Newsletter | October 21, 2024

10.21.24 -- BIOSECURE Act Starts Dismantling WuXi

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FEATURED EDITORIAL

BIOSECURE Act Starts Dismantling WuXi

Components of the WuXi global organization are for sale. It’s a forced divestiture. WuXi AppTec is marketing some of its U.S. and European operations. The ill-advised BIOSECURE Act targeting several China-based biopharma companies is having its intended effects, even before the legislation is fully passed by the U.S. government. Where do you stand?

Your CDMO's Maintenance, From Roof To Floor And Ever More

Facility Maintenance – an all-encompassing descriptor. It starts with taking care of an internal ecosphere – everything from roof to floor. It also includes an exosphere – the real estate the facilities sit on, the business parks where they are located, and the communities they reside within. When you are outsourcing, it makes you a part of it all as well. How much do you know about this area of your CDMO’s existence?

Survey Says Downstream Biomanufacturing Bottleneck Is Over

BioPlan's 21st annual survey reveals that downstream processing capacity constraints are at their lowest levels reported in years.

INDUSTRY INSIGHTS

3 Key Considerations When Choosing A Partner For Your Tech Transfer

One way to streamline tech transfer is to partner with a CMO demonstrating a proven track record across the entire drug development and manufacturing continuum.

Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

De-Risking Development With Analytical Characterization Capabilities

Review the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver tomorrow’s medicines safely and efficiently.

Overcoming Challenges: Optimize And De-Risk Your mRNA Product Manufacture

mRNA therapy and vaccine manufacturing can be complex when working with multiple CMOs. Partnering with an end-to-end CMO is essential for overcoming these challenges.

Demonstrating Value Throughout The Product Development Lifecycle

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

An Inside Look At CMC Strategy Development For Novel Biologic Formats

Understand an integrated drug substance and product CMC strategy for novel molecular formats and recombinant proteins, offering tailored solutions that accelerate entry into the clinic.

Reducing ADC Timelines With Integrated Development And Manufacturing Services

ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.

The Stage-Gate Model: A Proven Approach To Streamline Biomanufacturing

Uncover how a Stage-Gate approach to technology transfer and biomanufacturing can help to mitigate risk while shortening cycle times throughout the project lifecycle.

Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

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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

Mechanistic Chromatography Modeling To Accelerate Process Development

Discover mechanistic chromatography modeling software designed for smarter and faster process development that inputs lab data and creates models from which you can perform in silico experiments.

Flexible End-To-End CDMO Solutions

Consider how your CDMO can adapt and implement processes within their clinical manufacturing facility, as this directly translates to enhanced speed and flexibility in your overall manufacturing operations.

Microbial Expertise

We’re proud to be pioneers in the microbial field, with a track record of success going back to the 1980s and our work on recombinant interferons.

Developability Assessment

Set your drug candidates up for success with our early developability assessments to identify optimal therapeutic antibodies and minimize late-stage failure risks.

Transport Simulation Laboratory

Identify vulnerabilities early in development and implement preventative measures against distribution-related damage with our Transport Simulation Laboratory (TSL).

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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