Wednesday, May 25, 2022 Daily Archives

Moving Beyond PEI: Improved Transfection Processes for AAV and LV Manufacture

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GMP-compliant nucleic acid delivery to HEK 293 cells is often a critical first step in the manufacture of advanced therapies, utilizing recombinant adeno-associated virus (AAV) or lentivirus (LV) to facilitate delivery of a therapeutic transgene to patients. Accordingly, the need for safe and reproducible large-scale viral vector manufacture processes has never been greater. Mirus Bio has developed a fully synthetic, innovative transfection formulation to enable higher titer AAV and LV generation and reduce the cost of therapeutic development and manufacture…

May 25, 2022

Hanmi makes move into the mRNA CDMO space

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Hanmi Fine Chemical says the COVID-19 pandemic has increased the demand for RNA raw materials, causing it to launch CDMO services in relevant fields. Hanmi Fine Chemical (Hanmi FC), a subsidiary of Hanmi Pharmaceutical Group, specializes in active pharmaceutical ingredients (APIs) development and production but is launching a new business to expand into the contract development manufacturing organization (CDMO) space. The company noted that the decision to move into the CDMO space has been driven by the COVID-19 pandemic, which…

May 25, 2022

Podcast: Opening the gates for women in biotech

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There is no lack of talented women in the biotech space but the gates blocking their progression must be open for them to fully realize their potential, says consultant Nadine Ritter. Companies’ Diversity, Equality, and Inclusion (DEI) policies are too often just an exercise in box-checking, said Nadine Ritter, president and analytical advisor at Global Biotech Experts and long-time member of BioProcess International’s editorial board. “If it’s just virtual signaling on a website then I don’t care… show me the…

May 25, 2022

High cost of complex biomanufacturing ‘a problem worth solving,’ says Waters

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With the cost of manufacturing accounting for as much as 70% for cell and gene therapies, industry must look to bioprocessing efficiencies and collaboration, says Waters Corporation. Waters Corporation is an analytical instruments, software, and service company. At the firm’s 2022 investor day last week, CEO Udit Batra spoke about the difference between producing small molecules, where “you get approval to produce a product with specific chemical and physical properties,” and the present biomanufacturing landscape, where the approval is for…

May 25, 2022

Moderna: ‘Speed to market approach’ for mRNA flu vaccine success

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Inherent challenges to traditional flu vaccine manufacturing can easily be overcome with messenger RNA (mRNA) says Moderna, which is moving a candidate into Phase III trials. The success of its COVID-19 vaccine Spikevax has encouraged Moderna’s pipeline of mRNA vaccines and therapeutics. Having already spoken brightly about the modality’s potential in tackling latent diseases – herpes, HIV, cytomegalovirus, for example – the company has lauded mRNA’s potential to overcome the “premature picking” issues seen in the yearly influenza vaccine production…

May 25, 2022