Newsletter | March 19, 2025

03.19.25 -- 'Fractional Hiring' At Your CDMO. Okay With You?

INDUSTRY INSIGHTS

GMP Annex 1 For Sterile Manufacturing In The EU

The revised EU GMP Annex 1 mandates a comprehensive Contamination Control Strategy, continuous environmental monitoring, and species-level contaminant identification to ensure compliance.

Molecular Properties Of PROTACs And The Relationship To Formulation Design

Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.

Diverse Mentorship Models Create Multiple Paths To Employee Success

Since life science professionals hail from diverse backgrounds, educations, and work experiences, different mentorship models serve their varied development needs and learning styles.

Proactive Strategies To Evaluate And Mitigate Clinical Supply Risk

Learn about strategies that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.

Innovative Technology For Developing, Scaling Peptide-Based Therapeutics

Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.

Placing Drug Strategies On A Solid Foundation For Success

Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

De-Risking Early Phase Micronization With Integrated Solid Form Selection

Review a case study describing the selection of the optimal solid form of an API designed for pulmonary administration through the pulmonary route.

FEATURED EDITORIAL

'Fractional Hiring' At Your CDMO. Okay With You?

We need a flexible hiring marketplace – a new ecosystem – to generate increased awareness by professionals and students of positions in the biopharma industry. “It’s no longer about simply posting full-time jobs,” says Chris Frew, Founder/CEO of BioBuzz Networks. But is “fractional hiring” the answer?

Generic Drug Approvals In Canada: Using Foreign-Sourced Reference Products

Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.

SOLUTIONS

Advancing Continuous Flow Chemistry With Next-Gen Reactors

The HANU, a new photo-flow reactor, provides better process control, less risk in hazardous chemistry, less solvent use, and is better for the environment.

Fine Chemical Manufacturing Services: R&D From Concept To Commercial

This portfolio of comprehensive research and development services is equipped to handle all your product development needs and bring your projects from concept to production.

Sterile Drug Product Development And Manufacturing

Consider how our cost-efficient, innovative model can help to support your NCE programs from discovery to commercialization.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

Connect With Outsourced Pharma: