Newsletter | May 16, 2022

05.16.22 -- Single-Use Bioprocessing Bottleneck

Featured Editorial
Industry Insights
Finding The Right CDMO Partner For Tech Transfer

Engaging a partner with the expertise and protocols for a comprehensive tech transfer is key to mitigating risks, such as unsatisfactory yields, unforeseen materials shortages, or unoptimized batch sizes.

8 Misconceptions On Collaborating To Benefit Your Drug Program

Review a few misconceptions about collaborating with Pfizer CentreOne and how they align with the values of courage, excellence, equity, and joy.

Have CDMO Selection Criteria Changed Over The Past Five Years?

Industry Standard Research shares how CDMO selection criteria have changed over the past five years and links the attributes to Life Science Leader’s CDMO Leadership Awards categories. This information can be used by biopharma companies to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

What Big CROs Don’t Want You To Know About Staffing Scalability For Phase 3 Studies

Don’t settle for recycled employees poached from other studies when therapeutically aligned, passionate, and accountable personnel — eager to work on your specific study — are available.

"Validation" Or "Qualification": What’s The Difference?

What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in the manufacturing of cell and gene therapies, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these lifesaving drugs.

Why Is An Integrated Service Offering So Important For The Modern Pharmaceutical Industry?

For small biopharma businesses, it is nearly impossible to manage every aspect of the development process in-house. Outsourcing provides the flexibility to change capacity and adjust timings.

Making The Medicine Go Down: Specialized Delivery Technologies
While most oral solid formulations are designed to release the drug immediately after swallowing, some products have been developed to provide a controlled release of the drug products.
Analytical Quality By Design Using Design Of Experiments
Design of experiment (DoE) is the centerpiece of analytical quality by design. A DoE assay development pipeline approach delivers optimized, robust, and rugged analytical methods ready for method qualification.
Establishing A Resilient cGMP Chemical Supply Chain

The entirety of your supply chain should be considered before building resilience into your workflow. Review the most important considerations to make.

Assessing End-To-End Drug Development Partnerships

As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.

Overcoming Limitations To Achieve Uniform Dosing

An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

Mitigate Risk Of Failure In Biotherapeutic Development

In silico and in vitro protein design and optimization tools help mitigate manufacturing, development, and immunogenicity risks to reduce attrition and improve the quality and safety of therapeutic proteins.

Saving Development Time With A Single-Vendor Approach

Hear a customer’s perspective on how working with a global network integrated by a dedicated program manager can help you accelerate the drug development process and reach the market sooner.

Build vs. Buy: When To Outsource Protein Biologics Development And Manufacturing

Learn the elements and market factors impacting the make/build vs. buy decision, considerations to examine when evaluating options, and best practices for navigating this decision.

Outsourced Pharma Live
Biopharma CEOs And CDMOs: How Involved Should They Be?

Should CEOs be wading in the outsourcing weeds — involved in not only the strategy, but the day-to-day management and activities at CDMO partners? In March 2022, Outsourced Pharma Live hosted three experienced CEOs who shared their experience, outlook, and advice that can help you no matter your position within the outsourcing development and supply chain at your organization.