BPI Theater

How Are Service Companies Responding to the Increased Interest in New Modalities, and What Regulatory and Market Hurdles Still Exist?

Moderator Dan Stanton, with Juan Cordova (Abzena), Dawn Ecker (BDO), and Scott Miller (Carbogen Amcis AG) Moderator Dan Stanton led the second roundtable discussion at the BPI Theater at CPhI, which focused on emerging therapies and specifically how service companies are responding to the increased interest in developing new modalities. More Monoclonal Antibodies In Ecker’s presentation earlier that afternoon, her data had suggested that monoclonal antibodies (MAbs) have not yet peaked. Stanton began by asking the panelists to comment on…

How Has Single-Use Increased Access to Biomanufacturing Solutions for Both CDMOs and End-Users?

On Wednesday, May 1, 2019, Dan Stanton moderated a CPhI Theater roundtable discussion focused on single-use technologies’ solutions for the biomanufacturing industry. Panelists Scott Patterson, Vice President of Commercial Sales at ILC Dover, and David Lyon, a senior research fellow Lonza Pharma, explored whether process sponsors and manufacturers will continue to prefer consumables to stainless steel equipment and how that preference might create new markets and therapies. Watch the full roundtable discussion below and leave your thoughts or questions on…

Bioconjugation CMC: Successfully Executing a Complex Process

Scott A. Miller, senior scientific advisor, Carbogen Amcis AG Miller provided an overview of bioconjugation followed by a brief discussion of the project management aspects of this highly complex process. Developing and manufacturing antibody–drug conjufgtes (ADCs) is complicated, so it’s important to understand how to manage the processes involved. Some general considerations for developing ADCs include understanding the current phase of a project, the number and status of analytical methods required, the scale of conjugation, the sourcing of both antibody…

Where Are Today’s Biomanufacturing Bottlenecks and How Is Industry Looking to Overcome Them?

Moderator Dan Stanton, with Ramon LeDoux (YMC Process Technologies), Courtney Morgret (AbbVie), and Kiran Chin (MKA Insights) Moderator Dan Stanton began the discussion by talking about bottlenecks within manufacturing. “The term bottleneck brings up imagery that describes the sort of problems we have when it comes to the manufacturing flow,” he stated. He posed the first question to Kiran Chin: “Your presentation highlighted companies that ask the right questions, and you spoke of the importance of doing so when it…

At What Point in Drug Development Must a Firm Look to Process Optimization, and How Critical is this Timing to a Product’s Overall Success? A Roundtable Discussion

Moderator Dan Stanton, with Kelsey Achenbach (Roquette), Andy Davies (Prometic Bioseparations), and Eric Langer (BioPlan Associates) Dan Stanton initiated the final roundtable of the 2019 BPI Theater at CPhI by asking panelists about process optimization. “Why has it entered the mainstream of parlance within the biopharmaceutical industry?”   Achenbach defined process optimization as anything that improves a process, typically from a cost perspective. The term interests many people in the industry now because it is at a stage where such…

Biopharma as a Maturing Industry: Raw Material Selection as a Means of Process Optimization

Kelsey Achenbach, head of pharmaceuticals marketing, Roquette Roquette is a family-owned French company with more than 20 manufacturing facilities and a presence in more than 100 countries. For small-molecule pharmaceuticals, it offers a broad range of excipients; for large molecules, it offers ingredients both for cell culture and protein stabilization. The company has more than 300 people in its R&D workforce who focus on understanding the science behind their materials. Achenbach’s goal was to initiate a conversation between raw material…

Reducing Risk and Improving Timelines in the Design, Development, and Manufacture of Antibody Drug Conjugates

Juan Cordova, principal scientist in bioconjugation, Abzena Cordova began his presentation by introducing Abzena as a global network that provides an integrated solution for the development and manufacture of biotherapies, including antibody–drug conjugates (ADCs). The company operates three different facilities, in which it develops and manufactures complex small molecules as well as bioconjugate therapies. ADCs are one of the most complex examples of biotherapies approved by the US Food and Drug Administration (FDA) on the market today because they comprise…

China’s Focus on Innovation: Investment in Product and Process Development — Innovative Technologies from China Are Coming

Eric Langer, managing partner, BioPlan Associates China is a probable center of concentration for the next generation of biotechnology. However, Langer believes that the country will fail in its goal of achieving that if it cannot innovate. He said that forecasters need to understand the complex elements associated with development of biotechnology centers other than those for biogenerics and biosimilars. How is China going to develop the necessary innovation capability? Driving the industry are the 7,500 cancer deaths every day…

Flow-Through Polishing and the Use of Multimode Ligand Libraries to Improve Process Efficiencies

Andy Davies, sales and marketing director, Prometic Bioseparations Davies began his presentation with a few words about his company, which for the past 30 years has provided a range of bioseparations products, including off-the-shelf and bespoke solutions. Prometic Bioseparations recently launched a number of semidisposable and disposable, prepacked, GMP-ready columns. The latest launch is a multimode mimetic (MMM) ligand library, which was the focus of his talk. Among a range of technologies, the least resolving technique is gel filtration, which…

Scaling Multi-Column Chromatography to the Production Suite

Ramon LeDoux, senior business development manager, YMC Process Technologies LeDoux focused his presentation on downstream bioprocess techniques, specifically scaling up multicolumn processes. Relatively new advances in twin-column technology have brought significant increases in productivity over the past several years. That led YMC Process Technologies to adopt a twin-column approach. A challenge with traditional chromatography has been to balance purity, throughput, and recovery. “If purity is your standard,” LeDoux stated, then “typically if you want high recoveries, your throughput suffers. Overloading…