Newsletter | November 5, 2024

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

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A Full-Service Solution Partner Disrupting the Outsourcing Paradigm

inSeption Group offers a full-service solution designed to disrupt the current outsourcing paradigm, resurrecting a common-sense approach to rebuild business trust and confidence in a client’s selected vendor. Primarily focused on oncology, hematology, neurodegenerative disorders, and rare/orphan disease indications, with a specialization in cell and gene therapy, inSeption has been a solution for its' clients who have experienced the progressive degradation of today's outsourcing options. Contact them.

FEATURED EDITORIAL

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?

Selecting And Managing CDMOs For Novel Therapies

Verve Therapeutics' Praveen Prasanna, Ph.D., GenSight Biologics' Scott Jeffers, and University of Minnesota's Vaibhav Patel explore the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies.

The Key Questions Of Strategy For Outsourcing

Chief Editor Louis Garguilo starts off our Outsourced Pharma Live with the key questions to ask about the strategic direction of your drug development and manufacturing outsourcing.

INDUSTRY INSIGHTS

Analytical Comparability Of 5 Alternative AAV9 Downstream Processes

Explore how two-column AAV processes can enhance yield and potency while maintaining high-quality standards in the production of gene therapy products.

Biotech Banter: The Realities Of Manufacturing

Experts discuss automated processes, “platformization,” moving early-stage companies into a commercialization structure, and how to support the academics developing these processes.

From Crisis To Confidence In Medical Writing: Ensuring Smooth Submissions

In this presentation, we examine some of the major challenges that medical writing submission specialists face today and present strategies that can consistently set the stage for success.

Advancing CAR T-Cell Therapies With Clinical Trial Customization

Discover how to optimize your CAR T-cell therapy clinical trials with expert insights on genomics, flow cytometry, biomarkers, and clinical operations.

Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing

Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.

Exploring The Cost Considerations Of Immune Cell Therapies

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

mRNA/saRNA Manufacturing RNA Program Development And Support

Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations for process development.

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.

Make More Lentivirus And Make It Right The First Time

Achieve higher titers and robust yield with an optimized, end-to-end lentivirus platform, designed to maximize production and quality for the success of your cell or gene therapy.

From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

Review the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

Optimizing Viability And Standardization For Clinical Excellence

Witness how IntegriCell delivers high-quality, manufacture-ready cryopreserved leukopaks, vital for consistent and reliable cell therapy production.

SOLUTIONS

Phase-Appropriate, Tailored Process Development Support

In cell and gene therapies, your process is the product. Our team of experts develops, defines, and refines processes for maximum efficiency and scale.

Cellistic Capacity Update July 2024: Cell & Gene Therapy

Gain insights into the current challenges in the cell therapy space and discover how Cellistic addresses these issues with iPSC technology, emphasizing regulatory strategies and advanced capabilities.

Adeno-Associated Virus (AAV) Vector Lot Release Package

Our lot release package for the Adeno-Associated Virus (AAV) Vector covers various assays to determine vector-specific characteristics, the presence of adventitious agents, and residuals.

Partnering With You From Preclinical Through Commercial Scale

Work with us from start to finish of your product or partner with us at any stage of your project — preclinical through commercial scale.

RNA Therapies

One Team, One Roof, One CDMO

ReciBioPharm’s expanded biologics services and technologies encompass the entire RNA development and manufacturing value chain, helping to deliver your innovation to patients seamlessly.

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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