Newsletter | January 4, 2024

01.04.24 -- Gliding Towards De-Risked Combination Product Development

SPONSOR

2024 PDA Annual Meeting

The 2024 PDA Annual Meeting promises to be nothing short of epic! Get ready for plenary speakers who will ignite your imagination, technical presentations, and high-energy roundtable discussions to keep you at the top of the industry, and networking opportunities to connect you with the best minds in pharma! Top that off with industry site visits and fun and engaging social activities! Register now.

FEATURED EDITORIAL

Pacesetters: Innovators Who Embrace Digital Process Enhancement

The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.

A Brief Introduction To Environmental Monitoring For Startups

Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.

INDUSTRY INSIGHTS

Gliding Toward De-Risked Combination Product Development

Discover how a new product’s role is critical in determining combination products’ exposure to extractables and leachables.

Regulatory Considerations For Alternative Microbial Methods

We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

NEWS HEADLINES

Biocon Biologics Partners With Sandoz For The Distribution Of ‘Adalimumab BS Subcutaneous Injection [FKB]’ In Japan

Coherus Announces FDA Approval Of UDENYCA ONBODY, A Novel And Proprietary State-Of-The-Art Delivery System For pegfilgrastim-cbqv

Formycon Announces EMA Acceptance Of The MAA For FYB203, A Biosimilar Candidate To Eylea (Aflibercept)

SOLUTIONS

Factors Which Impact mAb Process Scale-Up