Manufacturing

The contract provider needs to know as much as the NDA holder.

Greece’s economic crisis has battered the country’s healthcare system, resulting in medicine shortages, market withdrawals and falling profits for the pharma industry.

There are no two completely identical freeze dryer units in operation anywhere.

Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.

Modular factory concepts, which take flexible manufacturing to the next level, are beginning to take hold in the biopharmaceutical industry.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the March 2012 edition from EMD Millipore, ARTMiS, and Powder Systems.

Powder-container design affects discharge rate, cleanability, and powder flow. Flow problems, such as ratholing, arching, and erratic flow, can be eliminated with appropriate container geometry.

In our tablet coating process, we are losing up to 15% of our coating solution in each processing run. What can we do to prevent this problem in order to reduce waste and increase our cost efficiency?

“One of the most daunting challenges facing pharmaceutical companies is securing the long and complex supply chains that are typical in today’s global industry.

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.

GlaxoSmithKline and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in the Asian nation as well as introduce new vaccines.

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

In a world where product recalls can mean the end of a company, all batches must be perfect.

Brazil's generic-drug market is growing steadily.

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.

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

Social media use raises questions about applying old standards to new information technology.

New product reviews for March 2012.

The evolving bio/pharmaceutical business model poses risk for CMOs.

A Q&A with Chris Meissner, president of Meissner Filtration Products, on recent industry trends.

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.

The article examines some recent developments for this process step and for continuous manufacturing overall.

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

This article considers the different conditions to which the powder is subjected in the tableting process, and discusses which powder properties should be measured to accurately reflect likely powder behavior in the process.

Experts in solid dosage discuss the formulation and manufacture of multilayer tablets.

Traditionally more prevalent in less industrialised regions, counterfeit medicines are now more frequently entering the heavily regulated supply chains of EU countries.

Boehringer Ingelheim's Heribert Häusler tells us about parametric release and real-time testing.

Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.

The authors describe a new assembly for bulk and final drug product filling operations.