Biologic Drugs

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

A path to personalized medicines creates a new paradigm for development and manufacturing.

The performance of biotechnology venture capital and investment is lackluster at best.

More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.

Academic–industry partnerships are increasingly important in biopharmaceutical innovation.

An uncertain regulatory environment affects funding for biotechnology.

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Alfa Laval and GE Healthcare.

Deep process characterization and "lab-on-a-chip" enable SMART bioprocess design.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential.

Drugmakers hatch new manufacturing paradigms in the wake of the 2009 H1N1 influenza pandemic.

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

The generic-drug company Actavis (Hafnarfjordur, Iceland) is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings (Barr, Switzerland) from Bioton, a Polish biotechnology company.

The author describes the types and sources of rouge and explains ways to prevent and mitigate this problem.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

In light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.

The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.

We speak to The European generic Medicines Association about the environment for biosimilars.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

Editors' picks of pharmaceutical science and technology innovations.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

Analysis of the opportunities and challenges in the biosimilars market.

The second annual Pharmaceutical Technology Bioprocessing Survey offers a snapshot of the industry following 2009's megamergers.