Newsletter | February 27, 2025

02.27.25 -- How Do We Categorize CDMOs?

SPONSOR

Webinar: The Analytical Journey of a Biologic Drug: From Discovery Through Commercialization

Join this live webinar to learn about the journey of a biologic drug from pre-clinical to commercial release. SGS’s experts will share their extensive knowledge of testing required and ways to overcome challenges encountered throughout the various stages of the drug development process. Click here to learn more.

FEATURED EDITORIAL

How Do We Categorize CDMOs?

Are we on the same page? Do we need to be? That is, how do we differ on what might seem like the mundane defining of CDMOs as small, medium, or large? Some readers have been asking. There are obvious characteristics. First, though, how might this determination be relative and important to individual sponsors? Our Advisory Board members weigh in.

ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them

Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.

INDUSTRY INSIGHTS

Analytical Services: Risk Management In PFS Components Selection

Choosing the right containers and materials is critical. Two risk-based test methodologies help to select the optimum closure materials and correct syringe silicone level at the early phase of drug development.

A Lean, Agile Business Model To Deliver High-Quality Oncologic Treatments

No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart from the others.

Establishing Commercial Manufacturing Services For ADCs

Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.

3 Key Trends Shaping The CDMO Industry

It is essential for biopharma companies to stay up to date on the future of CDMOs. Read about three key trends that are helping shape the CDMO industry.

Optimized Processes: A Guide To Lyophilization Cycle Development

Review the essential phases of the lyophilization cycle—freezing, primary drying, and secondary drying—and critical success factors to achieve optimal product quality and stability.

Client Sustainability Directives — CDMO Perspectives

Gain a deeper understanding of current directives and metrics to equip your team with the knowledge necessary to navigate the evolving landscape of sustainability.

Secure Tech Transfers Of Biological Products In Sterile Manufacturing

Recognizing what it takes to complete technology transfers effectively and efficiently is crucial to selecting the best partner for your project and product needs.

Simulated Control Strategy For Product Diversion Management

Consider this manufacturing platform integrating perfusion bioreactors, continuous product capture, low pH viral inactivation, polishing, viral filtration, and formulation steps.

A Hybrid Approach For Optimizing Transient Protein Expression In CHO Cells

When choosing between protein expression formats such as transient versus stable pools, considerations include speed, cost, titre, and product quality.

SOLUTIONS

Flexible Filling Capabilities For Rigorous Demands

Equipped with advanced robotics, our automated fill line is specially designed to maximize product yield while minimizing the risks associated with operator intervention.

Injectable Drug Manufacturing

From the production floor to the shipping door, your unique clinical or commercial requirements will be fulfilled at each step of the process.

SUREmAb — Monoclonal Antibody Development, The Way It's Meant To Be

Leverage robust development strategies and enable an optimized process for mAb development and manufacturing, efficiency and speed with exceptional quality, and high titers.

Plant 5 — Dream Plant: Within Your Reach. Built For Your Success.

As pressure to accelerate timelines mounts, finding a CDMO committed to increasing capacity and optimizing processes with innovative technologies is key for adding efficiency.

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: