Newsletter | March 24, 2023

03.24.23 -- Draft FDA Labeling Guidance Proposes More Clarity For Providers
 
New Podcast Episode
Featured Editorial
Draft FDA Labeling Guidance Proposes More Clarity For Providers
 
By Alexander K. Aust, MS, MBA, Aust Business Solutions

The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape. 
So, You’ve Been Put On Clinical Hold…
 

As the frequency of clinical holds increases, so do the chances it’ll happen to you. What’s a biopharma leader to do if it happens? Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. offer advice on direct engagement with the FDA to expedite the release of a clinical hold.
Industry Insights
How To Minimize Supply Chain Disruptions In Biopharma
Article | By Paul Priebe, Qosina Corporation

Read how medical device, pharmaceutical, or single-use system manufacturers can manage short-term interruptions to the supply chain without shutting down production.
Batch Quality Prediction
Case Study | Seeq Corporation

A large molecule pharmaceutical manufacturer was struggling to predict batch quality results in near real time. The solution created a better way to predict batch quality and enabling process optimization.
Establishing A Robust Workflow To Identify High-Performing Clones
Application Note | By Sheffali Dash, Michelle Sabourin, Jichu Li, and Paula Ravnikar, Cytiva

Cell line development is a complex, labor intensive, and multistep process. Learn about a platform and host cell line that minimize the risk and timeline to develop high-performing clones.
Overcome Complex Protein Challenges With Optimized Expression
Article | Lonza

Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.
Five Dangers Of An Insecure API Supply Chain
Article | By Ken Ball, Pfizer CentreOne

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.
Solutions
ArmorFlex Powder Mixer Brochure
ILC Dover
Clonal Imager With Automated Assurance
Advanced Instruments, Inc.
Meet The Applications Team
Purolite, An Ecolab Company
Project Farma Cell Therapy Facility Build Planning
Project Farma
Life Science Leader Magazine
 

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.