Author Archives: Dan Stanton

Lonza to support AstraZeneca’s COVID-19 antibody combo

Lonza will provide drug substance manufacturing for a potential COVID-19 monoclonal antibody combination therapy from its mid-scale facility in Portsmouth, New Hampshire. The deal, financials of which have not been disclosed, will see Swiss contract development and manufacturing organization (CDMO) Lonza make two monoclonal antibodies (mAbs) for AstraZeneca’s candidate AZD7442, currently in Phase I clinical studies as a potential treatment of COVID-19. The project will be one of the first from Lonza’s latest facility in Portsmouth, commissioned in 2018, with…

Novartis continues Kymriah capacity expansion with Japanese CDMO

Novartis has tripled production capacity for its commercial CAR-T therapy Kymriah over the past year and continues to ramp up through a deal with Japan’s Foundation for Biomedical Research and Innovation (FBRI). Kobe, Japan-based FBRI has received marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) to manufacture Kymriah (tisagenlecleucel) for Swiss pharma giant Novartis. The approval expands the manufacturing footprint of the chimeric antigen receptor (CAR) T-cell therapy, bringing Novartis its first Asian production facility. Furthermore, according…

Repligen strengthens downstream offering with $200m ARTeSYN acquisition

Repligen says it has established itself as a premier player in single-use systems, integrated flow paths, and assemblies following a triumvirate of bolt-on acquisitions. According to Repligen Corporation, ARTeSYN Biosolutions’ single-use chromatography and filtration systems are considered “the gold standards in downstream bioprocessing.” The technologies – along with three manufacturing facilities in Ireland, Estonia, and California – are soon to become part of Repligen’s offering after the firm entered a definitive agreement to buy ARTeSYN for $130 million cash and…

Lilly confident in remediating troubled COVID mAb plant

Eli Lilly has engaged an external firm to conduct a comprehensive independent review after the FDA found data integrity issues at a manufacturing facility in New Jersey. Earlier this month, Reuters broke the news that the US Food and Drug Administration (FDA) issued Eli Lilly’s Branchburg, New Jersey manufacturing site with an “Official Action Indicated” (OAI) notice. This came after an inspection in November last year found that processing data had been deleted and not appropriately reviewed by the firm’s…

Novartis awaiting Italian plant inspection for FDA’s Leqvio decision

Novartis is confident of maintaining a December 2020 action date for its high cholesterol siRNA therapy Leqvio despite common COVID-related regulatory delays of three to five months. Earlier this month, Novartis received positive opinion from the European Medicines Agency (EMA) for Leqvio (inclisiran), a small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. The Swiss pharma giant is hoping for the same in the US, with a PDUFA date set for December 31 2020…

Bayer adds AAV-based gene therapy tech in $2bn AskBio buy

The deal – which could be worth up to $4 billion – bolsters Bayer’s gene therapy ambitions through the addition of an AAV manufacturing platform, clinical-stage candidates, and a CDMO unit. German pharma giant Bayer is paying $2 billion up front with potential milestone payments up to another $2 billion for Research Triangle Park, North Carolina-based Asklepios BioPharmaceutical (AskBio). Founded in 2001 by Jude Samulski, the company’s present chief scientific officer, AskBio is developing gene therapies for neuromuscular diseases, central…

4D Pharma aims for NASDAQ as LBP space reaches maturity

In a deal worth up to $37.6 million, live biotherapeutic (LBP) developer 4D Pharma has agreed to merge with Longevity Acquisition Corporation. The proposed merger will see the UK-based LBP developer receive $14.6 million from Longevity and could benefit from the proceeds of warrants to purchase Longevity shares worth up to $23 million. Longevity Acquisition Corporation is a NASDAQ-listed Special Purpose Acquisition Comp (SPAC) meaning once the merger is completed, the entity will be admitted to trading on NASDAQ under…

Pall and Cytiva reaping $1bn coronavirus bonus for Danaher

Danaher Corporation says its bioprocessing businesses Pall Biotech and Cytiva have secured over $1 billion in COVID-19 related orders and expects further windfalls as vaccines and therapies reach approval. When the coronavirus pandemic emerged earlier this year, commentators noted the financial opportunity for bioprocess vendors in supporting industry’s efforts in developing and commercializing vaccines, therapeutics, and diagnostics. As the year progresses, these opportunities are materializing in quarterly statements, with Danaher Corporation the latest company showing a COVID-19 tailwind across its…

Thermo Fisher: ‘$700m COVID CapEx easily repurposed post-pandemic’

An additional $700 million capacity buildout to meet COVID-related demand will serve the longer-term non-pandemic-related biopharma market, says Thermo Fisher An unprecedented third quarter saw Thermo Fisher report a 36% rise in revenues year-on-year to $8.52 billion across all its segments. Its Life Sciences Solutions Segment – which includes its biosciences and bioproduction business units – saw a 101% rise to $3.42 billion, while its Laboratory Products and Services Segment – which includes drug manufacturing – increased by 19% to…

Swiss plant demonstrates synergies of KBI and Selexis acquisitions for JSR

A facility in Geneva will be home to two of JSR Life Sciences acquisitions offering customers both cell line development and drug substance manufacturing. Financial details of the new facility, occupying 8,700 square meters in the Stellar 32 campus in Geneva, Switzerland, have not been divulged, but will house both biologics manufacturer KBI Biopharma and cell line developer Selexis. Both companies are owned by JSR Life Sciences, a California-headquartered firm which has been upping its presence in the bioprocess space…