Newsletter | February 8, 2024

02.08.24 -- Novo Acquires Catalent, Shakes Up Outsourcing World

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With today’s global focus on vaccine development, the need for excellence in clinical cold chain distribution and storage has never been more acute. It is crucial that your chosen provider has the capacity, capabilities, flexibility, and oversight necessary to safely get your clinical vaccine products where they need to go. Learn more about the questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.

FEATURED EDITORIAL

Novo Acquires Catalent, Shakes Up Outsourcing World

News of Novo Holdings acquiring Catalent, and Novo Nordisk taking in 3 Catalent fill-finish facilities, shakes up the outsourcing industry at a time when so many biopharma sponsors for already starved for capacity. Here's breaking analysis from chief editor Louis Garguilo.

Vaccine Manufacture From The U.K. To Brazil And Saudi Arabia

Why is Professor Thomas Rademacher’s U.K.-based vaccine-creating biotech so important that Saudi Arabia has based the establishment of the Kingdom’s first vaccine manufacturing facility on the company? The narrative starts in Brazil.

Is The FDA’s COVID-19 Container Closure System Guidance Useful Post-Pandemic?

The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.

INDUSTRY INSIGHTS

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

Learn how a stage-gate approach to technology transfer and biomanufacturing can help to mitigate risk while shortening cycle times throughout the project life cycle.

Scale Your Process Directly From 3 L To 2,000 L

Innovative solutions allow you to conceptualize and implement accelerated paths to compress processes while minimizing risk and ensuring product quality.

High-Throughput Developability Assessment Enables Efficient Formulation

The biopharmaceutical industry is focused on maximizing the effectiveness of early-stage candidate assessments to predict a molecule’s chances of success before investing heavily in that molecule.

Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

Assessing crystallinity is crucial as 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.

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.

Delivering On-Time, Every Time: 4 Key Factors For Evaluating A CDMO

Review four key factors for improving on-time delivery when outsourcing drug product manufacturing and discover how investing in building a solid relationship with your CDMO improves timelines.

SOLUTIONS

Large Molecule Biologics Made With Intelligent Collaboration

Over the years we’ve learned invaluable lessons in the development of biologics and share our project management experience to support our customers’ drug strategies.

Leveraging An Innovative Conjugation Technology For Better ADCs

Learn how an advanced conjugation technology can provide a more uniform DAR profile, enhanced linker stability, and improved pharmacokinetic properties, paving the way for more efficacious ADCs.

CDMO Services For Vaccines, Gene Therapeutics, And Oncolytic Viruses

We offer biologics contract manufacturing using state-of-the-art technologies to develop and manufacture clinical trial materials for viral vaccines, gene and immune therapeutics, oncolytic viruses, and recombinant proteins.

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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