Newsletter | May 7, 2025

05.07.25 -- Peptides, Packaging & People: Biotech's Biggest Shifts

SPONSOR

Webinar: Utilizing a Stepwise Approach for Nitrosamine Risk Mitigation

Mandatory nitrosamine testing has driven stricter standards for drug development. Join Cambrex's Todd Sprouse as he shares a stepwise, product-specific approach to detect, quantify, and control nitrosamine impurities efficiently. Key topics include risk evaluation, formation feasibility, analytical method development, and mitigation through targeted testing of materials. Click here to learn more.

INDUSTRY INSIGHTS

Improve Speed To Market By Mitigating Vial And Stopper Incompatibility

These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.

The Write Side Of AI: Augmenting Capabilities, Not Replacing Them

AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

Covalent Drugs – Advantages, Challenges, And Opportunities

By understanding covalent therapeutics’ inherent challenges and providing insight into how difficulties can be overcome, Aragen empowers its partners to seize opportunities in this rapidly expanding field.

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.

'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.

INDUSTRY INSIGHTS CONTINUED

Powering Drug Development With Advanced AI Retrosynthetic Analysis Tools

Review advanced retrosynthetic analysis services and how these tools empower better, more efficient development of innovative small molecule drugs.

Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing

Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

The High Potent Market And The Role Of A Specialist CDMO

Safe handling of HPAPIs is complex and the associated regulatory requirements are growing. Discover how leveraging a CDMO can ensure treatments reach patients faster, safely, and cost-effectively.

Advancing Patient-Centric Drug Delivery With Orally Dissolving Tablets

Pharmaceutical companies must prioritize patient-centric dosage forms to address challenges like dysphagia, enhance medication compliance, and improve therapeutic outcomes.

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Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

SOLUTIONS

A CDMO With Oral Solid Dose And Sterile Injectable Expertise

No matter the scope of your project, we deliver — streamlining product formulation and manufacturing from concept to clinic to commercial scale.

Blister Solutions Designed To Accommodate Your Needs

With over 6,000 tooling parts and an in-house machining center to ensure precision, explore this versatile blister service that provides both Thermoformed and Cold-Formed solutions.

Oral Solid Dose Manufacturing

At Alcami, we provide cGMP manufacturing services that scale with your development and approval milestones, ensuring a seamless transition from clinical to commercial supply.

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.

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