BioBusiness

A case study compares capital costs, operating expenses, and NPV for a new MAb plant.

Drug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.

Biotech impressed investors with positive drug data, strong drug sales and earnings, and partnering deals.

Ten biopharmaceuticals gained marketing authorization in the US or EU in 2008, although only four were new approvals.

A step-by-step approach is essential for successful implementation.

Small changes can have a big effect further downstream in your manufacturing processes.

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 separation and purification, BioPharm International turned to Mandar Dixit, head of product management?filtration technologies, Sartorius Stedim Biotech; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; Richard Pearce, program director of purification, Millipore Corporation; and Jon Petrone, global technical director, Pall Life Sciences.

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 information technology, automation, and process control, BioPharm International turned to Rick E. Cooley, market development manager?process analytics, Dionex Corporation, and James Erickson, president and chief executive officer, Blue Mountain Quality Resources, Inc.

Recent patent rulings raise significant patentability questions for DNA sequence inventions.

A case study in capturing indirect costs and benefits.

Enabling site-wide process efficiency.

The Bilski and Classen decisions can render numerous in vitro diagnostic claims unpatentable.

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

Although the markets closed on a positive note in May, it will still take many more months before biotech starts on the road to full recovery.

New expression systems compete for attention.

Use Lean techniques to improve manufacturing compliance

How to optimize facility utilization and improve plant performance.

Several legal considerations are key to protect the buyer and seller in royalty interest transactions.

Avoiding healthcare reform is not the best option for the pharmaceutical industry.

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.

Big biotechs will do just fine in the ongoing financial crisis, but the smaller companies will have more difficulty weathering the storm.