Newsletter | June 5, 2025

06.05.25 -- Lean Thinking For Pharma — Flow Without Facility Upheaval

FEATURED EDITORIAL

Lean Thinking For Pharma — Flow Without Facility Upheaval

By Irwin Hirsh, Q-Specialists AB

Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

By John W.M. Claud and Michelle L. Butler, Hyman, Phelps & McNamara

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

Using Virtual Reality To Enhance Aseptic Contamination Control

By Subrata Chakraborty, Ph.D., INOPHAR Consulting & Training and Ajay Pazhayattil, Ph.D., cGMPWorld

Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.

8 Ways To Drive Resilience In Oncology Drug Supply Chains

By Kerim Ozbilge, EY

From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

INDUSTRY INSIGHTS

The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly

Article | Cytiva

In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

Helpful Biosafety Testing Innovations Where And When You Need Them

Article | MilliporeSigma

Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

SOLUTIONS

Streamline Your mRNA Purification Steps

MilliporeSigma

Protein A Resin With High Binding Capacity

Cytiva