Newsletter | May 13, 2025

05.13.25 -- We Must Rethink The Solvents We Use For Peptide Synthesis

SPONSOR

Webinar: A New Look at Subcutaneous mAb Delivery Using Nanoformed Particles

Subcutaneous (Sub-Q) delivery offers self-administration and fewer hospital visits but is challenging for high-dose biologics. Nanoform developed a concentrated, non-aqueous Sub-Q IgG1 suspension using its patented dry particle platform. The study evaluated particle size impact, formulation properties, protein quality, and stability, with pharmacokinetic studies ongoing. Key topics include Sub-Q benefits, Nanoform’s dry particle process, and non-aqueous suspension formulation. Click here to learn more.

INDUSTRY INSIGHTS

Embrace Quality Risk Management To Build A Strong Quality Culture

Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

4 Conversations To Drive Your Business Case For Digital Validation

Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.

Phase-Appropriate Combo Product Development And Commercialization

Strategic planning for combination products across clinical phases streamlines development, reduces costs, and ensures a smoother transition to commercialization through informed decisions.

Tablet Edge Erosion – Solutions For Friability

Addressing tablet edge erosion and friability involves adjusting formulation, tablet design, tooling, press setup, and operation speed to improve tablet robustness and reduce weight loss.

Project Management: Sphere Of Influence

The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.

Control API Impurities To Achieve Therapeutic Safety And Efficacy

In your CDMO search, prioritize finding a partner who recognizes impurity control as a critical component of patient-focused drug development and offers the necessary capabilities to ensure it.

Corporate Social Responsibility In Equipment Purchasing And Management

Explore how pharmaceutical companies can reduce waste, cut emissions, and improve financial performance by prioritizing equipment reuse and optimizing asset management.

Digital Transformation Optimizes Production, Quality, And Compliance

Discover how advanced automation solutions at Fermion's new facility were implemented to enhance production, quality, and compliance in pharmaceutical manufacturing while meeting industry standards.

Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

Outlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, such as biologics and vaccines, and how SARS-CoV-2 could be fueling an explosive increase in PFS demand.

A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing

Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

Extractables And Leachables: Risk Management And Analytical Solutions

Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

SPONSOR

Webinar: Pharmaceutical Labeling: How To Optimize Labeling In A Pharmaceutical Environment

Accurate and readable pharmaceutical labeling ensures patient safety, effective medication use, and regulatory compliance. In this webinar, you’ll learn how factors like speed, printing methods, and inspection criteria influence the choice of labeling machinery. HERMA, with 40,000+ global installations, specializes in vial, bottle, syringe, autoinjector, carton, and tamper-evident labeling, offering solutions to meet space constraints and automation needs. Click here to learn more.

FEATURED EDITORIAL

We Must Rethink The Solvents We Use For Peptide Synthesis

While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

SOLUTIONS

Interactive Lab Experience For The Pharmaceutical Industry

Pharmaceutical Laminar Flow Equipment For Cleanrooms

Quality, Data, And Analytical Solutions

Advanced Product Inspection Technologies For Pharma And Biopharma

API Stability Combined With Rapid Disintegration

Integrated Biotech Services: From Strain To Commercial Product

Connect With Pharmaceutical Online: