05.16.22 -- Single-Use Bioprocessing Bottleneck

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.

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

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.

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.

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

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.

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.

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.

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.

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

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

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

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.

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.

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.