May 2017 – From the Editor

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The first half of 2017 has been leading us to next issue’s focus on the state of the industry. Although we are not officially calling it our “15th anniversary issue,” that of course is what prompts our focus on progress and future projections. By the time you read this, that issue will be on its way to the printer. So here are my thanks, in advance, to those of you who took time with our related survey. We editors look forward to sharing the results, following up with interviews, and including your comments.

As usual, though, we do try to rock the boat a bit. So the issue is organized around “functional groups” rather than our traditional process divisions. Assuming that the old “silo” mentality truly is fading, we’re emphasizing interconnections across groups based on advances in automation, single-use systems, contract services, analytical sophistication, regulatory harmonization, and industry globalization — among other topics. This plan is open to interpretation, but here’s how we see those groups, allowing for crossover among many functions across different phases of drug development:

Corporate/Executive/Business: contract research, development, manufacturing, testing, and marketing/sales; investment/financing; product sales and marketing

Engineering: facilities, single-use technologies; upstream and downstream process engineering, optimization

Laboratory Management: analytical methods and instrumentation, GLP/GMP laboratory regulatory compliance, data acquisition and management software

Logistics/Cold Chain: process intermediates, container– closures, product/sample containment, storage and shipping

Process Development: upstream production and downstream processing (drug substance manufacturing), single-use technologies, process optimization/control

Production/Manufacturing: drug-product manufacturing, delivery methods, formulation fill and finish, container– closures), single-use technologies, combination products

Project Management: contract research, development, and manufacturing; product development

QA/QC–Analytical: analytical methods and instrumentation; product/process characterization, validation, qualification; formulation; stability testing, toxicology/immunogenicity testing; raw materials testing

Regulatory Affairs: GLP/GMP/GCP compliance; INDs, BLAs, and regulatory dossiers; biosimilars, emerging therapies; clinical testing

Research and Development: drug discovery, product modalities (e.g., proteins, gene/cell therapies, vaccines, etc.), developability assessments; clinical testing

Technology Transfer/IT: data management, enterprise resource planning (ERP), and control software; automation, process analytical technology (PAT), 21 CFR 11 compliance.

At this fall’s BioProcess International conference (part of KNect365’s larger Biotech Week Boston program), we will offer a number of panels in the BioProcess Theater for functional-group representatives to talk about issues identified in our survey. If you want to participate, just let me and/or publisher Brian Caine know.

As the spring and summer conference season continues, I wish you all safe travels and successful networking. Please think of BPI when you hear a presentation that you think could become a useful article for us. We editors cannot get to all the events that we’d like to cover, so we welcome your guidance as we move into our next 15 years.

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