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By Jason Starkey, Michael Adler, and Pankaj Paranjpe

It has become cliché to begin articles and research papers with dazzling statistics and revenue projections from the demonstrated and potential promise that biotherapeutics, vaccines, and cell therapy provide. Indeed these projections could be the beacon of the Era of Biologics, with biologics as the front and leading class of therapeutics that provide great value to the industry and hope for the patients we strive to serve. And like all clichés, those dazzling numbers do provide some truth!

When we speak of biologics as a class of pharmaceuticals, this includes many modalities, including peptides, proteins, glycoconjugate vaccines, and cell-based therapies to name a few. Such a wide spectrum of compounds are often manufactured using cell-based expression systems and processes that can be quite complex. The understanding and control of such manufacturing processes is central to enabling fast delivery of the latest therapies to the patients. To meet this objective and market demand, various topics within biomanufacturing are common themes across the industry: speed to the clinic and market (efficiency, batch cycle times, etc.), robustness of processes to mitigate variability (of raw materials, process parameters, etc.), and the integration of analytical tools to provide process insight (in process control and real time release).

ICH Q8(R2) embodies the general principals of pharmaceutical development and emphasizes the importance of using a risk-based approach in aiding correlation of material attributes and process parameters with critical quality attributes and defining control strategy. Process analytical technology (PAT) has the potential to enable deep process insights and possibly a future where real-time parametric release may be possible for drug products and drug substances. Single-use technologies promise cutting back the turnaround times for batches and reduction in cleaning validation requirements among other advantages.

These seemingly disparate topics (focusing primarily on drug product aspects) drive home the criticality of an integrated pharmaceutical development strategy for manufacturing and process development of biologics for the future.

At the upcoming 2015 AAPS National Biotechnology Conference, June 8–10 in San Francisco, we are presenting a unique opportunity to take audience participation to the next level! For the roundtable discussion session Best Practice in Biomanufacturing, we are seeking questions from you to help us design the session based on the most relevant and critical themes.

The following themes will be addressed:

  1. Process risk assessment and control strategies
  2. PAT solutions—in line and at line and latest developments
  3. Application of single use technologies in biologics drug product manufacturing processes

This is how it will work:

  • Send us questions, comments, and quandaries related to these three broad areas by emailing them to biomanufacturing.roundtable@gmail.com by May 15, 2015.
  • We will collate the received questions, categorize them, pick the most popular ones, and design our session using those themes.
  • We will have a great session in San Francisco, learn new things, get some benchmarking information, and most likely generate new questions (psst… for next year’s conference!)
Michael Adler, Ph.D., is a pharmacist holding a doctorate in pharmaceutical technology. In his current position as head of Late-Stage Pharmaceutical and Processing Development at Roche, he and his team are responsible for market formulation, process development, technology transfer, and process validation of both biological drug products and small molecule parenterals.
Pankaj Paranjpe, Ph.D., is in the Biologics/Drug Product Development group at Celgene, where he is involved in pharmaceutical development and tech transfer to manufacturing sites for early to late stage molecules. He is the current chair of the AAPS Sterile Products Focus Group.
Jason Starkey, Ph.D., is a senior principal scientist and group leader in the Biotherapeutics Pharmaceutical Sciences Analytical Research and Development group at Pfizer. His role is to support the development and analytical strategy for early and late stage mAb, ADC, and vaccine programs; he is also involved with the development and integration of PAT related technologies in clinical manufacturing.