Author Archives: BPI Staff

In brief: Vetter opens clinical filling site in Austria

Vetter has received manufacturing authorization for a fill and finish site Austria, which the CDMO acquired in 2020. Contract development and manufacturing organization (CDMO) Vetter bought the clinical production site in Rankweil, on the Austrian border with Switzerland and Liechenstein, from Impletio – part of Rentschler, with which Vetter inked an alliance in July 2020. The firm has been working to modify and equip all laboratory, technical and production areas at the 10,000 square-meter facility and has announced this week…

WACKER’s plug-and-play technology serves growing pDNA demand for cell and gene therapy

The global demand for nucleic acid-based gene therapies, novel vaccines and innovative therapeutic agents, including messenger RNA (mRNA) and viral vectors, is extremely high and projected to increase in the future. Plasmid DNA (pDNA) is the basis for all of these advanced therapies. Plasmid DNA can be used either directly for vaccines and gene therapies, or as starting material, e.g., to manufacture mRNA. The CDMO market for pDNA is expected to grow by 19 percent by 2025 (Global Viral Vector…

Univercells adds DNA synthesis through SynHelix buy

Univercells has entered the synthetic biology space through the acquisition of French DNA synthesis firm SynHelix. The deal, financials of which have not been disclosed, sees Belgian bioprocess firm Univercells add technology aimed at simplifying biotherapeutic development through a scalable and automated DNA synthesis platform. SynHelix’s technology is based on the GMP production of long DNA fragments in large quantities and has been touted as an alternative to DNA amplification on bacteria in the synthetic biology, gene therapy, and diagnostics…

What’s new in AAV manufacturing? 3 takeaways from Thermo Fisher Scientific

From virtual regulatory inspections to optimization of scalable AAV production, the gene and cell therapy fields continued to innovate and evolve throughout the pandemic. Thermo Fisher Scientific hosted an interactive workshop highlighting some of these developments, including a new AAV production system, a custom media platform for viral production cell lines, and changes to the regulatory process. Read on to get a taste of those insights. A Helper-Free AAV Production System Adeno-associated viruses (AAVs) are among the most promising gene…

Increasing productivity in cell and gene therapy bioprocessing with fast and reliable immunoassays

Cell and gene therapy manufacturers need to ensure the safe delivery of their products and rely on fast and reliable immunoassay platforms to do so. This white paper gives an overview of the viral vector landscape and the requirements for immunoassays in viral vector bioprocessing analytical workflow. It also shares case studies from viral vector labs that are using the Gyrolab technology to deliver fast and reliable results. Increasing productivity in cell and gene therapy bioprocessing with fast and reliable…

Hot off the Press: Quality by Design for AAV manufacture

Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest obstacles when moving towards regulatory approval and presents a significant risk to the success of new gene therapy drug candidates today. A key aspect to the CMC documentation of such complex biological products is the application of the Quality by Design (QbD) principle: A rationale of quality being achieved by process design rather than relying on final quality testing alone. The work presented here provides a framework…

BioProcess Insider State of the Industry — September 2021 Panel Discussion

Our BioProcess Insider editorial team sits down with Joshua Speidel, PhD Partner, Latham Biopharm Group, Patrick Lucy, President and CEO, Lykan Biosciences, and Amélie Boulais, Head of Market Entry Strategy, Virus Based Therapeutics at Sartorius, to reflect on how the quarterly movements of the wider pharma industry are affecting the biomanufacturing space. Through the analysis of global events, recent deal making, and regulatory and technological advancements, we look to determine the factors driving or squeezing production and pre-empt upcoming trends…

Advanced Instruments buying cell line dev tech firm Solentim

Advanced Instruments will add antibody and cell-based therapy workflow tech through the acquisition of Solentim. “The coming together of Advanced Instruments’ and Solentim’s core technologies, will be a powerful combination in support of clonal cell line development,” Byron Selman, CEO of Advanced Instruments, said. “With Solentim, we are acquiring innovative technologies that will enhance our ability to support customers in these workflows. We are also adding to our technical capabilities with the addition of imaging, advanced AI capabilities and automation…

Tailoring the Cell Line Development Process to the Specific Molecule and Program Goals

Presented by: Gregory Bleck, PhD, vice president, Catalent Biologics Speed and efficiency remain major drivers for developers bringing their protein-based biologics to first-in-human studies. The right cell-line development approach can help streamline a path to clinic for both standard monoclonal antibodies and more complex modalities such as bispecifics. Bleck shared recent data on how the GPEx suite of technologies provides for high titers, short timelines, and flexibility in cell-line development for mammalian-expressed proteins. He began by explaining that protein therapeutics can…