Biopharmaceutical companies seeking to move their product candidates into clinical testing as soon as possible face several challenges. Tackling the chemistry, manufacturing, and controls (CMC) section of the investigational new drug (IND) application requires due diligence and a commitment to quality and safety. Efficiency comes into play when speed to IND is the goal. In this featured report, experts in upstream and downstream processing, analytical support, and cell-line development discuss how teams can work together to advance their projects as quickly and cost-effectively as possible without compromising vital criteria.

Introduction: Finding Efficiencies to Accelerate Development of Biologics
Cheryl Scott
BPI’s senior technical editor introduces this report by describing the engineering evolution toward balancing speed to IND, drug quality, and production cost. Consultant commentary adds perspective, and links to past BPI articles help readers delve into more detail.
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The Upstream Perspective: Taking Efficiency Beyond Cell-Line Development
Cheryl Scott, with Yuval Shimoni (Bayer)
An interview with a frequent BPI author and principal specialist in quality assurance at Bayer highlights how single-use technologies and automation can help companies address quality by design (QbD) concerns while streamlining early process development in upstream production. Discussed are hardware and instrumentation, QbD and related approaches, and other “speed to IND” strategies that can take expediting upstream process development beyond just cell-line development.
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The Downstream Perspective: Putting Knowledge to Work with Technological
Innovations

Cheryl Scott, with Margit Holzer (Ulysse Consult)
An interview with a previous BPI author and European consultant focuses on the value of high-throughput screening, process analytical technology, and platform approaches in helping companies develop early purification processes for IND submissions and manufacturing of clinical test materials without compromising product quality, safety, or efficacy along the way. Read on to learn more about membrane adsorbers, modeling and analytics, and monoclonal antibodies (MAbs) as vanguard products for advancing tools and technologies.
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The Analytical Perspective: Turning Data into Information Requires Teamwork
Cheryl Scott, with Claire Davies (Sanofi)
An interview with Sanofi’s head of bioanalytics draws on her experience in development, qualification, and method transfer to internal and external commercial quality control units; characterization, comparability, and developability of proteins and gene therapies; and analytical support for up- and downstream development, production, product release, and stability testing. The interview reveals the importance of teams and technology in rapid analytical development and the increasing importance of “big data” in QbD.
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Get to IND Faster: Accelerated and High-Performance Cell-Line Development
John Gill (Samsung Biologics)
A cell-line development expert at Samsung Biologics highlights chemistry, manufacturing, and controls (CMC) activities needed for realizing speed to IND and describes his company’s three-month process. This sponsored article is based on an April 2020 webinar.
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