Newsletter | March 13, 2025

03.13.25 -- How To Build Resilience Amid Dynamic Biopharma Vendor Relationships

SPONSOR

Webinar: Rapid Delivery of Toxicological Study Material: The new critical path for accelerating biopharmaceutical drug development.

With ever increasing speed from DNA to IND, the window for toxicological data generation is becoming shorter and more critical. In this webinar we explore the key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material. Click here to learn more.

INDUSTRY INSIGHTS

Analyzing The Need For An Engineering Run: A Risk-Based Decision

Executing or skipping an engineering run is a consequential decision for any biopharma or CDMO and should be supported by all available data as well as a thorough risk assessment.

Scaling Up: Increasing Production Capacity While Reducing Costs

Medical device companies must meet the demand plan for their devices while managing production costs. Gain valuable insights for scaling up production capabilities efficiently and cost-effectively.

Mastering QbD: Process Validation Campaigns, Commercial Manufacturing

In this presentation, industry-leading bioprocess experts explore the challenges and opportunities that arise when implementing Quality by Design (QbD) in biologics development and manufacturing.

A 5-Factor Framework For Successful CMO Partnership

Identifying manufacturing capacity that can adapt to a growing and changing biopharma landscape requires an emphasis on technical and operational expertise combined with agility and flexibility.

Tips For Successfully Scaling From R&D To Manufacturing

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Leveraging Transposase Technologies To Optimize Cell Line Development

Enable a wide array of genomic manipulation with the more regulated and efficient genomic insertion that's made possible by transposase-based technologies.

A Flexible Approach To CMC For Fab And Fc-Fusion Development Programs

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

Why The Right Partnerships Are Key To Streamlined Drug Development

Explore several strategies for selecting the ideal CDMO partner for your pharmaceutical project, helping you navigate the evolving drug development landscape and drive successful outcomes.

How Platform Technologies Power Up Processes From Lab To cGMP

This expert Q&A examines ways to push the envelope of expression system technology and process characterization while maximizing user transparency.

FEATURED EDITORIAL

How To Build Resilience Amid Dynamic Biopharma Vendor Relationships

The key to effective vendor management lies in understanding how relationships derail in the first place. Here are some common reasons and tips on how to avoid them.

Every CDMO Seems Ideal Until The Project Begins

Jin-an Jiao, VP of Process and Analytical Development at Synthekine, has worked with CDMOs worldwide. "When starting a new project, everyone seems perfect," he says. "Everybody's great." But that can change fast, highlighting the need to confirm a real commitment to timelines.

SOLUTIONS

Process Robustness And Consistency In Biologics Manufacturing

Our multi-product manufacturing facilities feature state-of-the-art equipment for animal cell-derived viral and microbial products for your clinical trials in phase 1-2 and in accordance with cGMP guidelines.

Commercial/Clinical cGMP Quality Control Analysis

With well-equipped, on-site analytical and microbiological laboratories as well as stability chambers, our scientists monitor end-to-end processes to confirm the safety and quality of each batch.

A Global Team United By One Shared Passion

United by a passion for innovation, our global team delivers life-changing products with expertise and process excellence, partnering with top pharmaceutical companies worldwide.

Advancing Your Molecule With Speed And Agility

We offer a comprehensive suite of bioanalytical and spatial biology solutions designed to support the progression of your molecule from discovery through clinical development and product approval.

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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