Author Archives: Ben Hargreaves

rBIO launches aiming to increase manufacturing output of insulin

rBIO plans to lower cost of insulin by 30% through the ‘hyper-expression’ of newly-developed strains of bacteria. The start-up company is launched out of San Francisco and arrives alongside the news that it has successfully synthetically produced human insulin, using E. coli bacteria as the host for recombinant DNA synthesis. According to rBIO, the next stages for the biotech are to upscale production of insulin and to identify other prescription drugs that can be manufactured using its approach. Already the…

Boehringer urges FDA to correct ‘strength’ definition for biosimilars

Boehringer Ingelheim has filed a Citizen Petition to the US FDA to change its interpretation of how the strength of a biosimilar is determined. Boehringer Ingelheim filed the petition to the US Food and Drug Administration (FDA) last week to change the interpretation of the word ‘strength’ to mean total drug content. Currently, the FDA’s interpretation is based on both the total content of drug substance and the concentration of drug substance. In its Citizen Petition, Boehringer claims that this…

KBI adds $150m commercial facility alongside pharma partner

KBI Biopharma will establish a commercial manufacturing facility in North Carolina with a co-investor, due to be operational Q1 2022. The contract development and manufacturing organization (CDMO) is developing the facility alongside an unnamed pharmaceutical partner to support the manufacture of the latter’s therapeutic protein programs. KBI will provide current good manufacturing practice (cGMP) biologics manufacturing for the partner, with a spokesperson for KBI Biopharma confirming that this would represent a “significant amount of [total] capacity.” However, the site will…

European Commission considers regulation for ‘bedside’ manufacturing

The European Commission has published its pharmaceutical strategy to increase access to innovative and safe medicine, including steps to adapt regulation to advanced therapies. The ‘Pharmaceutical Strategy for Europe’ was announced last week by the European Commission (EC) in order to strengthen and protect the European Union’s pharmaceutical supply chain, in light of medical innovation and the on-going pandemic. Within the subsection entitled ‘Enabling innovation and digital transformation’, the first example of innovation given is advanced therapies. In particular, the…

Resilience launches with $800m to ‘break’ biomanufacturing bottlenecks

Though details are scarce, Resilience claims it will provide ‘new, better, faster ways’ to manufacture cell and gene therapies. The new entity begins with bases in Boston and San Diego, as well as over 750,000-square-feet of operating space. Officially known as ‘National Resilience’, the company announced its entrance on the market by suggesting that it would be a ‘first-in-kind’ biomanufacturing and technology operation that has been set up specifically to address capacity issues in the advanced therapeutics area. Resilience plans…

SaudiVax works with Cytiva to produce halal vaccines

Cytiva provides its FlexFactory solution, as SaudiVax looks to meet vaccines and biologics demand in the Middle East and Africa. The FlexFactory platform is being installed as part of Saudi Arabia’s Saudi Vaccine and Bioprocessing Center (SVBC), which will become the first bioprocessing facility for halal vaccines in the region. It also represents new ground for Cytiva, with the FlexFactory installation being the first for the company in the Middle East and North African (MENA) region. The SVBC is backed…

Vibalogics launches US expansion with $150m virotherapy plant

CDMO Vibalogics plans for its late-phase clinical and commercial manufacturing facility to be operational in 2021. Vibalogics, a contract development and manufacturing organization (CDMO) specializing in oncolytic viruses, viral vector vaccines and viral vector gene therapy products, has entered the ‘Phase I’ stage of the investment into the site. The three-year project will see a 110,000-square-foot facility constructed near Boston, Massachusetts, which will be operational in the second half of 2021. This investment follows on from the German company’s expansion…

Altimmune partners with Lonza on intranasal COVID-19 vaccine

The two companies ready AdCOVID for a commercial launch in 2021, with a clinical trial to begin in Q4. The next-generation of COVID-19 vaccines is already being developed, even with the first generation yet to reach the public. The companies involved are finding ways to differentiate their vaccines from the previous generation. This has led companies, such as Vaxart, to produce oral vaccine candidates and sees Altimmune further advance its intranasal vaccine candidate by signing a manufacturing deal with Lonza.…

TCR2 makes first steps into US with ElevateBio manufacturing deal

TCR2 Therapeutics has established manufacturing capacity in the US, as it looks to Phase II trials for its solid tumor candidate TC-210. ElevateBio will provide manufacturing and technical expertise for TC-210, a cell therapy that is currently in Phase I/II trials and being prepared to enter Phase II. The production will take place at ElevateBio’s BaseCamp, a 140,000-square-foot cell and gene therapy manufacturing facility based in Waltham, US. ElevateBio secured the funding for the site and its operations last year,…

Hiring staff ‘extra challenging’ during pandemic, says Emergent VP

Emergent tries to fill bioprocessing talent gaps as it works to meet COVID-19 manufacturing demand. When the pandemic hit earlier this year, Emergent Biosolutions found its services as a specialist in vaccine development and manufacturing sought after by a number of leading efforts against COVID-19. The company’s contract development and manufacturing organization (CDMO) business unit found itself well placed, having already built up its capacity specifically to counter a pandemic alongside the US government. Alongside its newly found popularity as…