Author Archives: BPI Staff

TESSA Platform Delivers High-Quality, High-Titer, Multiserotype rAAV Stocks

Presented by: Maria Patr√≠cio, lead scientist for viral design and discovery, Oxgene, a WuXi Advanced Therapies company Building upon colleague Jason King‚Äôs BPI Theater presentation on transient transfection platforms for viral-vector production, Patr√≠cio focused on scalable manufacturing solutions for adenoassociated virus (AAV), the vector used most often to deliver gene therapies. AAV naturally requires a helper virus to replicate. Plasmid transfection enables helper-free manufacture, but that process is difficult to manage at commercial scales. A more scalable approach is to…

Applying the Allogeneic Process to Overcome Challenges in Cell Therapy

Presented by: Evan Zynda, staff scientist, Thermo Fisher Scientific Cell therapy companies increasingly are pursuing allogeneic therapies to negotiate manufacturing challenges associated with autologous approaches. Products based on high-quality cells from healthy donors could improve therapeutic efficacy. Allogeneic approaches also could facilitate large-scale therapy production, which in turn could reduce time-to-treatment and increase therapy affordability and accessibility. Zynda showed how increased understanding of T-cell biology could help improve allogeneic workflows. Zynda emphasized the utility of studying signaling pathways associated with…

Transient Viral Vector Solution

Presented by: Jason King, business development manager, Oxgene, a WuXi Advanced Therapies company Since joining the WuXi Advanced Therapies division of WuXi AppTec in March 2021, Oxgene has focused on helping gene therapy developers to optimize their viralvector production systems as they transition from preclinical and early clinical projects to good manufacturing practice (GMP)-grade manufacturing. King observed that early stages of gene therapy development nearly always involve systems for transient transfection rather than scalable platforms. Inducible producer cell lines, viral…

Enabling Pharma and Biotech Innovation Through an Open-Access Platform: Targeted Protein Degradation

Presented by: Dave Madge, vice president, research division, WuXi AppTec Madge described methods that his company applies to identify and evaluate bifunctional molecules that mediate targeted protein degradation (TPD). He pointed out that although much TPD research focuses on proteolysis targeting chimera (PROTAC) compounds, the tools used to identify such molecules also can be used to evaluate the therapeutic potential of other bifunctional molecules. Of particular interest are those that bring ‚Äúhousekeeping proteins‚ÄĚ to disease-causing targets. More broadly, researchers are…

BioProcess Insider Interview: Sam Machour, Samsung Biologics

BioProcess Insider brings the biotechnology news as it breaks. For the on-demand BPI Theater at the Biotechnology Innovation Organization‚Äôs 2021 convention, founding editor Dan Stanton interviewed leading biopharmaceutical executives in early June 2021. Contract development and manufacturing organizations (CDMOs) have thrived during the COVID-19 pandemic despite constraints on supply chains. Sam Machour, senior vice president and chief quality officer at Samsung Biologics explained that his company‚Äôs pandemic-period success has stemmed primarily from its ability to accelerate production timelines. Before 2020,…

BioProcess Insider Interview – Marc Hummersone, Astrea Bioseparations

BioProcess Insider brings the biotechnology news as it breaks. For the on-demand BPI Theater at the Biotechnology Innovation Organization‚Äôs 2021 convention, founding editor Dan Stanton interviewed leading biopharmaceutical executives in early June 2021. Highlighting the rapid proliferation of cell and gene therapies (CGTs), Hummerson described how his company seeks to support downstream processing for emerging therapies. Hummerson reflected that when he joined the biopharmaceutical industry in 2006, developers of monoclonal antibodies (MAbs) expressed great need for innovative purification solutions. The…

CGMP Manufacturing Facility Design and Evolution

Presented by: Mike Alston, Jr., director, project engineering; and William Leonardi, PhD, senior project manager, Avid Bioservices These two speakers shared lessons learned in the design and buildout of current good manufacturing practice (CGMP) manufacturing facilities at Avid. Leonardi began with a history of the company‚Äôs 28+ years of biologics development and manufacturing and its track record as a successful contract and development manufacturing organization (CDMO). Avid‚Äôs main campus comprises a cluster of buildings in Tustin, CA. GMP, process-development, and…

Exothera selects Pall for suspension-based manufacturing contract

Pall will equip Exothera‚Äôs expanded facilities in Belgium with a suspension-based manufacturing platform of up to 2,000 L to support the CDMO‚Äôs viral vector ambitions. Contract development and manufacturing organization (CDMO) Exothera was launched in March 2020 by Belgium-based bioprocess tech firm Univercells, to offer cell and gene therapy developers process development and viral vector manufacturing. The firm is expanding its two facilities in Jumet, about 25 km south of Brussels, and has selected bioprocess vendor Pall Corporation to equip…

Sepragen skids to help Serum Institute ramp up vaccine production

Sepragen has delivered two chromatography skids to the Serum Institute of India to help increase monthly production of COVID-19 vaccines from 40 million to 200 million doses. Bioprocess equipment manufacturer Sepragen Corporation recently shipped out two 125 liters/minute QuantaSep chromatography skids, with integrated inline buffer blending capabilities, to the Serum Institute, located in Pune, India. ‚ÄúThese skids will allow the vaccine manufacturer to increase their production from 40 million doses per month to 200 million doses per month,‚ÄĚ a Sepragen…

Technologies and Innovations: A Discussion with Selexis SA

Pierre-Alain Girod is chief scientific officer (CSO) for Selexis SA. He holds a PhD in plant biochemistry from the University of Lausanne in Switzerland and completed a postdoctoral fellowship at the University of Wisconsin in Madison, WI, on the degradation of proteins by the ubiquitin pathway. Girod returned to Switzerland in 1993, where he discovered a family of sequences that are involved in the epigenetic regulation of genes. That discovery subsequently has been used to express therapeutic proteins in the…