Weekly Pharma Manufacturing News Roundup — September 30, 2014

Implementing A Risk-Based Approach For High Tox Manufacturing

A Pharmaceutical Processing article discusses the factors that are driving the future of high toxic pharmaceutical manufacturing. In particular, the article highlights a risk-based approach for manufacturing pharmaceutical products for pharma and CMOs planning to expand or add high-potency API manufacturing capacity to their offerings. The article breaks down the risk-based approach into three categories: Hazard characterization, OEL Setting, ADE setting, and Hazard Bands.

10 Disruptive Trends Altering Future Of Healthcare

The IMS Institute for Healthcare Informatics has identified 10 recent “harbingers” that are forcing the current healthcare system to change. Several of these disruptions include: the growing development of new malaria and dengue vaccines that will advance distribution infrastructure, and improve procurement and supply chain management systems; the increasing usage of biologic medicines in pharmerging countries; and the consolidation of purchasing groups that are encouraging generic manufacturers to differentiate their offerings, either through proprietary formulations, new delivery mechanisms, or services.

Pharma Manufacturing “Vertical Disintegration”: A Distant Reality

An article from the Kurmann Partners’ newsletter titled “Pharma Manufacturing — A Long Way To Lean Structures” addresses the expectations that, as outsourcing of pharma manufacturing increases, so too will the industry begin consolidating its manufacturing networks. However, the article highlights some of the financial records of Big Pharma, which do not suggest that companies have begun to consolidate “far-flung manufacturing networks,” nor do they suggest that outsourcing has become a fundamental part of the manufacturing process. Therefore, Kurmann Partners expect that the “vertical disintegration of the Pharma manufacturing networks” is still a work in progress and that it will be some time before CMOs begin seeing exponential growth in their outsourcing business.

FDA’s Social Media Guidance Gets Some Industry Kickback

The comment period for the FDA’s most recent draft guidance on the use of social media in pharma recently closed, however according to The Hill, members of the industry still believe the guidance has a long way to go. The Hill reports that pharma manufacturers are primarily concerned the FDA would hold the company responsible for any incorrect information that third parties would post online about the companies’ products. If this is the case, pharma believes this would alienate the industry from consumers, as the current draft guidance would keep companies from interacting on social networks and would leave consumers in the dark about specific medical products. 

Interview Highlights API Manufacturing Trends, Peptide Possibilities

Outsourced Pharma’s own Ed Miseta recently interviewed Davuluri Saharsh Rao, director & president of Contract Research at Neuland Laboratories about current trends in API manufacturing. According to Rao, the industry needs to divide the API market into two categories: one being the generic API market, and the other is the manufacturing of APIs for new drugs being developed concurrently (called the contract business). Rao also provides some information about the movement of generics and API manufacturing overseas, as well as the growth of and opportunities in peptide manufacturing.

Biopharm And Vaccine Manufacturing Market On The Rise

According to a new Kalorama Information report, the biopharmaceutical manufacturing market is on the rise. In 2013, the global market was worth $36.8 billion, driven in part by an increased demand for specialized contract manufacturing due to new drug commercialization, among other factors. The report singles out commercial scale systems that are based on familiar mammalian cells and E. coli as the dominating force in the manufacturing realm until the end of 2018.