INTERPHEX, in conjunction with Pharmaceutical Processing, presents INTERPHEX Live! During this INTERPHEX Live! video conference Catherine Sbeglia, Associate Editor of Pharmaceutical Processing, interviews Dan Sorgen, Head of U.S. Supply Chain and Distribution Quality at Genentech Inc. about the cold chain, its significance in pharmaceutical development, some of the biggest challenges and opportunities faced, how products are monitored during transport, and other key…
INTERPHEX Live!: FDA Inspection Preparations—What’s New, What’s Different
INTERPHEX, in conjunction with Pharmaceutical Processing, presents INTERPHEX Live! During this INTERPHEX Live! video conference Russ Somma, Ph.D., President of SommaTech LLC, an affiliated consulting company of IPS, interviews Joe McGinnis, Senior Regulatory Compliance Advisor, Johnson & Johnson; Mark Rezak, Director, Compliance Consulting, IPS-Integrated Project Services; and Anthony Castellazzo, Senior Director of Quality Assurance, Amicus Therapeutics about important…
INTERPHEX Live!: Formulation And Delivery Of Biologics And Complex Small Molecule Compounds
INTERPHEX, in conjunction with Pharmaceutical Processing, presents INTERPHEX Live! During this INTERPHEX Live! video conference Russ Somma, Ph.D., President of SommaTech LLC, an affiliated consulting company of IPS, interviews Kevin Bittorf, Ph.D., Vice President-CMC, In-Licensing & Contracting, Trek Therapeutics; Magali Hickey, Ph.D., Senior Director Pharmaceutical, Chemical & Formulation Development at Alkermes; and Jeffrey Shumway, Associate Director, Business Development, Formulation &…
MG America: Partnership For Success 30 Years And Counting
Founded in 1988, MG America, a subsidiary of Bologna, Italy-based MG2, operates from a 20,000-square-foot facility located in Fairfield, NJ. The company supplies European-crafted processing, packaging, inspection, and material handling equipment to leading pharmaceutical, nutritional, OTC, and medical device companies throughout the United States, Canada, and Puerto Rico. MG America, from its New Jersey headquarters,…
Form Follows Experience In Bioprocess Design
When American architect Louis Sullivan famously proclaimed that “form should follow function” in 1896, I’m sure he had no idea of how this statement would impact the world of design and architecture forever. Sullivan was referencing his idea that a building should serve a greater purpose. Ultimately that purpose should dictate how the building should…
Global Growth Opportunities From A Regulatory Perspective
As regulatory conditions internationally become more consistent and more predictable—thanks to harmonization initiatives—it’s important to consider the relative administrative demands and the business potential in the strategically important markets of Benelux, the Baltics, South Africa, and Canada. ____________________________________________________________________ The barriers to doing business in additional geographical markets are being reduced all the time, not least as…
Looking Ahead: Pharma Outpacing All In 2018 And Beyond
The pharmaceuticals sector is forecasted to grow faster than any other market in the next five years, according to the 2017 State of the Industry U.S. Packaging Machinery Report from PMMI, The Association for Packaging and Processing Technologies. The report analyzes 28 packaging machinery categories and describes trends and the outlook for packaging machinery shipments…
Integrating Siloed Systems: Making The Most Of Automation
In 2016, ROI for the top 12 pharmaceutical companies fell to just 3.7 percent. This sobering statistic is due to both declining pharmaceutical productivity (fewer drug approvals) and increasing research and development (R&D) costs. As the industry looks to the future, it is clear that it needs to consider how to offer the maximum value…
Metadata: The Key To Understanding Your Data
In April 2016, the FDA released a draft guidance titled: “Data Integrity and Compliance with cGMP Guidance for Industry.” In this draft guidance, the FDA clarified much of the confusion and misunderstanding around 21 CFR Part 11 and how data should be addressed, maintained, included/excluded from critical path decisions, and several other key elements to the…
SKAN US Inc.: Serving North America With New Technologies
SKAN US Inc., a wholly owned subsidiary of SKAN AG and a provider of isolation and hydrogen peroxide decontamination technologies, was originally founded in 2006 as a Colorado-based company. In 2012 SKAN US moved and consolidated all sales and service operations in Raleigh, NC. The company’s Raleigh facility is located near the Research Triangle Park area. The facility provides sales/service support, parts…