Author Archives: Dan Stanton

Biogen Swiss site GMP ready for aducanumab launch

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Biogen has received GMP certification at its Solothurn, Switzerland facility ahead of a regulatory decision for potential Alzheimer’s drug aducanumab. Biogen commissioned the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, in 2015, stating at the time it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons. Last week, Swiss Agency for Therapeutic Products (SWISSMEDIC) granted the facility a Good Manufacturing Practice (GMP) multi-product license,…

May 24, 2021

N-SIDE launches app to optimize clinical manufacturing supply chain

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The Production App has already saved one biopharma firm €10.5 ($12.8) million by optimizing manufacturing planning within the uncertainty of the R&D process, says N-SIDE. N-SIDE has a suite of software aimed at optimizing the entire clinical trial supply chain management process from production planning through to protocol design and delivery of supplies to patients. The latest offering, known as ‘The Production App,’ focuses on helping biopharma firms manage the complexities and uncertainties of manufacturing clinical material and according to the…

May 21, 2021

Chime’s in: Humanigen adds Chinese CDMO to support COVID mAb

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Humanigen has contracted Chime Biologics to supply its potential COVID-19 therapy lenzilumab outside of the US. Lenzilumab is in late-stage trials as a treatment for ‘cytokine storm’, an overreaction of the immune system, which has occurred in those suffering from COVID-19. With planned emergency use authorization (EUA) submissions in the US by the end of May and in the UK and Europe thereafter, Humanigen has increased its manufacturing capacity through a contract with Wuhan, China-based Chime Biologics. “Globally there is…

May 19, 2021

Podcast: On board the Cell Shuttle with Cellares

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Cellares Corporation’s CEO Fabian Gerlinghaus talks about the current limitations in cell therapy production and how, with $82 million in hand, its Cell Shuttle technology could resolve these. Tech firm Cellares Corporation is looking to advance development of its cell therapy manufacturing platform, the Cell Shuttle. Having raised $82 million in its latest funding round, co-founder and CEO Fabian Gerlinghaus spoke about how the Cell Shuttles’ scalable, modular, and automated nature could be a gamechanger in the burgeoning space on…

May 11, 2021

Richter-Helm to triple biologics capacity through €70m investment

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German CDMO Richter-Helm will install both stainless-steel and single-use technologies at a new facility at its Bovenau site, increasing total biomanufacturing capacity three-fold. Self-proclaimed mid-sized contract development and manufacturing organization (CDMO) Richter-Helm has facilities in Hannover and Bovenau, Germany, with bioreactor capacities of up to 1,500 liters. But the CDMO is looking to benefit from continuous growth in demand for biomanufacturing capacity and services, and on May 5 broke ground on a new €70 million ($85 million) at the Bovenau…

May 11, 2021

Allogene and Regenxbio point to inhouse CGT advantage

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With facilities set to come online in California and Maryland, Allogene and Regenxbio respectively are the latest advanced therapy firms to laud the advantages of inhouse production. Allogene launched in 2018 with backing from Pfizer and has progressively been developing its AlloCAR T allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. Its lead candidate is ALLO-501A looking to move into Phase II studies for Non-Hodgkin Lymphoma later this year. The company hopes to support the trial and beyond through…

May 10, 2021

Fill & finish investments plus pandemic drive Catalent’s biologics biz

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Biologics now represent over half of Catalent’s revenues with the firm citing drug product manufacture as a major driver. For a number of years, contract development manufacturing organization (CDMO) Catalent has been tipping the balance of its business away from its small molecule and delivery technology heritage, and towards its biologics business. The biologics business pulled in around 32% of Catalent’s business mix in 2019, but in under two years the division pulled in over half of the CDMO’s net revenues…

May 6, 2021

Eppendorf $100m of capacity expansions reflects record year

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Eppendorf says it will continue investing in production capabilities and infrastructure as it reports a record 12 months. German life sciences tool provider Eppendorf reported revenues of €967 million($1.16 billion) for its fiscal year 2020, up 20.3% on the year prior. “2020 was by far the most successful fiscal year for the Eppendorf Group,†co-CEOs Eva van Pelt and Peter Fruhstorfer said in a joint statement. Like many of its fellow bioprocess suppliers, growth in sales across many of Eppendorf’s…

May 6, 2021

Survey highlights lack of minority leadership in life science space

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The lack of ethnic minorities and women in leadership roles is the biggest problem with diversity and inclusion in the life sciences space, according to a survey from Informa Connect. Over 480 people working across the life sciences space responded to a survey entitled ‘Diversity, Equity and Inclusion in the Life Sciences 2021,’ conducted by Informa Connect in March, and the results are now in. While respondents stressed that a combination of many problems plagued our industry, over a third…

May 6, 2021

SBI hoping to kickstart digital bioprocessing revolution through aquila buy

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Scientific Bioprocessing (SBI) says it is aiming to create a digital platform to enhance biopharmaceutical workflow through the acquisition of smart sensor and data analytics firm aquila biolabs. Life sciences tool supplier Scientific Industries, through its subsidiary SBI, has acquired aquila biolabs, adding smart sensors and data analytics software for bioprocessing along with facilities in Baesweiler, Germany. “From the earliest interactions with the aquila biolabs team, it became really apparent that we shared the vision of developing technologies that can…

May 5, 2021