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Whitepapers & Trade Articles

White Papers

Key Considerations in Choosing a Partner for Drug Discovery (new!)
The goal of having a trusted, reliable, and responsive R&D partner with access to scientific advances and translational expertise is clear. Realizing this ambition can be challenging, though. Details of the best way to choose a partner for drug discovery vary depending on the needs of the company or organizational externalizing the services. There are some key considerations that apply to all alliances. By ensuring a firm meets these criteria before entering into a partnership, drug developers can increase the likelihood of an external partner to meet their expectations.
 
Trends in Quality Agreements & Communications: A CMO Perspective
Outsourcing of all phases of pharmaceutical/biological development and manufacturing continues to rise. As drug development pipelines shift toward those requiring more complex and specialized capabilities, quality agreements and communication planning to avoid non-compliance and the costly ramifications are becoming more important. This whitepaper reviews the FDA draft guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements and provide insights from the contract manufacturing organization (CMO) perspective.
 
Redesigning a chemical library to bolster high-quality hit series identification
Well-designed chemical libraries are a critical tool in the race for drug-discovery in an intensely competitive pharmaceutical marketplace. 
 
How Insourcing Enables Companies to Retake Control, Shorten Cycle Times, and Cut Costs
While many companies enjoy unproblematic outsourcing relationships, there are others that are still struggling to make the benefits outweigh the costs. Stuck between an in-house approach that was ineffective in the past and an outsourced model that is burdensome today, an interest in insourcing continues to expand.

Choosing the Right CMO for HPAPI Manufacturing
Over the past few years a steady stream of contract manufacturing organizations (CMO) have added high potency active pharmaceutical ingredient (HPAPI) production capacity. The expansions give biopharma executives charged with selecting HPAPI production partners an unprecedented number of options. Find out which CMO should you pick when each is touting similar technical capabilities.

As regulatory expectations continue to evolve in the area of pharmaceutical development, working with contract research and manufacturing organizations (CRMOs) that couple execution experience with high-end technical capabilities will ensure the most value from strategic partnerships and enhance a project’s progress on its path toward commercialization. Download “Expedite Development While Ensuring Successful Commercial Outcomes,” written by Darren Hassey, Director, Quality Assurance, AMRI.

As companies within the pharmaceutical and biotechnology space become more reliant on CROs and CMOs to support the development and advancement of their pipelines, a provider’s corporate library can enhance scientific and business performance and help to turn projects around more efficiently. Download the whitepaper, entitled "Evolving Intelligence."

As long time partners in the industry, CROs have been greatly affected by dynamic changes in the universe of available customers and in the competitive landscape. A 2010 whitepaper, written by Thomas E. D'Ambra, Ph.D., chairman, president and CEO, AMRI, explains that to be an effective partner, CROs need to continue investing in facilities, people, equipment, services and technologies in order to meet the increasing needs of an evolving industry. Download the whitepaper, entitled "The Strategic Contributions of Indian Operations in AMRI’s Global Outsourcing Organization."

Trends indicate a return to value as Contract Research Organizations (CROs) continue to grow their skill sets and ally with the global R&D industry to improve pipeline success. AMRI's whitepaper, entitled "Value to the Fore," analyzes various trends in pharmaceutical R&D spending, the increasing demand for R&D outsourcing, and the growing number of skill sets being outsourced.

By scientifically affirming every decision and by embracing integral approaches to quality, contract manufacturing organizations (CMOs) can reduce regulatory risk and become a leader in developing best practices meeting current Good Manufacturing Practices (cGMPs). AMRI's whitepaper, entitled "A Scientific Approach to Good Manufacturing Practices," explores quality system initiatives that support current best practices.

Scientific professionals who are willing to work overseas may gain a competitive advantage when entering or advancing within the drug discovery field. AMRI's whitepaper, entitled "Competitive Edge," comprises viewpoints about how to best prepare for a drug discovery and development career as a global shift drives new trends trends in the area of career development and hiring. 

Trade Articles 

Published in the August 2012 issue of Pharmaceutical Processing, "Around the World with AMRI" highlights AMRI’s global reach in the area of manufacturing and explains in detail how the company uses its assets around the world to provide timeliness, service and quality to its customers.

Published in the November/December 2011 issue of Contract Pharma, "Trace Impurity Identification" highlights AMRI’s rapid protocol used for the isolation and characterization of trace impurities in drug substances and formulated drug products.

Published in the October 2011 issue of Manufacturing Chemist, "Develop an Early Lead with CROs" emphasizes the value of discussing GMP issues early in development.

Published in the September 2011 issue of sp2, "Design and Analysis of HTS Libraries" presents analysis techniques to quantify the composition of an HTS library and highlights methods for establishing structural relationships between compounds in the screening collection.

Published in the June 2011 issue of Nature, "A Natural Choice for Drug Discovery" highlights AMRI's technical capabilities in many aspects of drug discovery, such as biology, natural products and medicinal chemistry.

Read C&EN's October 2011 article, entitled "Bridging the Gap," which features industry insights from Thomas E. D’Ambra, chairman, CEO and president, AMRI.

Industry Journals

In the August issue of Chimica Oggi/Chemistry Today, Ian Shott, AMRI President for Europe and previously founder of Excelsyn, shares his observations on key changes across the outsourcing industry and discusses the potential outlook as pharma companies struggle to regain stability. Download "Current trends and outlook for contract research and manufacturing in Europe."