Monday, August 21, 2023 Daily Archives

Accelerate Upstream Process Development With Data-Driven Feeding Strategy Optimization

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This webcast features: Chris Schultz, PhD, Team Leader, Centre for Process Innovation, National Biologics Manufacturing Centre. Accelerated timelines and cost reduction are critical in today’s bioprocessing environment, but it is imperative to ensure product quality is unaffected by process modifications. At-line and on-line technologies that inform bioprocess parameters and cell-feeding strategies are needed to develop processes that deliver high-quality products while reducing manufacturing costs. At the Centre for Process Innovation (CPI), bioprocessing experts work with partners across diverse markets in…

August 21, 2023

BioProcess Insider Interview: Min Park, Chief Business Officer, Aton Biotech

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Moderator: Millie Nelson, Editor, BioProcess Insider. Featuring: Min Park, Chief Business Officer, Aton Biotech. In an industry with no shortage of contract development and manufacturing organizations (CDMOs), it is vital to stand out and create unique value for customers. Aton Biotech branched off from its parent company, Henlius Biotech, in 2022 and has hit the ground running by focusing less on building excess biomanufacturing capacity and more on providing CDMO services with expertise in chemistry, manufacturing, and controls (CMC) and…

August 21, 2023

How Emerging Technology Is Improving the Cell Therapy Manufacturing Landscape

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Mercedes Segura Gally, Vice President of Process Development, ElevateBio. Mercedes Segura Gally introduced the audience to ElevateBio, gave a short overview of the state-of-the-field in cell therapies, and discussed key drivers for innovation in the cell therapy space. She highlighted current manufacturing tools and upcoming technical innovations. ElevateBio is based in the Waltham, MA, area. It was founded in 2017 to develop technologies to advance cell and gene therapy products, including offering the chemistry, manufacturing, and controls (CMC) infrastructure to…

August 21, 2023

Advancing Data Driven Drug Discovery

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Letian Kuai, head of WuXi Biology, WuXi AppTec. Kuai introduced his organization’s strong biology department, with 3,000 scientists in nine sites, on three continents. They address end-to-end, service solutions from early discovery to preclinical candidate (PCC) and R&D, with a platform comprising early discovery, lead optimization, and in vivo pharmacology. A center of excellence supports oncology, immunology, and new modalities, including oligonucleotide therapeutics. Kuai focused his presentation on WuXi AppTec’s early discovery platform, to which the team brings a combined…

August 21, 2023

Continuous Manufacturing for Better Access: A Paradigm Shift in Biologics

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Christelle Dagoneau, senior vice president, global biologics business development, Just–Evotec Biologics. Christelle Dagoneau began by explaining Evotec’s focus on evolutionary technology. The company seeks out innovative and disruptive technologies and assembles teams to support integrated discovery, development, clinical, and commercial programs. The aim is to make decisions at the start of development that will increase clinical success rates. Evotec is headquartered in Hamburg, Germany, with 17 sites across the globe, mainly in Europe and the United States. With a diversified…

August 21, 2023

Enabling and Accelerating Innovative- and Emerging- Modalities Drug Discovery Through a Global Open Platform

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Tao Guo, senior vice president, head of WuXi Chemistry, WuXi AppTec. In his Wednesday afternoon presentation, Tao Guo shared information about WuXi AppTec’s global open platform to support drug discovery. He focused on three aspects of the platform: targeted protein degraders (TPDs), targeted covalent inhibitors, and nucleic-acid therapeutics. TPDs are receiving increased attention. Guo noted the use of E3 ligases and protein binders to leverage proteasome clearance mechanisms and thereby degrade target proteins. Two mechanisms are to use proteolysis-targeting chimera…

August 21, 2023

Advances in Protein A Chromatography Resins

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Aaron Moulin, field application scientist, Purolite (North America). Aaron Moulin spoke about Purolite’s patented jetting technology, highlighting the performance of Praesto Jetted A50 and Praesto Jetted A50 HipH protein A affinity resins. He began by describing the traditional way to produce agarose beads through batch emulsification, which takes six to eight weeks. Manufacturers perform solubilization, emulsification (with a nonpolar atrophic solvent, usually toluene), crosslinking, screening (sieving), functionalizing, and final testing for quality attributes. The sieving step alone takes three to…

August 21, 2023

The Secrets of Ensuring a Successful Process Validation Campaign at a CDMO

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Pramthesh Patel, vice president of process development, Avid Bioservices. Process validation is a critical step in the path to commercialization and is fraught with complexities. After offering how Avid, a contract development and manufacturing organization (CDMO), works with its partners, Pramthesh Patel offered three case studies of successful projects. Avid is a dedicated CDMO with over 30 years of experience manufacturing biopharmaceuticals. It is a drug-substance company for both clinical-trial and commercial materials, with batch scales from 100 L to…

August 21, 2023

One-Stop, Integrated Viral-Vector Platform for Speed to Clinic

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Carey Connelly, senior director, process development, Catalent. Carey Connelly works at Catalent’s Maryland gene therapy site in the University of Maryland’s BioPark location, which houses a center of excellence for process and analytical development. She spoke about the company’s integrated viral-vector platform to enhance speed to clinic. After introducing the company as a global and diversified contract development and manufacturing organization (CDMO), she focused on the biologics segment, now referred to as the biomodalities segment, encompassing cell, gene, protein, and…

August 21, 2023

Build it Right: A Quality Perspective on the Design and Build of a Viral Vector CDMO Manufacturing Facility

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Chris Berger, executive director of quality, viral vectors at Avid Bioservices. Avid Bioservices is a contract development and manufacturing organization (CDMO) offering process development (PD) and good manufacturing practice (GMP) manufacturing for mammalian proteins and viral vectors. Berger addressed how important it is for builders of advanced-therapy manufacturing facilities to define a project’s scope, stakeholders, and requirements along with programming the space, managing risk, and ensuring performance. Such preparation determines whether a facility will manufacture only drug substance or also…

August 21, 2023