Global Markets

Industry calls for standardization and simplification to boost manufacturing agility

Executives from Novavax, Fujifilm, and Biocon have called for standardized processes and simplified regulations after a Cytiva-led survey showed improving manufacturing agility is a major priority for biopharma. A survey of around 1,100 senior executives across 20 countries commissioned by bioprocess vendor Cytiva has highlighted industry’s confidence in the biopharma space. With respondents scoring several sectors within the industry, the Biopharma Resilience Index averaged an overall score of 6.6 out of 10. But according to Hannah Freegard, senior editor at…

Moderna investing $400m in mRNA capacity for COVID-19 and beyond

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…

Emergent CDMO biz ‘thriving’ in COVID-19 environment

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 and Vertex update on rival diabetes cell therapy efforts

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…

eBook: Vaccines — COVID-19 Invigorates a Stagnant Industry

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 put more pressure on vector suppliers, says expert

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…

Podcast: Industry veteran moves to Lykan Bioscience, and this time its personal!

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 hit for $6.3bn due to biosimilar competition

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…

Workforce, tax incentives and US access attract more biotechs to Puerto Rico

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 cites ‘simplicity’ of mRNA production to overcome COVID-19 variants

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…