January 16, 2015

What Drove Biopharma Development in 2014?


Process Development Forum (PDF) featured a myriad of topics at the forefront of biopharmaceutical development. But some issues stood out as garnering the most attention from readers in 2014. One of them is Quality-by Design (QbD). As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that trend is only expected to rise. According to a 2014 CPhI report, more than 70 percent of pharma manufacturers are looking to increase quality and invest in technologies and techniques like QbD to achieve that goal. And while QbD may be a federal requirement, the technique has emerged as a tangible tool to speed time to market, reduce recalls and rejects, minimize post-approval changes, streamline data flows across the entire life cycle of the drug, and improve overall efficacy and cost-efficacy for patients and manufacturers. So, it is no surprise that half of the top 10 stories read by PDF visitors were related to QbD—from implementation to designing quality experiments.

In addition to developing quality biopharmaceuticals, manufacturers continue to create innovative medicines for treating various diseases, thus driving the trend of next-generation antibody-based therapeutics. To that end, PDF articles and posters related to monoclonal antibodies (mAb) were well received by website visitors. In fact, the monoclonal antibody market represents the fastest growing segment within the biopharmaceutical industry. The global monoclonal antibody market size exceeded $80 billion in 2013, and could reach $141 billion by 2017, according to Paradigm Global Events, an independent business information provider.

PDF readers also saw continued improvements and innovations in bioprocessing equipment and consumables. In 2014, there was significant increased interest in continuous processing, both upstream and downstream. On the PDF site, this trend was evident based on webinar invitations, as well as in published application notes and articles, such as Highly efficient inoculum propagation in perfusion culture using WAVE Bioreactor™ systems.

This year, PDF will continue to report on industry trends that interest our readers. Be sure to look out for our upcoming readership survey where you can identify the topics you’d like to read more about in 2015. In the meantime, check out the top-10 PDF stories in 2014:

Quality by design for biotechnology products—part 1

PDA’s technical report for biotech cleaning validation

Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum

Highly efficient inoculum propagation in perfusion culture using WAVE Bioreactor™ systems

Determining Criticality, Part Two: DoE and Data-Driven Criticality

Quality by design for biotechnology products—part 2

Purification Strategies to Process 5 g/L Titers of Monoclonal Antibodies

New Biopharmaceuticals: A review of new biologic drug approvals over the years, featuring highlights from 2010 and 2011

Implementing DoE techniques for increased output



Tags: QbD, trends, review, 2014