Author Archives: Millie Nelson

Samsung Biologics adding mRNA capabilities at Korean facility

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The CDMO will add mRNA manufacturing capabilities to its Songdo plant by the first half of 2022.   Through adding messenger RNA (mRNA) vaccine drug substance production capability to its Songdo facility, Samsung Biologics will be able to provide end-to-end mRNA services.   The contract development manufacturing organization (CDMO) has not disclosed any financial details and a spokeswoman for Samsung Biologics told BioProcess Insider “It would be rather difficult for us to disclose the equipment, skills and financials as the technology’s very new and such information is directly related our competitiveness.â€Â Â  She continued: “What we can say on our hiring stance is that we continue…

June 7, 2021

MilliporeSigma ups lipid capacity by 50x to meet COVID-19 demand

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To meet the high demand for lipids, MilliporeSigma has launched its high-purity synthetic cholesterol product nine months early.  “By launching our new SAFC synthetic cholesterol product nine months early, we are able to meet the high demand for lipids that we’re seeing due to the COVID-19 pandemic, as lipids are a key component of mRNA-based vaccines and therapeutics,â€Â Matthias Bucerius, head of Actives & Formulation at MilliporeSigma told us.   The early launch of its cholesterol product has increased its capacity by 50 times.   According to the contract development manufacturing organization (CDMO),…

June 4, 2021

EMA backs expansion of Pfizer’s Belgium facility for COVID-19 vaccine supply

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The European Medicines Agency has recommended the approval of additional manufacturing capacity at Pfizer’s Puurs, Belgium facility for its COVID-19 vaccine. The expansion, of which no financial details have been disclosed, aims to install additional manufacturing and filling lines. According to the EMA, the recommendation given by the Agency’s Committee for Human Medicines (CHMP) will have a significant and direct impact on the supply of Pfizer’s COVID-19 vaccine. The firm’s partnership with BioNTech saw Pfizer become the first company to…

June 3, 2021

Dyadic: For COVID-19 vaccines, ‘we have what the world needs’

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The industry needs to rethink COVID-19 vaccine production according to Dyadic, which says its fungus-based expression system could supply the world at a lower cost than current mRNA offerings. As the global COVID-19 vaccine rollout continues and companies like Moderna and Pfizer become household names, Dyadic CEO Mark Emalfarb told BioProcess Insider its C-1 cell protein production platform could potentially produce “antigens, quicker, faster, and in larger volumes at a lower cost.†He continued: “We could have seeded the world…

June 2, 2021

Ins & outs: Apeiron Biologics expands management board

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Apeiron Biologics makes high level changes to management and supervisory board. Meanwhile, there are changes at Relief Therapeutics. Sit back, put your feet up, and enjoy BioProcess Insider’s Ins & outs. Up first in this week’s Ins & Outs is Apeiron Biologics, a biotech firm that develops immunotherapies for respiratory diseases and cancer. According to the company, it is expanding its management board and supervisory board to meet the firm’s growth requirements. Romana Gugenberger has been appointed as chief medical and…

June 1, 2021

Danaher boosts lipid services through PNI acquisition

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Danaher will increase its lipid service offerings through the acquisition of Canadian-based technology and solution firm Precision Nanosystems. The deal, of which financials have not been disclosed, sees lipid nanoparticle tech firm Precision Nanosystems (PNI) join Danaher Corporation’s family of life science companies, which include Cytiva and Pall. PNI offers consumables, equipment, and reagents to help manufacture lipid nanoparticles for the delivery of genetic medicines, including messenger RNA (mRNA) therapeutics and vaccines. Through the acquisition, Danaher gains PNI’s GenVoy delivery…

June 1, 2021

Swiss gov helps Lonza recruit staff to manufacture Moderna vaccine

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The Swiss government has recruited at least 25 workers to operate the production lines at Lonza’s facility in Visp. Contract development manufacturing organization (CDMO) Lonza has been supporting Moderna since May 2020 to manufacture its cell-free messenger RNA (mRNA) COVID-19 vaccine. However, there have been concerns regarding supply delays and it was even alleged the CDMO had tapped fellow Swiss company Nestle for workers in order to service its deal to produce drug substance for hundreds of millions of doses of Moderna’s…

May 28, 2021

Avid secures commercial manufacturing contract for ADC’s Zynlonta

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ADC Therapeutics’ recently approved cancer treatment Zynlonta will be commercially manufactured by Avid Bioservices in Tustin, California.   Contract development manufacturing organization (CDMO) Avid Bioservices will manufacture the monoclonal antibody portion of the antibody-drug conjugate (ADC) Zynlonta (loncastuximab tesirine), which received US Food and Drug Administration (FDA) approval in April. Avid has provided ADC Therapeutics with clinical manufacturing services since 2017. However, the firm will now undertake commercial manufacturing activities for Zynlonta, which is used to treat patients with relapsed or…

May 26, 2021

Korean CDMOs come into play to support global COVID-19 supply

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Moderna has inked a deal with Samsung Biologics and Novavax has signed a memorandum of understanding with SK bioscience to provide global access to their vaccines. Novavax has not yet received authorization for its recombinant protein COVID-19 vaccine candidate NVX-CoV2373 but it is prepping for commercialization, signing a non-binding memorandum of understanding (MoU) with the Ministry of Health and Welfare of Korea and contract development manufacturing organization (CDMO) SK bioscience. Under the terms of the agreement, SK bioscience will continue…

May 26, 2021

Biogen partners with Gingko to develop gene therapy platform

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Biogen will use Gingko Bioworks’ mammalian cell programming platform to help advance its AAV-based vector manufacturing. Under the terms of the agreement, Gingko will provide Biogen with access to its cell programming capabilities and platform. Gingko will use its bioengineering resources and biomanufacturing space to enhance Biogen’s AAV production titers in its gene therapy manufacturing processes. Biogen will pay $5 million upfront, but Gingko has the potential to receive $115 million depending on research, development, and commercial milestones. Biogen says…

May 25, 2021