Newsletter | October 17, 2024

10.17.24 -- BIOSECURE Act Passes House. How Will It Impact Your Outsourcing?

SPONSOR

Mammalian Biologics CDMO Services To Bring Your Program To The Next Stage

Benefit from our tech transfer program along the product lifecycle, and 
de-risk your clinical and commercial manufacturing. You can leverage our CMC expertise, process and analytical development, fitting and optimization capabilities. Ask our team about our Manufacturing Risk Assessment and
get started today!

FEATURED EDITORIAL

BIOSECURE Act Passes House. How Will It Impact Your Outsourcing?

The U.S. House of Representatives was hell-bent on sending a message
to China – and all of us in the biopharma industry. Congress hopes that message – and real-life consequences – will be accomplished via its successful passing of the BIOSECURE Act in a House vote.

Wish SUS Cost Less? Survey Says Your Peers Do, Too

BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.

INDUSTRY INSIGHTS

Mastering Critical Binding Reagents In Immunoassays

Binding reagents play a critical role in immunoassays. Learn how reagent selection, generation, and characterization can enhance assay precision, consistency, and reliability.

Embrace A Contract Manufacturer Partnership That Drives Sustainability

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

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.

Designing An Optimal APAC Clinical Supply Chain

Gain the knowledge and skills needed to effectively navigate the complex clinical supply distribution landscape within this important and rapidly growing region.

Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

Navigating Challenges In Biologics Process Development And Characterization

Delve into the key obstacles encountered in biologics process development, including the complexities of optimizing production processes, ensuring product consistency, and maintaining quality control.

Advancements In Microbial Manufacturing Of Biopharmaceuticals

Review the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

Successfully Producing Insoluble Proteins Using Inclusion Bodies

Compare the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

High Power Mixing At Large Scale: The Xcellerex Magnetic Mixer System

Consider the advantages of 2000 and 3000 L single-use mixing systems and experimental results demonstrating their capacity to deliver high power at large scales and flexibility for use at lower volumes.

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

Uncover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

SPONSOR

Partner Week is back this October! From 10/21 through 10/25, hear from CDMOs across Fill/Finish, Large Molecule, Small Molecule, Cell & Gene, and our newest addition: ADC. Bring your questions and requirements, skip the small talk, and get right down to the business of finding the best-fit partner for your short- and longer-term drug development needs. Register for free at this link.

SOLUTIONS

Container Closure Integrity Testing

Lonza’s Drug Product Services delivers a holistic approach to DP development that prevents problems early and produces a product that is fit for purpose.

Drug Product Fill And Finish

See how comprehensive drug product fill and finish services streamline the journey from formulation development to commercialization, ensuring quality, efficiency, and compliance at every stage.

Raising The Bar On Microbial Expression And Manufacturability

KBI uses an early optimization workflow to ensure manufacturing success. As a result, more molecules are manufactured using an E. Coli expression system than ever before.

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential

This brochure explains how our parallel development service works seamlessly with our existing antibody capabilities, helping to accelerate your ADC program and reach the market faster.

Drug Characterization And Release Testing Services

Leveraging the expertise and flexibility of a partner empowers you to ensure regulatory compliance from the outset, with thorough characterization starting at the earliest stages.

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: