Newsletter | July 15, 2024

07.15.24 -- Select Your CDMO Based On How You Operate

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With over 35 years’ experience in the medtech, diagnostics, and pharmaceutical markets, SMC Ltd. provides in-house engineering, injection molding, assembly, fill finish, device manufacturing, packaging services, and can manage sterilization. Our customers rely on us for speed-to-market and our program management process is a key to well managed projects. With inhouse global supply chain expertise, we help customers reduce risk while maintaining tight timeframes. Learn how we can excel your next project.

FEATURED EDITORIAL

Select Your CDMO Based On How You Operate

“We tell them up front we will be hands on. That's a good way to pick the right partners. In other words, we select and view our CDMOs based on the way we operate," explains BlueSphere Bio CEO Keir Loiacono. With a background as an attorney, it's an interesting outsourcing operations indeed.

The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing

This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.

Speeding Up The Regulatory Side Of Outsourcing

Benjamin Stevens, Director CMC Policy and Advocacy at GSK provides some initial thoughts on the regulatory aspects related to moving programs to and through the clinic as quickly as possible.

INDUSTRY INSIGHTS

4 Questions To Ask Your Fill Finish Partner To Minimize Risk And Maximize Yield

Reducing risk while maximizing API volume is critical during the fill finish phase of manufacturing. To ensure safety and quality, partner with an experienced fill finish provider.

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 lifecycle.

Specializing In Small And Early-Stage Partners, Not Just Small Batches

Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

Secondary Packaging Strategies For Commercial Launch Of A Biologic

A commercial packaging solution can be the first and enduring impression that a sponsor company makes on a patient, and its suitability can impact a biologic’s commercial success.

Improving Efficiency In Upstream Process Development

Uncover the latest trends in cell culture technology, tools and enablers for scale-up, strategies to accelerate CLD, media development, raw material characterization, and more.

Optimizing The Path To First-In-Human Clinical Trials: Design And De-Risk

Explore the ways to design and de-risk molecules, streamlining the path to GMP manufacturing and clinical trials, and case studies that provide insight into key activities.

Understanding The Microfluidic Platforms For Scaling Nanoparticle Production

Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.

Streamline Microbial Process Development To Reach Toxicology Trials Faster

For biopharmas looking to outsource their early phase development, consider working with a CDMO partner that has the knowledge and experience to navigate microbial fermentation and complex process development.

Modeling And Online Estimation Of kLa And P/V

Explore continuous models of kLa and P/V in 250mL and 5L bioreactors in order to scale-up and compare bioreactor performance metrics.

SOLUTIONS

Testing Solutions For Biosimilars

Our scientists offer insights into physicochemical and structural properties, including post-translational modifications, through a range of assays.

Cleanroom Collaboration

Learn how INCOG BioPharma's speed and flexibility can help your organization with your drug product, from clinical to commercial, with our high-performing cleanroom facility and filling technology.

High-Speed Filling Line For Vials

Examine how a new high-speed aseptic filling line can help bring your product to market with speed and efficiency while ensuring safety and high product quality.

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: