Newsletter | December 9, 2024

12.09.24 -- Every CDMO Is Perfect Before The Project Starts

SPONSOR

Webinar: What’s Wrong with My Trial? Uncovering the Root Cause of Clinical Trial Troubles

Clinical trials often face unforeseen challenges that can derail progress and necessitate costly corrective efforts. However, many of these challenges can be avoided with proactive planning and early intervention. Explore the most critical steps companies can take to prevent trials from reaching a point of crisis and the importance of addressing systemic issues before they escalate. Click here to learn more.

FEATURED EDITORIAL

Every CDMO Is Perfect Before The Project Starts

Jin-an Jiao, VP, Process and Analytical Development, Synthekine, has worked with CDMOs around the world. "When you talk with them about starting a new project," he says, "everybody's perfect. Everybody's great.” Unfortunately, that can change quickly, and thus the need to confirm "a real commitment to timelines." Part 3 and our final discussion with Jiao ...

Is Your CDMO's Pricing Acceptable?

Is the price for materials and services your CDMO is presenting you a fair price? How can you determine that? A quick discussion on pricing from an experienced outsourcer.

INDUSTRY INSIGHTS

Mammalian Or Microbial? Considerations When Choosing An Expression System

Discover how whether you’re trying to achieve speed and cost-effectiveness or higher yields and glycosylation capabilities, the right system can be tailored to meet the needs of each unique biologic.

Measuring Filter Performance — It's More Than Just A Label

How is the performance of a filter measured? Learn why the micron rating is an incomplete measure of filter performance, why the beta-ratio is a more accurate indicator, and more.

Deciphering mRNA Immunogenicity: Assessing Human Immune Response

Review strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP, and the protein encoded for by the mRNA.

Automating Cell Based Assays, Reducing Variability And Time To Results

Cell-based assays are challenging due to inherent biological variation in the starting materials. Explore the development of a cell-based potency assay implemented on an automated platform.

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

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.

Critical Success Factors For Cell Line Development

Optimal cell line development is crucial for successfully navigating clinical trials and regulatory processes. Here's what you should know about cell line development to ensure a successful launch.

Overcome Global Medicine Shortages With Innovative Manufacturing

Looking to improve the resilience of your supply chain? Who isn’t? According to a report by Bain & Company, improving supply chain resilience will require redundancy, adaptability, and predictability.

Process Intensification To Improve Efficiency, Productivity

Explore the key principles of process intensification as a strategy for improving the efficiency and productivity of biologics manufacturing, including process modeling, control, and advanced analytics.

CDMO Installs Toploading Packaging Solutions To Meet Small Lot Needs

Gain insight into the toploading packaging solutions Sharp relies on to address the evolving needs of clients for small lot packaging of specialized and personalized drugs.

SOLUTIONS

Capacity Update October 2024: ADC

Streamline your ADC project with the Proveo™ alliance, offering seamless, end-to-end support across antibody production, bioconjugation, and aseptic fill.

Analytical And QC Lab 3D Facility Tour

See how we provide CMC analytical testing support for both cGMP product release testing, as well as product stability programs conducted under cGMP and ICH guidelines.

Capacity Update October 2024: Fill/Finish

Boost production for clinical and commercial drug products using our high-quality GMP manufacturing capabilities, featuring a state-of-the-art isolator-based filling platform and extensive fill-finish capacity.

Capacity Update October 2024: Large Molecule Drug Substance

We have the capabilities, competitive advantages, and capacity to onboard new projects across two facilities: Waltham, MA, operational since 2020, and Vilnius, Lithuania, established in 2004.

Particle Control In Biopharmaceuticals

Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.

Capacity Update October 2024: Fill/Finish

Enhance your injectable projects with our expertise and expanded capacity to meet the demand for vials, pre-filled syringes, and cartridges from pre-clinical development to commercial launch.

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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