Outsourcing

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.

"A systematic approach taken by a company involved making an assessment of internal capabilities, strengths, and needs before the selection process."

What the current lack of venture capital means for the CRO market.

How to ensure smooth technology transfers.

In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.

To stave off quality issues associated with production processes, a centralized and enterprise-wide quality management initiative must be enforced.

A closer look at the past year's development in India.

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

If Indian biologics manufacturers can establish a track record for recombinant products, enhance quality image, maintain cost competitiveness, and demonstrate technology transfer and regulatory knowhow, they are likely to be in the middle of the next boom in biologics manufacturing.

When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.

The rapid growth of the pharmaceutical industry in India is yet to create significant changes in the Indian distribution system.