Author Archives: Millie Nelson

eTheRNA inks mRNA partnership with Merck KGaA

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The collaboration will study the application of eTheRNA’s mRNA and LNP-delivery platforms to disease areas picked by Germany’s Merck. The research collaboration will target messenger RNA (mRNA) therapeutics using eTheRNA’s mRNA and lipid nano particle (LNP) technologies in various model systems. If successful, mRNA encoding antigens will be nominated by Merck KGaA relevant for human diseases. “eTheRNA has developed a platform of differentiated mRNA capabilities clinically proven to modulating the dendritic cell-T-cell interactions that are at the heart of all…

February 17, 2022

Robert Califf named as FDA commissioner

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On Tuesday the Senate voted to confirm Robert Califf as the next commissioner of the US Food and Drug Administration (FDA). The US FDA has not had a permanent leader since January 2021 and in November last year President Joe Biden nominated former FDA commissioner Robert Califf to lead the organization for a second time. Now, in a tight vote resulting in 50 in favor of Califf and 46 against, he returns to the position he served in from 2016…

February 16, 2022

Thermo Fisher forks out $40m to expand single-use plant

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The $40 million expansion will support production of single-use technology for vaccines and therapeutics at Thermo Fisher’s Pennsylvania facility. According to Thermo Fisher Scientific, the expansion of its single-use technology (SUT) manufacturing facility in Millersburg, Pennsylvania is part of a long-term $650 million investment the firm announced last March. Additionally, the investment will establish secure, scalable, reliable, and flexible bioprocessing production capacity for materials used in current and future biologics and vaccines, including COVID-19 treatments. “The integration of single use…

February 16, 2022

MilliporeSigma: Talent shortages will remain an ongoing issue in 2022

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Talent retention and attraction will be the biggest challenge firms face in 2022, says MilliporeSigma’s head of Process Solutions Andrew Bulpin. Talent shortages in the biopharma space have been globally reported with professionals forming a general consensus that the industry’s growth does not match the amount of talent coming through. While certain countries like Lithuania claim it has a talent pool ready and waiting, other global companies such as Lonza, SwedenBIO, pharma recruitment firm Lead Candidate, and Cell and Gene Therapy Catapult expressed their…

February 14, 2022

US Gov awards $250m botulinum contract to Resilience

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Resilience subsidiary Ology Bioservices has been awarded a $250 million contract by the US DOD to develop a monoclonal antibody as a medical countermeasure to botulinum neurotoxins. Under the terms of the deal, Ology Bioservices (acquired by San Diego-based contractor – National Resilience in April 2021) will advance the medical countermeasure (MCM) to the US Food and Drug administration (FDA), which will then be manufactured at commercial scale with stock distributed for military use. The firm’s site in Alachua, Florida,…

February 14, 2022

J&J fully on board COVID vax despite manufacturing halt reports

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With millions of COVID-19 doses on hand and reports that J&J has halted production, we ask whether it has changed its vaccine manufacturing strategy. This week the New York Times reported that Johnson & Johnson (J&J) has temporarily halted production of its COVID-19 vaccine from its Leiden, The Netherlands site claiming that it is producing an experimental “but potentially more profitable vaccine to protect against an unrelated virus,†instead. A spokesperson for J&J told BioProcess Insider its Leiden site “Continues…

February 11, 2022

Pfizer bags $37bn from COVID vax with another $32bn expected in 2022

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Pfizer has lauded its clinical development and vaccine manufacturing capabilities as it hopes to produce a total of 4 billion doses of Comirnaty by the end of 2022.  Through its partnership with BioNTech, Pfizer became the first company to bring a messenger RNA-based product to market, namely the COVID-19 vaccine Comirnaty (BNT162b2), which received emergency use approval in December 2020.  This week, Pfizer told shareholders during its Q4 2021 earnings call that the jab has generated $36.8 billion sales worldwide for…

February 10, 2022

Lonza cites RealHope to improve DP services

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Lonza’s drug product services division is participating in the RealHope project to establish challenges that contribute to protein instability during the handling process. The Real-World Handing of Protein Drugs – Exploration, Evaluation and Education (RealHOPE) project aims to destabilize protein-based therapeutics by measuring real-life events during drug handling to significantly improve the safety and effectiveness of the drug development process. According to Swiss contract development manufacturing organization (CDMO) Lonza, assessing protein stability is required to ensure process optimization and the…

February 8, 2022

Intellia expands gene editing toolkit with $45m Rewrite buy

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The deal will see Intellia Therapeutics add Rewrite Therapeutics’ DNA writing platform and expand its CRISPR functionality. Under the terms of the deal, Intellia, a genome editing firm which uses CRISPR-based technologies will pay Rewrite Therapeutics’ shareholders $45 million in an upfront payment and an additional $155 million in pre-agreed research and regulatory milestones. According to Intellia, the University of California, Berkeley spinout will provide technology that is “highly complementary†to its CRISPR/cas9 and base editing technologies. “Rewrite has developed…

February 7, 2022

AES Clean Technology to build $14.2m Pennsylvania plant

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AES says it will be able to meet current and future cleanroom demand through the construction of a facility in Lancaster County, Pennsylvania, AES Clean Technology, a provider of cleanroom facilities within the pharmaceutical and biopharmaceutical industry said the facility will expand its production capabilities to match industry growth, especially for clients responsible for the production of COVID-19 treatments and advanced bio-therapeutics. “We see several factors that are driving the decision to add this new capacity. There is a real…

February 7, 2022