Event

Visit Texcell North America at BPI WEST

Will you be attending BPI West this year? We would love to see you !

Visit Texcell-North America at Booth # 223.

Description from the BPI West website:

BioProcess International US West | Bioprocessing Conference (informaconnect.com)

The speakers on our scientific agenda represent the top scientists from leading biopharmaceutical companies around the world.  Learn novel insights from recent case studies and new data presentations designed to accelerate speed and lower costs across all phases of bioprocessing.

Included in the speaker line up, is our CEO of the North American site, Dr. Alysia Birkholz https://www.linkedin.com/in/alysiabirkholz/.

Presentation

Securing Advanced Therapies: Viral Safety Measures, Guidelines, and Personal Perspectives

Ensuring the safety of advanced therapy medicinal products (ATMPs) involves a thorough assessment of potential threats from adventitious agents or viruses. Unit operations focus on virus removal or inactivation, utilizing chromatography, nanofiltration/virus filtration, and various chemical treatments for gene therapies. Process evaluation studies systematically assess virus inactivation during scaled-down steps, quantifying efficacy through log reduction values.


Traditionally, safety assessments for biotherapeutics adhere to globally influential guidelines like ICH Q5A R2/revision 2. This revised Viral Safety document addresses therapeutics, stressing the need for viral testing at early development stages. Alysia Birkholz, a biotech leader and patient, shares a compelling narrative emphasizing the criticality of safety testing. Her story serves as a powerful call to action within the scientific community, aligning with the revised ICH guidelines and advocating for proactive viral safety measures in manufacturing processes. This narrative highlights the imperative of safeguarding patients, especially those with rare diseases, and encourages an early and vigilant approach to ensure the safety of advanced therapies.

Cell and Gene Therapy Manufacturing
 9:00am – 9:30am

PT (Pacific Time, GMT-08:00)

Improve the speed, lower the cost and increase the quality/safety of biologics development

The BPI US West 2024 scientific agenda covers today’s latest innovations across all phases of biopharmaceutical development and manufacturing.

Accelerate Development of Next Generation Biologics

Our Cell Line Development & Engineering track shows you how to perfect your Next Generation hard-to-express biologics through engineering, utilizing the latest technologies and expression systems.

Enhance Product Titer and Quality

Our Cell Culture track shows how industry experts are implementing modeling, ML, AI, automation and PAT to optimize quality, control, productivity and efficiency in upstream processing

Improve Speed and Efficiency During Downstream Process Development

Our Recovery & Purification track shows you how to apply transformative technologies to overcome bottlenecks, maximize quality and control, improve development timelines and enable next generation downstream processing for emerging modalities.

Increase Manufacturing Efficiency Through Smart and Data-Driven Bioprocessing

Our Manufacturing Strategy & Bioprocessing 4.0 track helps you enhance your manufacturing practices for a diverse portfolio of molecules by achieving scalable, green digital processes for in-house and external manufacturing programs.

Accelerate the Development and Production of Novel Cell and Gene Therapies

Our Cell & Gene Therapy track covers today’s ground-breaking bioprocessing, manufacturing, supply chain and analytical strategies to increase efficiencies in the scale up of your cell, gene & gene edited ex vivo cell therapy programs.

Improve the Safety, Efficacy & Reach of Your Novel CAR Modalities

Our Next Generation CAR & T Cell Therapies track covers today’s revolutionary cell and gene engineering techniques to overcome persistence, durability, and solid tumor hurdles – improving applications, outcomes, and patient safety in oncology and beyond.

 

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