GMP News and Research

RSS

Solos Endoscopy signs agreement with ER for CE Mark Technical File development consulting services

Solos Endoscopy, Inc. is pleased to announce the Company has signed an agreement with Expert Resource (ER) to provide consulting services in support of the Company's CE Mark Technical File development. Before Solos can place the CE Marking on their medical devices and legally sell within the European Union (EU) and Canada, the Company must prepare a Technical File with evidence of compliance to the EU Medical Device Directive.

3 Mar 2010

New treatments for heart disease

Two studies published in the latest issue of Cell Transplantation (18:12) may lead to new treatments for the treatment of heart diseases. The first study, carried out by a team of Brazilian researchers, found that cell transplantation of bone marrow mononuclear cells (BMMCs) directly into the heart benefited patients suffering from refractory angina.

24 Feb 2010

WuXi PharmaTech's Shanghai c-GMP manufacturing facility receives MPA compliance certificate

WuXi PharmaTech (WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that it received the formal certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, acting on behalf of the European Medicines Agency (EMEA), for its c-GMP drug product manufacturing and analytical testing facilities located in Shanghai.

24 Feb 2010

Chiltern International and Charles River Laboratories to study radiolabelled drug products

Chiltern International Limited, a global contract research organization (CRO), announced its latest collaboration with Charles River Laboratories, Inc. As part of this collaboration, Chiltern Early Phase will partner with Charles River to conduct and support early phase radiolabelled studies.

22 Feb 2010

PsychoGenics announces alliance with experimental neuropharmacology expert for specialized microdialysis services

PsychoGenics Inc. today announced the establishment of an exclusive alliance with Dr. Jan Kehr, an internationally recognized expert in experimental neuropharmacology, to provide specialized microdialysis services to complement PsychoGenics’ in vivo testing capabilities.

19 Feb 2010

Epeius Biotechnologies completes construction of VPU to manufacture targeted genetic medicines

Epeius Biotechnologies (www.epeiusbiotech.com) announces the completion of the design engineering and construction phase of a state-of-the-art Vector Production Unit (VPU) for the commercial manufacturing of its advanced targeted genetic medicines. In accordance with an FDA Critical Path initiative, which encourages innovation and the implementation of new technological advances in GMP, CMC, aseptic processing, and quality control, the Epeius VPU is poised to launch the large-scale production of targeted genetic medicine into the 21st century.

18 Feb 2010

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