Newsletter | May 24, 2023

05.24.23 -- Decline In Cell And Gene Therapy Outsourcing?

From The Editor
Featured Editorial
Industry Insights
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.

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.

Evolving Solutions To Optimize Clinical Trial Decentralization

The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

How Oral Solid Coating Technologies Can Enhance Delivery Strategy

With increasing molecule complexity posing growing challenges for formulation and manufacture, oral solids specialists require extensive expertise and cross-team collaboration to ensure project success.

Utilizing Expertise And Experience In Downstream Processing

Working with a CDMO that can impart extensive expertise to the numerous methods of downstream drug substance manufacturing ultimately can help you achieve the most positive outcomes for your process.

A Technical Package That Serves On-Time Injectable Project Completion

The accuracy, robustness, and completeness of the technical package an organization submits to its development and/or manufacturing partner is critical to meeting fill project timelines.

Achieving New Heights By Expanding Services, Talent, And Facilities

As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.

Fc-fusion Cell Line Development: Expression And Analytical Solutions

Understand high titer expression of Fc-fusion proteins using the Apollo X platform coupled with integrated quality assessments, enhancing support for clients through the predicted growth in Fc-fusion clinical applications.

Developing Robust mRNA Processes In A cGMP Environment

Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

Exploring The Dynamic Landscape Of Digital Medicines And Digital Therapeutics

Driven by advances in technology and increased acceptance of telehealth, see how digital medicines and DTx are poised to become an integral part of the healthcare model.

Pursuing A “Biologic Revolution” With Vaxxinity’s Mei Mei Hu

In a recent episode of Business of Biotech, Vaxxinity's Mei Mei Hu explored how traditional vaccines and biologic therapies are converging to improve access to treatment on a global scale.

Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies

A number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress toward commercialization of remarkable therapeutics.

Faster Determination Of Dynamic Binding Capacity

Streamline the downstream process using variable pathlength technology to determine the DBC of affinity chromatography resins to produce reliable data more effectively and efficiently.

Global Sterile Manufacturing And Lyophilization Capabilities Of Biologics

The stability challenges of many biologics require lyophilization to improve product stability, increasing the demand for CDMOs with a high level of expertise and scalable development and manufacturing solutions.

Confronting Scalability With Autologous Therapies

Autologous immunotherapies have evolved to provide breakthrough treatments, but complexity of the production process often results in extended timelines and high manufacturing costs.

Revolutionizing How Medicines Are Made, Funded, And Scaled

Hear from site leaders and virtually tour the process and analytical development laboratory and GMP manufacturing facility, which includes four additional 2,000-liter single-use bioreactors.

What’s Your (Molecule) Preference?

Did you know: The Outsourced Pharma newsletter comes in different "flavors?” You can get a small molecule, biologics, or cell and gene therapy focused edition — or a version that covers all three molecules in a single newsletter.

Select the flavor that suits your current outsourcing "tastes" by updating the topic preferences on your profile page.

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.