Newsletter | August 1, 2024

08.01.24 -- Outsourcing At Cerus: Blood, Sweat … And FTEs?

SPONSOR

Not really into choosing extended time away and exhibit halls over the simple pleasures of summertime? No reason to put your CDMO search on hold – Outsourced Pharma Capacity Update’s PARTNER WEEK is now available on-demand. Take the travel and headache out of your plans and tune in right from your computer. Assess potential fit for your next drug development project in convenient 20-minute segments – all grouped by molecule type. Detailed presentations include current available capacity across featured capabilities. View each session on-demand here.

FEATURED EDITORIAL

Outsourcing At Cerus: Blood, Sweat … and FTEs?

After four decades in the biopharma industry, including at NIH, Elan Pharmaceuticals, and Gilead Sciences, Nils Olsson may be undertaking his most complex role: continue to develop and supply vital technologies and pathogen-reduced blood components to blood centers, hospitals, and patients relying on safe blood supply. 

Does Single-use Seem Daunting? Try Starting With Standard Assemblies

You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

INDUSTRY INSIGHTS

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic has implications for a therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Effective Process Validation Accelerates Your Drug To Market

Discover how building a product development program with a long-term vision and adopting a holistic PPQ and CPV strategy from the outset are now crucial.

5 Areas To Focus Your QRM Strategy For Sterile Drug Products

Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

What Can You Do To Improve Your ADC's Chance Of Clinical Success?

Improving your ADC’s chance of clinical success requires an understanding of what potential obstacles lie ahead and what capabilities and expertise are necessary to overcome them.

Embracing Quality-By-Design For Enhanced Development Strategies

In the biopharmaceutical development world, Quality by Design cuts risk, streamlines processes, and speeds up regulatory approval.

Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics

What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?

Considering The Cost Of Poor Quality

By prioritizing quality, biotech companies can ensure a smoother development process, safeguard patient well-being, and bring life-saving treatments to market faster.

The Key Steps In Analytical Method Development, Qualification, And Validation

Review how following regulatory guidelines and partnering with a reliable contract manufacturer ensures the highest standards are met in pharmaceutical research and quality control.

SPONSOR

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

SOLUTIONS

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.

GS Discovery Transient Expression System

Streamline your journey to market by using the same proven CHO cell line and vectors from discovery through to commercial production.

Extractables And Leachables Services: Health Inspired, Quality Driven

With our top-tier services, reliable expertise, and global network of laboratories, we provide unparalleled support to improve countless lives.

Closing The Gap Between Theory And Therapy

A molecule with great therapeutic potential is only as good as its formulation. For patients, a successful formulation closes the gap between theory and therapy.

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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