Moderna aims to up capacity for its COVID-19 vaccine to 1.4 billion doses through investment in ‘flexible’ manufacturing, which it says will offset any risk from variants or future overcapacity. What a year it has been for Moderna Therapeutics. For the fourth quarter 2020, the firm reported sales of $200 million – up from nothing the previous year – as regulatory approvals began rolling in for its messenger RNA (mRNA) COVID-19 vaccine mRNA-1273. Since it began working on a COVID-19…
The COVID-19 pandemic has highlighted the growing mammalian and viral vaccines market and placed Emergent in a “leading position†in the CDMO space, says CEO Bob Kramer. The fourth quarter 2020 produced record revenues for Emergent BioSolutions, with the firm reporting sales of $583 million, up 62% on the year prior. For the full year, sales tallied $1.56 billion, up 41% on 2019. While Emergent has its own product line (contributing $340 million in the quarter, with its smallpox vaccine…
Novo Nordisk plans to file an IND for cell therapy for type 1 diabetes in the next few years, setting the stage for a battle with Vertex which aims to start Phase I/II trials of its candidate this year. Denmark’s Novo Nordisk shared details of its stem cell-based candidate during its Q4 call recently, explaining it will submit the therapy along with several investigation new drug (IND) applications over the next few years. CSO Mads Thomsen told analysts “The first…
The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering…
COVID-19 has increased demand for viral vectors, exacerbating concerns that supply constraints could slow the growth of the cell and gene therapy sector. The ability to insert genetic material into cells using viral vectors is a cornerstone of the modern biopharmaceutical industry. Vectors are used to make everything from cell lines used to produce therapeutic proteins and monoclonal antibodies (mAbs) though to cell and gene therapies. Mismatch As a result, biopharma industry demand for vectors is strong. Indeed, a study…
In the latest episode of the BioProcess Insider Expression Platform, we explore the evolution of cell and gene therapy production with new COO of Lykan Bioscience, Patrick Lucy. From Repligen, to Lonza, to Pfenex, Patrick Lucy has had an illustrious career. His latest career move is to Lykan Bioscience, a Massachusetts-based contract Manufacturing Services Organization (MSO) and provider of end-to-end solution for cell-based therapies, where he took on the role of chief operating officer (COO) in January. In this podcast,…
Roche outlines ‘higher than originally expected’ sales impact from biosimilars worldwide. Roche announced in full year results for 2020 that biosimilars to Herceptin (trastuzumab), Avastin (bevacizumab), and MabThera/Rituxan (rituximab) dented sales by CHF 5.7 billion ($6.34 billion) worldwide. Roche group’s CEO, Severin Schwan, commented in an investor call after the results were revealed that “the impact of biosimilars was significant, somewhat higher than we originally expected.†As a result, sales in the company’s pharmaceuticals division decreased by 8% to CHF…
CytoImmune Therapeutics and Biosimilar Sciences will invest a combined total of $228 million to set up operations in Puerto Rico. The plan – which was announced by Invest Puerto Rico last week – will see the firms perform novel biologics and cell therapy research and development and hire around 400 employees. A CytoImmune spokesman told us “We chose Puerto Rico due to talented workforce, experienced Pharma service providers, tax incentives, excellent access to US and worldwide shipping, US manufacturing. He…
Pfizer says it is relatively simple to rejig the formulation and manufacturing infrastructure for its approved mRNA vaccine in the case of COVID-19 variants. Following a year that saw Pfizer bring to the US and Europe the first vaccine against COVID-19, the firm has raised its production targets for 2021 from 1.3 billion doses to 2 billion doses, and expects to deliver 200 million doses to the US by end of May. “Because of the dire need to vaccinate more…
Tried and tested technologies, a single-dose regimen, and a simple cold-chain infrastructure place Johnson & Johnson’s potential COVID-19 vaccine at an advantage over the current approved offerings. Johnson & Johnson (J&J) has said it plans to present results of its COVID-19 candidate JNJ-78436735, also known as Ad26.COV2-S, recombinant, in the next few days. “Being in the final stages of a robust 45,000-person study, analytics will be completed, and we plan to report out the results by early next week,†CFO…