Biologic Drugs

Meticulous system configuration can prevent machines from taking over.

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

Holistic open learning networks offer a new drug R&D model for improving research outcomes.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2012 edition from EMD Millipore and Meissner Filtration Products.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Partnerships between industry and academic medical centers are expanding to meet R&D needs.

Does global development have to entail multiple comparability studies?

The Obama administration details five strategic imperatives to drive bioscience research as a means of economic growth.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

With financing constrained, biotechnology firms must find ways to sustain innovation.

How to use geographic diversification and legacy technology transfers to avoid product shortages.

On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.

The divide between innovation and conflict of interest in medical research is not so clear.

Has the long-awaited guidance answered all of the industry's questions?

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

Debottlenecking downstream mAb purification.

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

Challenges remain, particularly for early-stage biopharmaceutical companies.

Technology may expedite operations, but the absence of the human element could cost dearly.

On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.

Pharma companies must balance demand for new drugs while facing reduced R&D spending.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Small drug companies with hopes of achieving $1 billion in sales can pursue various strategies.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.

Average deal size and amounts invested increased in the second quarter, but totals trail funding of last year.

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.