Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>Resources>White Papers>This White Paper
  White Papers
Scientific News
Making It Personal
Cancer vaccine linked to increased immune response against leukemia cells.
Gene Therapy Maintains Clotting Factor for Hemophilia Patients
Following a single gene therapy dose, the highest levels of an essential blood clotting factor IX were observed in hemophilia B patients.
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Combination Therapy Improved Chemoresistance in Ovarian Cancer
The study demonstrates how an existing class of targeted therapies could be used to potentiate the tumor suppression induced by cisplatin.
Gene Therapy for Blistering Skin Disease Shows Promise
Grafting genetically altered skin onto patients’ chronic wounds marks the first time skin-based gene therapy has been demonstrated to be safe and effective in humans.
Scroll Up
Scroll Down

A Scientific Approach to Good Manufacturing Practices
Bookmark and Share

AMRI

Contract Manufacturing Organizations (CMOs) represent an important and growing industry involved in the manufacture of active pharmaceutical ingredients (APIs) and drug products in a range of dosage forms. By nature of the end use of their manufactured goods, CMOs come under the oversight and responsibility of federal agencies in multiple regions and jurisdictions. These agencies use inspection and enforcement actions to ensure quality compliance and meet their responsibility to protect the public. As quality best practices continue to evolve and improve in response to technology and process advances, as well as in response to public health incidents, federal agencies have continued to challenge the industry to improve its quality compliance and mitigate risk of future incidents occurring. As a result, CMOs exist in an environment of continuous improvement and evolving quality standards that are a requirement of their existence. 

Further Information

Related Content

AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Wednesday, December 16, 2015
AMRI to Close Holywell, U.K. API Manufacturing Facility
Company plans to cease operations at the site by the end of 2015.
Thursday, April 09, 2015
AMRI Announces CFO Transition
Michael M. Nolan, senior vice president and chief financial officer, will be departing AMRI.
Thursday, January 15, 2015
AMRI To Acquire Aptuit Drug Product Development Businesses
Significantly expands AMRI's analytical services capabilities and extends drug product development services to include sterile injectable formulation development.
Friday, January 09, 2015
AMRI to Acquire Oso Biopharmaceuticals Manufacturing
Acquisition significantly expands contract manufacturing capabilities to include commercial scale sterile injectables.
Tuesday, June 03, 2014
AMRI to Acquire Cedarburg Pharmaceuticals, Inc.
Broadens contract development and manufacturing capabilities with high value, complex API business.
Friday, March 28, 2014
AMRI Announces Senior Level Leadership Appointment
The appointment of Michael A. Luther, Ph.D. as Senior Vice President of Discovery sees AMRI expanding its biology capabilities.
Thursday, October 17, 2013
AMRI Awarded Contract from the UK Government
Seven-year contract awarded for the development and manufacture of an active ingredient under clinical evaluation.
Thursday, October 03, 2013
FDA Performs Re-inspection of AMRI Burlington MA Facility
Issues Form 483 for three inspectional observations.
Friday, July 26, 2013
AMRI Burlington Receives DEA Approval to Handle Controlled Substances
Approval to handle Schedule 2 and 2N controlled substances at this location further supports AMRI SMARTSOURCING™ offering.
Wednesday, June 19, 2013
AMRI Promotes Susan Collins to Director, Business Development
Ms. Collins is responsible for leading AMRI’s North American Discovery Business Development team.
Tuesday, June 18, 2013
AMRI Announces Appointment of Chairman of the Board of Directors
Company has appointed William S. Marth as Chairman of the Board, effective June 5, 2013.
Friday, June 07, 2013
AMRI and Ono Broaden SMARTSOURCING™ Collaboration
New agreement extends drug discovery and development collaboration between the companies.
Friday, April 26, 2013
AMRI Announces the Promotion of Richard Saffee
Company promotes Mr. Saffee to Vice President and General Manager of large scale manufacturing.
Wednesday, January 09, 2013
AMRI Announces Five-Year Extension of API Supply Agreement with Shire
AMRI enters into a multi-year supply agreement for an undisclosed product.
Tuesday, October 23, 2012
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!