August 2018 Featured Report

Thinking Outside the Bag: Single-Use Technology Can Drive Innovation at the Benchtop Scale

Cristy Botens, product manager in bioprocessing, Distek Innovation is important, Botens began, and the focus should be on patients. Every innovation means that medicine gets to patients faster or has fewer side-effects. Recent pharmaceutical innovations include the first new Lupus treatment approved in 50 years, a gene therapy cure for inherited blindness, gene therapies for rare diseases, new chimeric antigen receptors on T cells (CAR-T) clinical trials (over 180 trials now), personalized cell therapy, and a vaccine that prevents cervical…

It’s All About Speed: Getting to Early Development Clinical Trials Quickly

David J. Kenyon, senior director of global scientific and technical affairs, Patheon (Thermo Fisher Scientific) Kenyon has over 25 years of experience in the pharmaceutical/biotechnology and vaccine industries. He began his career with Johnson and Johnson, where he managed the production of the first monoclonal antibody (MAb) approved for human therapy. He joined Patheon in 2014. Kenyon received his PhD from the Rutgers School of Medicine and Dentistry of New Jersey. Patheon is now part of Thermo Fisher Scientific. Thermo…

Using New Technologies to Compress Timelines, Increase Capacity, and Reduce Costs: Speed — Why, When, and How

Moderator Tom Ransohoff, with Jorg Thommes, Chris Love, Rajesh Beri, and Geoffrey Hodge For biopharmaceuticals to mature as a process industry, companies need to embrace the ability to adopt new technologies and bring new operational approaches to their biomanufacturing facilities. In this roundtable about adopting and implementing new technologies in the biologics industry, moderator Tom Ransohoff stressed the importance of understanding drivers for adopting new technologies and of developing enabling processes that factor in associated risks and challenges. He offered…

Capacity Strategies: The Strategies Behind Choosing Between Large-Scale and Single-Use Investments

Moderator Dan Stanton, with Weichang Zhou, Jenifer Wheat, Roger Lias, and Jim Vogel Single-use technologies (SUTs) are now prevalent within bioprocessing, but does this spell the end of industry’s historic reliance on stainless steel and fixed facilities? This roundtable was formed to discuss the wealth of investment in single-use (SU) equipment and flexible manufacturing solutions by contract development and manufacturing organizations (CDMOs) over the past few years, pitting that against what looks like a resurgence in fixed-cost stainless steel plants…

Emerging Technologies and Strategies to Accelerate Process Development and Time to Market

Gustavo Mahler, president and chief executive officer, AGC Biologics AGC Biologics is one of the largest global biologics contract development and manufacturing organizations (CDMO) specializing in clinical and commercial development of therapeutic proteins. It has developed more than 200 products, both mammalian and microbial, from preclinical to commercial on all scales. The company’s CGMP facilities are located in the United States, Europe, and Japan. AGC Biologics’s technologies and strategies to accelerate time to market include standardized cell-line and cell-bank creation…

Future-Proofing and Understanding Your Molecule with Contemporary Analytics and Formulation Approaches

Greg Adams, senior director of global analytical strategy and development, Fujifilm Diosynth Biotechnologies (FDB) “Proteins have personalities.” Adams began. Their three-dimensional structures and folding patterns influence how each protein will behave. Analytical methods that evaluate a protein’s quality attributes need to be reproducible and robust. Proteins are evaluated through elucidating their amino acid sequences, using molecular informatics and modeling, characterizing three-dimensional structures, and understanding the degree of posttranslational modifications. The resulting knowledge will help you ensure consistency and safeguard methods.…

Bringing Biologic Products to Market Faster By Partnering with a Single Services Provider from Development Through Commercial Supply

Andrew Sandford, vice president of business development, Catalent Biologics Catalent feels strongly about “Patients First.” The core of the company’s mission is to “enhance and improve the lives of your patients.” Bringing a new drug to market is expensive, costing about US$2.6 billion per drug. It takes an average of 12 years from drug discovery to final approval, with only 1 in 5,000 products ultimately approved by the Food and Drug Administration. The expense, risk, and long timelines of drug…

Product Development Through Commercial Production: Guiding Your Biologic from Start to Finish

Eunyoung Yang, team leader and chief development officer of the business development team, Samsung BioLogics Samsung is maximizing customer satisfaction by providing customized, cost-effective, and comprehensive development and manufacturing services. It is the number-four company in the world worth, US$92.3 billion, with 672 offices in 91 countries and employing 512,000 people. Samsung provides electronics (its most well-known business), engineering and construction for heavy industries, financial services, and healthcare support including biologics manufacturing, a medical center, and electronic medical devices. Samsung…

The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility

Sun Ra Bullins, director of manufacturing, Avid Bioservices Avid Bioservices is a dedicated commercial contract development and manufacturing organization (CDMO) with over 13 years of commercial manufacturing experience. It received six CMO leadership awards in 2018. Avid has a new state-of-the-art facility (2016) in Myford, CA, which has been designed for fully disposable manufacturing with up to 2,000-L capacity; and a legacy commercial facility with stainless steel bioreactors up to 1,000 L in Franklin, CA. In designing the Myford facility,…

CMO Fusion: Where Stainless Steel Meets Disposable Technology

Molly McGlaughlin, director of strategy and business development, BioVectra  Jim Stout, director of process science, BioVectra   McGlaughlin introduced BioVectra. The company has been in business for 45 years and is based in Canada. Its a well-established contract development and manufacturing organization (CDMO) and fine-chemical manufacturer, and is a subsidiary of Mallinckrodt Pharmaceuticals. BioVectra started out as diagnostic reagent company and now has a complementary set of niche capabilities. From 10 years of fermentation experience, it was a logical progression to…