03.31.22 -- Biopharma Deal-Making In 2022: Key Trends

Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.

When executed properly, hot melt extrusion (HME) advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.

In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?

In this paper we review a unique Protein A column that uses an expanded polytetrafluoroethylene membrane composite that offers high binding capacity at high flow rates.

Levicept founder and CEO Simon Westbrook shares the value a global CDMO partner brought to his virtual company as it develops a complex protein he began working on while at Pfizer.

bluebird bio's Scott Cleve sat down with Business of Biotech to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

Size exclusion chromatography (SEC), also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

The importance of — and requirements for — nonclinical studies and recommendations for putting together a nonclinical program team that optimizes the likelihood of moving candidates into clinical trials.

Scientists are constantly striving to develop the highest producing clones and to do so faster. We now demonstrate how this can be achieved by using only a handful of cloning plates.

Read how the downstream polishing train can be restructured and simplified and chromatographic purity standards met with a reduced number of chromatographic steps.

How a biotech captured quality and yield of chromatography peaks and created the ability to share column integrity, process yield, and quality metrics throughout the organization in near real time.

A global top-ten pharma company sponsored a complex, eight-year Phase 3 trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.

As the industry continues to apply innovative manufacturing tools and solutions, it also needs real-time monitoring to keep up with a modern production suite. 

Explore new options for the prepacked disposable chromatography market from scouting columns through to pilot/process-scale columns and their scalability.