This blog post was written by Christina I. Ortiz of Pharmaceutical Technology.
This year, INTERPHEX was filled with hundreds of innovative exhibitors, but seven companies stood out as leaders of industry as winners of the Facility of the Year Awards (FOYA).
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What can be the future paradigm for continuous manufacturing? Would it be possible to fully integrate manufacturing beginning with the raw materials for an active pharmaceutical ingredient (API) to a finished drug product? How about now? To what extent is continuous manufacturing being applied in the pharmaceutical industry? At a series of discussions at Interphex this week, industry members shared their perspectives on the current and future direction of continuous manufacturing. Read more »
Listeners at today’s live INTERPHEX Signature Series session on China: The New Pharma Frontier, had the opportunity to hear directly from the vice president of the China State Institute of Pharmaceutical Industry (CIPI), Mr. Yu Xiong. CIPI is comparable to the US Pharmaceutical Research and Manufacturers of America (PhRMA). Read more »
Pharma is not dead in Puerto Rico–this was the key message of Victor Merced speaking at INTERPHEX this morning as part of a presentation from the Puerto Rico Industrial Development Company (PRIDCO). There has been some concern among US-based manufacturers that the pharma manufacturing sector’s glory days in Puerto Rico have come to an end, with many companies relocating their facilities to places such as China and India. The Puerto Rican 2010 excise tax on purchases from affiliates hasn’t helped that perspective.
Several sessions at yesterday’s INTERPHEX conference in New York addressed continuous processing and continuous manufacturing. Perspectives from FDA, industry (including Pfizer Global Manufacturing), and academia were presented.
The overall feeling seems to be that batch processing is on its way out and that initiatives such as PAT, QbD, and the new FDA process validation guidance are leading to continuous manufacturing (CM) across industry. Said FDA’s Francis Godwin within DMPQ, “numbers are irrelevant now, it’s all about what you know” about the product and process. Speakers addressed some of the key challenges that come with CM such as scale up and a lack of state-of-the-art equipment for certain processes. But they also talked about the many advantages, such as reducing a company’s footprint and costs. The fact that CM has been used in the food industry for decades helps as well (i.e., regulators know what to look for in certain processses and pharma can borrow from food).
Some questions that are still being worked out include how FDA is going to define a batch versus a lot (the CFR regulations include some verbage), how recalls may be handled with a CM batch or lot, and how to most effectively clean a CM system with regard to startup and shutdown time. FDA’s Moheb Nasr, head of ONDQA within CDER, said that FDA supports CM and that there are no regulations preventing its practice. He advised that companies interested in starting a CM approach call FDA to schedule a discussion to be sure that all parties are on the same page before implementation.
By all accounts, biopharmaceuticals are the supernovae in the pharma firmament. In an article in Pharmaceutical Technology’s August 2010 Outsourcing Resources supplement, for example, Datamonitor’s Bornadata Bain and John Shortmoor suggested that by 2014, sales of small molecules would shrink by $17 billion, while sales of monoclonal antibodies alone would increase by $23 billion. Given that, the editors of Pharmaceutical Technology want to hear from all those in the development and manufacture of biopharmaceuticals about what you produce and how you produce them. Click here to fill out the survey. Responses will be kept confidential, and the results will be published in Pharmaceutical Technology’s May 2011 supplement on Sterile Manufacturing and Bioprocessing. Those of you who complete the survey will have a chance to win a $100 gift certificate.
Big Pharma has offered many explanations for its anemic pipelines. All of the easy drugs have been discovered. Patent law (or another particular form of regulation) stifles innovation. The economy is forcing us to retrench. Although these explanations may be plausible, they all lay the blame elsewhere. Could Big Pharma’s own actions be discouraging research and development (R&D)? Read more »
Outsourcing can have its benefits, but how often do we bother to measure the actual value of our outsourcing relationships? Or the innovation that it delivers? In Europe, at least, the answer is: not very often.
This week, Warwick Business School (UK) released a study (sponsored by Cognizant) looking at European C-suite attitudes to outsourcing. The study encompassed 250 CIOs and CFOs across Benelux, France, Germany, Switzerland, the Nordics and the UK. Read more »
The crises in Japan and Libya this month have drawn attention once again to the outstanding work of many international relief agencies as they work around the clock to deliver needed food, water, supplies, and medicines to civilians. The pharma industry is no exception.
Even more than visiting the exhibit floor, I enjoy attending the presentations at INTERPHEX, which will take place next week in New York. The sessions always reflect the current hot topics within the pharmaceutical industry, and this year is no exception. Observers have been predicting that vaccines will be the industry’s new growth area, so my eye was drawn to the various biopharmaceutical talks listed on the INTERPHEX schedule of events. Read more »
From PharmTech.com