Newsletter | September 21, 2022

09.21.22 -- Should You Hire Talent Away From Your CDMOs?

New Podcast Episode
From The Editor
Featured Editorial
Industry Insights
Project Management To Meet Today’s Drug Development Challenges

Gain insights into the steps CDMOs can take to streamline project management to benefit the small and emerging biotech companies they work with.

Process Platforms vs. Custom Process Development For AAVs And Gene Therapies

To address cost, time-to-market, and manufacturing complexity, many developers have turned to turnkey manufacturing platforms. Can these platforms provide the right solution for successful CMC development?

Benefits Of RABS, Isolator Tech In A Changing Regulatory Landscape

Restricted access barrier system or isolator technologies are an integral component of quality control. Understanding the key elements of each ensures the most informed decision for your product.

Infrastructure Investments, Innovation Accelerate Biologics Development

Keeping pace with the market dynamics transforming the biologics space requires a focus on innovation and access to the integrated resources necessary to support it.

Vanderbilt Moves Toward A Paperless Cell Therapy Process

The future of cell-therapy systems is here, so learn the importance of patience when implementing a paperless system today.

Self-Injection Of Biologics Made Easy

Ready-to-use (RTU) 3 mL cartridge-based, single-use pen devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

Taking Biotherapeutic Candidates From Late Discovery To The Clinic

Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other cell line or process issues. 

How To Build A Robust Packaging Strategy For Rapid Commercialization

Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

Taste Masking 101: Optimize Taste And Improve Patient Outcomes

Taste masking is an integral consideration for a drug product’s final formulation. It can serve to increase patient acceptability and adherence to a therapy, in turn bolstering regulatory acceptance and commercial potential.

Technical Considerations For Developing Oral Solids (Part 2)

In the second installment of this series, experts from Pfizer CentreOne’s global network and partner organizations consider the effects of equipment design and different tablet strategies.

Leveraging 505(b)(2): Real-World Evidence Rescues Program

Discover how a biotech company that could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA got the help it needed.

Navigating Analytical Requirements For GMP Viral Vectors

The keys to success are establishing appropriate strategies and fundamental testing, expecting additional regulatory requests, preparing for assay variability, and ensuring comparability study preparation.

10 Questions Investors Ask: And How To Respond To Them

In building your new drug program, investors are betting on you to effectively manage development. Answering their questions well increases the likelihood of receiving support for your company’s vision.

Accelerating The Development Of Oncology Medicines

Oncology drug development has seen a significant shift in focus, as molecule chemistries and drug technologies have improved. Explore five areas for consideration and the potential emerging solutions.

Placing Drug Strategies On A Solid Foundation For Success

Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval?

Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future of uncertainty and disruption.

Risk Mitigation Through Dual Sourcing Strategy

A global biopharmaceutical company with a high-value, highly potent drug product for a rare disease indication approached a CDMO to secure the supply of one of their life-changing commercial drug products.

Innovative Softgel Technologies To Deliver Poorly Soluble Molecules

Learn how to expedite the development pathway for early-phase compounds and how lipid-based formulations provide an innovative approach to enhance bioavailability for challenging molecules.

Nasal Delivery Technology, QbD Processes, And Outsourcing

Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.

Rapid Development Of Amorphous Solid Dispersions For Bioavailability

See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.

Outsourced Pharma Capacity Update

Join us October 4 to 6, 2022, as leading CDMOs in biologics, small molecule, and cell and gene share their capabilities and available capacities via a live, interactive webinar.