for customers with projects that require high volume capacity.

16 Feb 2010

Positive interim results from Helix BioPharma's Topical Interferon Alpha-2b Phase II pharmacokinetic study

Helix BioPharma Corp. today announced that the first ten patients that have been enrolled in its Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.

14 Feb 2010

Goodwin Biotechnology, Macrocyclics announce collaboration on Chelation and Bioconjugation

Goodwin Biotechnology Inc., a full service Contract Biomanufacturing Company and Macrocyclics, Inc., a manufacturer of customized chelating agents, jointly announced today their collaborative agreement on Chelation and Bioconjugation. The collaboration will strengthen joint customer projects in Nuclear Medicine involving Chelation, Bioconjugation and GMP manufacturing.

10 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

Pall launches PallSep Biotech filtration system

Pall Corporation, a global leader in filtration, separation and purification, has introduced the PallSep Biotech system for the gentle separation of target molecules from complex biotechnology process fluids.

From Pall Corporation 3 Feb 2010

U.S. Marshals seize unapproved ozone generators from Applied Ozone Systems

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

30 Jan 2010

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Regis Technologies, Inc., a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients (APIs) and intermediates, announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) stating that Regis passed the FDA’s pre-approval inspection (PAI) for its manufacture of 4-Aminopyridine the active ingredient in Ampyra™.

29 Jan 2010

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

Sinobiopharma, Inc. is pleased to announce that its production facility for solid dosage Perindopril has passed the required Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.

27 Jan 2010

IntelGenx and LTS announce strategic alliance

IntelGenx Corp. ("IntelGenx") today announced a strategic alliance with LTS Lohmann Therapie-Systeme AG ("LTS") for the exclusive manufacturing of products developed by IntelGenx using its VersaFilm drug delivery technology.

25 Jan 2010

HTDS evaluates business proposal ahead of dividend distribution

Hard to Treat Diseases (HTDS; http://www.htdsmedical.com/) subsidiary Slavica Bio Chem recently announced entry into the stem cell bank development. An unsolicited business proposal is currently being evaluated by the company from an obstetrician type medical company. This company is engaged in a treatment for pre-term labor and induction of labor. These symptoms affect millions of people worldwide.

23 Jan 2010

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

BioLife Solutions, Inc., a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, and OriGen Biomedical, a leading provider of biologic packaging products for research and clinical blood and cell-based therapies, today announced that the companies will introduce sterile standard and custom biologic packaging products pre-filled with BioLife's serum-free, protein-free HypoThermosol® cell and tissue storage/transport media and CryoStor™ cryopreservation media.

21 Jan 2010

AMRI’s Rensselaer labs and manufacturing facilities receive SafeBridge Potent Compound Safety Certification

SAFEBRIDGE® CONSULTANTS, INC., headquartered in Mountain View, California, has announced that AMRI’s high potency research laboratories and GMP-manufacturing facilities in Rensselaer, New York have met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and have been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (“APIs”).

20 Jan 2010

TAP and EPSRC Centre for Innovative Manufacturing in Regenerative Medicine continue collaboration

The Automation Partnership (TAP), a world leader in the design and development of innovative automation for life science applications is pleased to announce that its collaboration with leading translational research group, the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine at Loughborough University is to continue into a second five year phase. This follows the recent announcement by Prime Minister, Gordon Brown and Lord Mandelson, UK Secretary of State, Department for Business, Innovation and Skills of a £5.33 million grant to the centre.

19 Jan 2010

Jiangbo Pharmaceuticals obtains renewal of Good Manufacturing Practices Certificate for Pharmaceutical Products

Jiangbo Pharmaceuticals, Inc. (the "Company" or "Jiangbo"), a pharmaceutical company with its principal operations in China, today announced that one of its factories in China obtained a renewal of its Good Manufacturing Practices Certificate for Pharmaceutical Products ("GMP Certificate") from the State Food and Drug Administration (SFDA) for its tablets and granules.

13 Jan 2010

CEL-SCI completes validation of its GMP manufacturing facility

CEL-SCI Corporation, a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today it has completed the validation of all critical utilities and manufacturing equipment at its GMP manufacturing facility in Maryland.

12 Jan 2010

Pharmaron Holdings acquires Bridge Laboratories China

Pharmaron Holdings Limited, today announced it completed the acquisition of Bridge Laboratories China. Bridge Laboratories China is the leading contract research organization (CRO) in China providing western standard GLP-compliant toxicology services to pharmaceutical and biotech companies from around the world. With this acquisition, Pharmaron becomes the first integrated CRO in China supporting clients with drug discovery and development processes in support of IND filings. This strategic acquisition strengthens Pharmaron's leading position in the fast-growing, highly dynamic pharmaceutical CRO industry.

12 Jan 2010

Laureate Pharma and Iconic Therapeutics complete manufacturing hI-con1 recombinant Fc-Factor VII fusion protein

Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company specializing in the development and GMP manufacture of monoclonal antibodies, fusion proteins and other therapeutic protein products, and Iconic Therapeutics, a company focused on the development of treatments for wet adult macular degeneration (wet AMD) and other ophthalmic diseases, today announced the completion of the manufacture of the first GMP lot of hI-con1(TM) recombinant Fc-Factor VII fusion protein.

8 Jan 2010

DBA Analytical to host a 2-day training course on dietary supplements

DBA Analytical, an NSF International company, which provides a full range of compliance services for FDA regulated industries, will host a 2-day training course on 21 CFR 111, the Current Good Manufacturing Practices (cGMPs) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

6 Jan 2010

GMP News and Research

Asuragen announces agreement to develop and manufacture RNA Control Kits for Affymetrix

VPCI pioneers on-demand GMP consultation services for Pharmaceutical manufacturers

Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capacity projects

Positive interim results from Helix BioPharma's Topical Interferon Alpha-2b Phase II pharmacokinetic study

Goodwin Biotechnology, Macrocyclics announce collaboration on Chelation and Bioconjugation

AMRI announces fourth-quarter and full-year 2009 results

Pall launches PallSep Biotech filtration system

U.S. Marshals seize unapproved ozone generators from Applied Ozone Systems

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

IntelGenx and LTS announce strategic alliance

HTDS evaluates business proposal ahead of dividend distribution

BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

AMRI’s Rensselaer labs and manufacturing facilities receive SafeBridge Potent Compound Safety Certification

TAP and EPSRC Centre for Innovative Manufacturing in Regenerative Medicine continue collaboration

Jiangbo Pharmaceuticals obtains renewal of Good Manufacturing Practices Certificate for Pharmaceutical Products

CEL-SCI completes validation of its GMP manufacturing facility

Pharmaron Holdings acquires Bridge Laboratories China

Laureate Pharma and Iconic Therapeutics complete manufacturing hI-con1 recombinant Fc-Factor VII fusion protein

DBA Analytical to host a 2-day training course on dietary supplements

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