Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions. Are you involved with machinery and equipment for solid dosage or parenteral products? Click here to take the survey. Read more »
President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation. So how has the pharmaceutical industry responded?
A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.
Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.
We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!
Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized. At the PDA/EMA joint conference, which took place earlier this month, Martin Wunderlich from F. Hoffmann-La Roche presented an industry case study on solid drug product manufacturing based on this concept. He explained how a continuous wet granulation process for one of the company’s product (referred to as ‘product X’ hereafter) was developed using a quality-by-design (QbD) approach and a control strategy based on process analytical technology (PAT), as well as the technical challenges involved in the development of the process. Read more »
The biopharmaceutical industry is increasingly turning to disposable, single-use systems that offer flexibility and cost benefits. This trend was evident at the Interphex 2012 exhibit in New York earlier this month in the disposable systems and components that were prominent in many booths. Exhibitors commented that disposable systems were unheard of at Interphex as little as six years ago, but now they are everywhere. Read more »
Earlier this week I read a great article on Reuters about how pharma companies are looking to the automobile industry for innovation by transferring some of the lean methodologies learned in car manufacturing to pharmaceuticals. As a pharmaceutical journalist, I read a lot of news stories and articles about innovative new products, R&D projects and partnerships, and sometimes it’s too easy to let your eyes gloss over these as everyday business. Earlier this year though, the partnership between GlaxoSmithKline the McLaren Group really grabbed my attention. Pharma… and a racing-car maker? That’s definitely not an everyday occurrence. Or is it? Read more »
A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »
When only a handful of manufacturers supply a given drug, production problems at any of those companies can lead to a shortage. Earlier this year, problems at Ben Venue’s Bedford, Ohio, site contributed to shortages of the cancer drug Doxil. The shortages are likely to continue now that Ben Venue has suspended manufacturing at the plant. Read more »
Topical drugs are an important sector in the pharmaceutical market, particularly as pharmaceutical companies seek innovative ways to improve drug delivery and patient compliance. An upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »
The Department of Health and Human Services released a report containing its analysis of the causes of the escalation in drug shortages seen over the past few years. The report, from the Assistant Secretary of Planning and Evaluation’s Office of Science and Data Policy, coincided with an executive order issued by the White House directing FDA to take specific steps to predict and prevent the drug shortages that have been escalating over the past few years. Read more »