BPI Theater

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

On Tuesday, April 30, 2019, Dan Stanton moderated a CPhI Theater roundtable discussion about the ways that biomanufacturers are confronting great demand for monoclonal antibody (MAb) therapies, antibody drug conjugates (ADCs), and other emerging treatments that depend on complex chemistries. Featuring Juan Cordova (Principal Scientist of Bioconjugation at Abzena), Dawn Ecker (a consultant with the BioProcess Technology Group at BDO), and Scott Miller (Senior Scientific Advisor at Carbogen Amcis AG), this panel explored current challenges to upstream processing for antibody…

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

At the CPhI Theater on Tuesday, 30 April 2019, Scott Miller, Senior Scientific Advisor at Carbogen Amcis AG, explored how sponsors should choose a contract manufacturing organization (CMO) when producing antibody drug conjugates (ADCs). Developing ADCs raises several challenges, from its toxic payload, to its several tedious purification steps, to its exacting analytical requirements. Sharing his experiences as both a process sponsor and a CMO representative, Miller offers a comprehensive sense of the selection process that determines the bioprocess. Fill…

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

Moderator Dan Stanton hosted a panel discussion covering biologics manufacturing bottlenecks on Wednesday, May 1, 2019, at the CPhI Theater. Panelists Ramon LeDoux of YMC Process Technologies, Kiran Chin of MKA Insights, and Courtney Morgret of ABBVIE discussed how bottlenecks are slowing products to market today in the biopharmaceutical industry. Watch the full roundtable discussion below and leave your thoughts or questions on the topic below in the comments.

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?

Moderator Dan Stanton hosted a panel discussion on Wednesday, May 1, 2019, at the CPhI Theater, and started the discussion by asking, “What is process optimization and why has it suddenly entered the mainstream of parlance within the biopharmaceutical industry?” Panelists Kelsey Achenbach of Roquette, Andy Davies of Prometic Bioseparations, and Eric Langer of BioPlan Associates weighed in. The discussion continued on to process improvement, bottlnecks, and single-use manufacturing platforms. Watch the full presentation now. Leave your comments or questions…

Biopharma as a Maturing Industry

Kelly Achenbach, head of marketing for pharmaceuticals at Roquette spoke on Wednesday, May 1, 2019, at the CPhI Theater on the topic of the biopharmaceutical raw materials supply chain. When mature commercial biopharmaceutical manufacturers make a switch in raw materials, problems can arise. Achenbach’s presentation includes a case study and probes how biotherapeutic manufacturers should approach these changes. Just fill out the form below to watch the full presentation.

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

In his talk at the CPhI Theater on Tuesday April, 30, 2019, Juan Cordova, a principal scientist in bioconjugation at Abzena, explained how a single-use membrane absorber can improve the manufacturing of antibody drug conjugates (ADCs). An ADC process usually entails resin-based chromatographic separations that take considerable time, require tedious cleaning, and need validation of packing procedures. Substituting conventional resin-based media with single-use membrane absorbers, Cordova suggests, can expedite the timeline for ADCs’ complex manufacturing process. Fill out the form…

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

Eric Langer, managing partner at BioPlan Associates presented on biopharmaceutical innovation in China on May 1, 2019, at the CPhI Theater. China biomanufacturers can’t rely on biosimilar production alone, as the margins in that industry aren’t high enough to allow the companies to be innovative and compete and develop the next generation of biotherapeutics. But over the last five years, China’s industry has made significant investments in innovation, with overall expenditures on R&D higher than the EU. Just fill out…

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

On May 1, 2019 at the CPhI Theater, Andy Davies, sales and marketing director at Prometic Bioseparations discussed biopharmaceutical separations, and multimode ligands. He shared that there is a trend toward using a very effective capture step — typically using affinity chromatography, where the bulk of purification is done in the initial step. More recently, scientists are beginning to adopt flow-through purification, where the target protein passes through the column, and the contaminants or impurities that still reside in the…

Scaling Multi-Column Chromatography to the Production Suite

Ramon LeDoux from the Bio/Pharma Systems Group of YMC Process Technnologies, Inc., spoke on Wednesday, May 1, 2019, at the CPhI Theater on scaling multicolumn chromatography processes. Relatively new advances in twin column technology have led to significant increases in productivity over the past several years. As a result, YMC Process Technologies has adopted a twin column approach. Just fill out the form below to watch LeDoux’s presentation.