Facilities & Capacity

Samsung Biologics adding mRNA capabilities at Korean facility

The CDMO will add mRNA manufacturing capabilities to its Songdo plant by the first half of 2022.   Through adding messenger RNA (mRNA) vaccine drug substance production capability to its Songdo facility, Samsung Biologics will be able to provide end-to-end mRNA services.   The contract development manufacturing organization (CDMO) has not disclosed any financial details and a spokeswoman for Samsung Biologics told BioProcess Insider “It would be rather difficult for us to disclose the equipment, skills and financials as the technology’s very new and such information is directly related our competitiveness.â€Â Â  She continued: “What we can say on our hiring stance is that we continue…

Resilience to support AavantiBio’s gene therapy programs long-term

AavantiBio has hired Resilience to make its gene therapies candidates, including a therapy for the currently untreatable progressive disorder Friedreich’s Ataxia (FA). Under the contract – described as a strategic collaboration – Resilience will provide process development and manufacturing as well as including cell lines and viral banks for in pre-clinical studies and clinical trials. The contract development and manufacturing organization (CDMO) will also develop and optimize processes for AvantBio’s other candidate therapies, with all of the work scheduled to…

MilliporeSigma ups lipid capacity by 50x to meet COVID-19 demand

To meet the high demand for lipids, MilliporeSigma has launched its high-purity synthetic cholesterol product nine months early.  “By launching our new SAFC synthetic cholesterol product nine months early, we are able to meet the high demand for lipids that we’re seeing due to the COVID-19 pandemic, as lipids are a key component of mRNA-based vaccines and therapeutics,â€Â Matthias Bucerius, head of Actives & Formulation at MilliporeSigma told us.   The early launch of its cholesterol product has increased its capacity by 50 times.   According to the contract development manufacturing organization (CDMO),…

EMA backs expansion of Pfizer’s Belgium facility for COVID-19 vaccine supply

The European Medicines Agency has recommended the approval of additional manufacturing capacity at Pfizer’s Puurs, Belgium facility for its COVID-19 vaccine. The expansion, of which no financial details have been disclosed, aims to install additional manufacturing and filling lines. According to the EMA, the recommendation given by the Agency’s Committee for Human Medicines (CHMP) will have a significant and direct impact on the supply of Pfizer’s COVID-19 vaccine. The firm’s partnership with BioNTech saw Pfizer become the first company to…

Dyadic: For COVID-19 vaccines, ‘we have what the world needs’

The industry needs to rethink COVID-19 vaccine production according to Dyadic, which says its fungus-based expression system could supply the world at a lower cost than current mRNA offerings. As the global COVID-19 vaccine rollout continues and companies like Moderna and Pfizer become household names, Dyadic CEO Mark Emalfarb told BioProcess Insider its C-1 cell protein production platform could potentially produce “antigens, quicker, faster, and in larger volumes at a lower cost.†He continued: “We could have seeded the world…

Moderna further expands CDMO partnerships to support COVID vaccine

A triumvirate of CDMO expansions will increase production of Moderna’s COVID-19 vaccine: Lonza will repurpose a suite at a Dutch facility to up drug substance, and Aldevron will increase plasmid DNA supply. Meanwhile, Thermo Fisher will provide fill/finish capacity from North Carolina, as will Samsung Biologics from korea. Last month, Moderna announced plans to increase both internal and third-party production of its mRNA COVID-19 vaccine, currently being rolled out under an FDA Emergency Use Authorization (EUA). This included making an…

Swiss gov helps Lonza recruit staff to manufacture Moderna vaccine

The Swiss government has recruited at least 25 workers to operate the production lines at Lonza’s facility in Visp. Contract development manufacturing organization (CDMO) Lonza has been supporting Moderna since May 2020 to manufacture its cell-free messenger RNA (mRNA) COVID-19 vaccine. However, there have been concerns regarding supply delays and it was even alleged the CDMO had tapped fellow Swiss company Nestle for workers in order to service its deal to produce drug substance for hundreds of millions of doses of Moderna’s…

UPenn gene therapy researchers lease space at Discovery Labs

University of Pennsylvania gene therapy researchers have leased space at Discovery Labs’ facility in King of Prussia in a deal designed to expand vector production capacity. The agreement – financial terms of which have not been disclosed – includes two dedicated floors at Discovery Labs’ campus on Swedeland Road. The leased space will house the Penn Vector Core, which is a full-service viral vector manufacturing operation. At present Penn produces viral vectors for use in gene transfer. It supplies vectors…

Biogen Swiss site GMP ready for aducanumab launch

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,…

Thermo teams with UCSF on San Fran cell therapy center

Thermo Fisher Scientific has teamed up with the University of California, San Francisco (UCSF) to set up a cell therapy manufacturing center. The facility – which will be at USCF’s Mission Bay campus in San Francisco – will offer clinical and commercial cGMP cell therapy manufacturing services and technology development support. According to Thermo Fisher, the facility, which is due to open next year, will serve as a central location where customers and UCSF researchers will have access cell therapy systems, reagents,…