Dosage Forms

In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.

Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.

Vibrational spectroscopy, which encompasses near-infrared, mid-infrared and Raman spectroscopy, is an important analytical tool in the pharma industry.

Florian Krammer explains how a novel technology using insect cells can accelerate the manufacture of pandemic influenza vaccines.

Three companies joined the University of Pittsburgh Medical Center's 21st Century Biodefense initiative to establish a flexible vaccine development and production facility.

There are a variety of vaccine types, each varying in safety and efficacy, and each possessing its own formulation challenges. To overcome potential instabilities when developing vaccines, one formulation strategy is to produce a dried product.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

In Part I of this article, the authors describe the materials and methods used in developing a screening strategy to accelerate the preparation and characterization of spherical agglomerates by spherical crystallization.

Analysis of the opportunities and challenges in the biosimilars market.

Technological developments make it easier to manufacture sterile parenterals.

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

Drugmakers have many incentives to avoid overfilling their containers, including the scarcity, and correspondingly high cost, of certain cells and ingredients. These concerns highlight the need for techniques that can fill small volumes of product with great accuracy. Many strategies are available to the industry, but which one works best?

Figures published by the European Medicines Agency (EMA) relating to centralized procedure activities for human medicines show a significant increase in the number of positive opinions made between 2007 and 2009; however, the majority of approvals are for generic products.

EMA statistics highlighting centralized-procedure activities for human medicines show a significant increase in positive opinions made between 2007 and 2009.

Capsules that can release their contents at a selected temperature have been developed by researchers in France, and could lead to the development of therapeutic agents that are applied to the skin and triggered locally by rubbing.

Hoping to prevent the deaths of eight million children over the next decade, Bill and Melinda Gates recently committed $10 billion for child-immunization programs in the world's poorest countries.

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...