Newsletter | May 1, 2025

05.01.25 -- Biopharma Under Pressure: Tariff Strategies, Hiring Trends, Logistic Solutions

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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.

FEATURED EDITORIAL

Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers

The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

Talent Logistics Turns Biotech Winter To Hiring Spring

After our "Biotech Winter" – a period starting circa 2021 with tens of thousands of layoffs and stagnating investment — is it springtime for biotech? Chris Frew, Founder/CEO of BioBuzz Networks, says yes. “We have demonstrably entered a turning point in biotech hiring.”

INDUSTRY INSIGHTS

How The Tariffs Could Impact Your Drug Development Supply Chain

Explore how a fully integrated, U.S.-based supply chain strategy can help you navigate potential tariff risks, reduce complexity, and strengthen resilience in pharmaceutical development.

Addressing Key Challenges Of High Concentration Formulation Development

High concentration formulations often present challenges with regard to viscosity as well as potential changes in the behavior upon stability. Discover solutions to mitigate high viscosity.

Characterizing The Effector Functions Of Therapeutic Antibodies

Gain a thorough understanding of the Fc region of your antibody product and how to use a risk-based approach to strategically test its functionality, optimize safety, efficacy, and development.

The Problem With Construction Quality

Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

How Fast-Track Strategies Accelerate Time-To-Clinic

Biopharmaceutical sponsors can minimize to-clinic timelines by using innovative development strategies that trade potentially increased risk for time savings.

Improved Analytical Methods For Traditional And Unique Modalities

Here, we review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.

Single-Use Manufacturing Systems: Implementation Considerations

As single-use systems continue to evolve, more biopharma companies will be able to benefit from their ever-improving reliability and unique adaptability as part of both fully single-use and hybrid processes. 

Manufacture To Control: Considerations In CMC For Antibody-Drug Conjugates

The complex nature of ADCs necessitates meticulous attention to CMC. Gain valuable insights for navigating CMC development, ensuring the delivery of safe and efficacious biopharmaceutical products.

Challenges In ADC Production — Consolidating Operations Under One Roof

By having ADC development and manufacturing under one roof, we streamline processes, enhance safety, and accelerate delivery of high-quality, clinically-ready ADCs.

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SOLUTIONS

BD Pharmaceutical Services And Solutions

No matter where your team is in the process of combination product development, uncover how BD can help to reach your goals quickly and successfully.

Kundl Facility Overview

Learn more about the capacity of our new facility and how our highly automated cGMP capabilities can help produce your innovative therapeutic and reach patients in need.

Aseptic Fill Finish

Our comprehensive inspection systems, designed to adhere to the strictest regulatory standards, offer robust quality assurance, safeguarding the integrity of your product from development through to market.

Pionyr: Selecting A CDMO To Scale-Up Manufacturing

Pionyr Immunotherapeutics, a biotech with a pipeline of first-in-class clinical-stage cancer immunotherapies, needed a CDMO to help rapidly develop a third lead candidate from the start.

Drug Product Development And Manufacturing Services

Backed by trusted data and deep scientific expertise, learn how our adaptive approach ensures seamless progression from preclinical development to commercial manufacturing.

Small, Simple-To-Use Package For Delivering High-Viscosity Formulations

ArQ - Bios offers a small, simple to use package to deliver high viscosity formulations, delivering greater volumes than 1 ml subject to matching the formulation characteristics with acceptable patient tolerability.

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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