Dosage Forms

Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.

The vaccine sector is challenging for both R&D and manufacturing because a wide variety of technologies and techniques are required — even the largest companies find it difficult to cover all the relevant areas of expertise — and this drives up development costs and often forces companies into multiple collaborations to obtain the required expertise and technologies.

The Director General of the European Generic medicines Association (EGA) has reiterated the association?s Vision 2015 plan, which aims to create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable healthcare in Europe.

The Director-General of the European Generic medicines Association has reiterated the group's Vision 2015 plan.

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.

Influenza vaccines can be produced faster using a new insect cell-based technology compared with traditional egg-based processes, according to scientists in Vienna (Austria).

Zydus Cadila, a pharmaceutical company based in Ahmedabad, Gujarat, India, will begin conducting trials for a H1N1 vaccine.

A comprehensive book about mass transfer benefits from the author's personal touch.

There is a pressing need to improve the storage stability of currently available vaccines, and achieving this could facilitate mass vaccination campaigns and increase vaccination coverage on a global scale — particularly to underserved and remote regions of the world.

Hospira, a specialty pharmaceutical company, has agreed to acquire Orchid Chemicals' Pharmaceuticals for $400 million.

Also, Abbott to acquire Starlims Technologies; GSK Biologicals to form alliance with Intercell.

Novartis officially inaugurated its large-scale flu cell-culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina.

Also, Merck & Co. extends collaboration with Idera Pharmaceuticals; Pfizer establishes R&D center in China; more...

Leading experts share insight on polymorphism and crystallization.

Generic-drug manufacturers look to expand into biologics and complex dosage forms. This article contains bonus online-exclusive material.

Manual sample preparation methods for solid dose pharmaceuticals have a number of inherent disadvantages, primarily because they are time consuming and unpredictable.

What have been the key innovations that have shaped current aseptic practices and techniques?

Each sector of the pharma industry is fraught with challenges and weighty regulations; aseptic processes and techniques are no exception.

Closed vial technology has been designed to address the challenges - potential contamination, counterfeiting and process complexity - associated with the aseptic filling of injectable drugs.

After further reviewing data on the H1N1 pandemic vaccines approved in Europe, the EMEA has reaffirmed their balance of benefits and risks in the context of the current H1N1 influenza pandemic. Additionally, the World Health Organization (WHO) has issued an update on the H1N1 situation in Europe.

The European Medicines Agency confirmed the safety and efficacy of Focetria and Pandermix, and noted that data on Celvapan are still being analyzed.

GlaxoSmithKline (GSK) has agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Following its $68-billion acquisition of Wyeth, Pfizer has unveiled detailed plans for its global R&D network, which includes consolidation of its R&D facilities.

Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Following the its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) Pfizer detailed plans for its global research and development (R&D) network, which includes consolidation of its R&D facilities.