Outsourcing

Being open to unforseen events may avert risk or create opportunities.

Formulation strategy is an important consideration when selecting and managing outsourced biopharmaceutical development programs.

It is important that all stages of the audit be given an equal measure of attention.

A process harmonization assessment can aid in smooth technology transfer by comparing data across equipment and sites.

Insourcing is new outsourcing. Here's how to do it right.

Partner with a contract manufacturing organization that integrates best practices from project management, customer service, and Lean.

The ability to deal with the complexity of the clinical supply process has shifted the balance of power to clinical supply chain specialists.

Collaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness.

Sufficient process history is key to the rapid transfer of your process.

As facility closures and layoffs continue, CRO and CMO executives are hoping for a better year, despite few positive signs.

A systematic classification system makes supplier quality management feasible, even if you are dealing with hundreds of suppliers worldwide.

A new analysis highlights growth opportunities and challenges for contract development and manufacturing organizations.

An enterprise-wide quality management initiative is required to maintain supplier quality without sacrificing bottom-line objectives.

Lonza's bid for Patheon makes the contract manufacturing industry re-examine the one-stop manufacturer model.

To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc.

To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc.

To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc.

To assess current trends in outsourcing, BioPharm International turned to Mark Douglas, PhD, strategic business development manager, Avecia Biologics Ltd; Geoffrey M. Glass, senior vice president of strategy, corporate development and business integration, Patheon Inc.; Rob Gustines, director of marketing, KBI Biopharma, Inc.; Jon S. Kauffman, PhD, director, method development & method validation and biopharmaceutical services, Lancaster Laboratories; Roger Lias, PhD, president, Eden Biodesign, Inc.; John A. McCarty, vice president, formulation sciences and drug delivery, Azopharma; and Michiel E. Ultee, PhD, vice president, process sciences, Laureate Pharma, Inc.

To assess current trends in cleanrooms and engineering & facilities, BioPharm International turned to Parrish Galliher, founder and chief technology officer, Xcellerex, Inc.; Jim Maslowski, owner, PDC Aseptic Filling Systems; Morgan Polen, vice president, application technology, Lighthouse Worldwide Solutions; and Benoît Verjans, commercial director, Aseptic Technologies.

To select the right partner for media design and optimization services, several key factors must be considered.

Contract research, development, and manufacturing organizations betting on a comeback in venture capital financing will have a long wait.

By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing

UK-based CMOs seek opportunities in new markets.

It is essential to build and maintain a good working relationship between the client and contract research organization.

The current competitive environment is forcing service providers to evaluate their business models and focus on value and performance.

A good understanding of European regulations governing batch release testing will facilitate your collaboration with a contract laboratory.

How to successfully balance patient safety with supply-chain management

Effective tech transfer can save time and effort in later manufacturing processes.

Outsourcing introduces considerable complexity into ensuring compliance with good manufacturing practices. This article offers FDA guidance for how to ensure compliance in the outsourcing environment.

Communication between contract analytical laboratory and client is extremley important when out-of-specification (OOS) results arise.