Articles

• Pharma Manufacturing on the Move

  Global supply needs are dictating facility locations and CMO selection.

• cGMPs and Statistics

  FDA’s Rick Friedman and Karthik Iyer explain why some manufacturers need to get a better grip on GMP-related statistics.

• Biomanufacturing Shows Signs of Maturity, PAT Adoption

  Manufacturers are reporting fewer batch failures, adopting PAT and other quality initiatives, and stepping up supply chain quality control.

• Biopharma's Flexible Imperative

  Business forces, bioterror and pandemic risks demand new approaches to manufacturing.

• Manufacturing Strategies for Biosimilars

  Regulators have paved the way for low-cost biologics, but it’s up to manufacturers to select the right technologies and define quality.

• Afnan: Biopharm: Thinking Too Linearly?

  The idea that “the product is the process and the process is the product” can either result in sameness, or true control.

• Memories of Our Masthead: Julie Cappelletti-Lange

  A tribute to our dear friend and colleague, Julie Cappelletti-Lange.

• From the Editor: Inspiration and Innovation

  The yin is just as important as the yang; sometimes, even more so.

• PharmaView: The Future? Let's Get Pumped Up

  To survive, Steven Burrill tells Big Pharma, ignore the “gravel in the road” and embrace the disruption.

• Are You Using A Sledgehammer to Monitor Temperature and Humidity?

  Facilities often use complex and time-consuming tools to accomplish what should be a simple task.

• Sourcing Solutions for Environmental Monitoring: Ask the Right Questions

  Accurate answers to the wrong questions pose risks and unnecessarily drive up costs.