Author Archives: Millie Nelson

Selkirk plans $90m plant to boost US fill/finish capacity

The US needs more pharmaceutical manufacturing capacity on its own soil according to Selkirk Pharma, which has begun constructing a facility in Spokane, Washington.   The planned 145,000 square-foot Washington-based manufacturing plant has been designed for contract manufacturing of injectables drugs, therapeutics, and vaccines.  According to Selkirk CEO Patrick Haffey, the intent is “to build much-needed pharmaceutical manufacturing capacity on US soil.”  While the firm was founded prior to the pandemic, the realization of the fragility of supply chains in light of the coronavirus pandemic has brought in-country production to the forefront with firms like Avid Bioscience claiming it has made localized…

Novartis to close Swiss stability testing site by 2023

A move to specialized and personalized medicines has led Novartis to plan closure of a Swiss stability testing facility by 2023. Big Pharma has shifted its pipelines away from traditional small molecule drugs to biologics and regenerative medicine over the past 20 years. As such changing needs at Novartis has led the firm to announce it is closing its stability testing facility in Locarno, Switzerland by 2023. “Novartis plans to adapt its product testing capacity in Locarno, Switzerland, to the…

VIVEbiotech opens doors for lentiviral vector manufacturing  

The expanded lentiviral vector manufacturing plant will quadruple capacity, supporting VIVEbiotech’s cell and gene ambitions.   The contract development manufacturing organization (CDMO) said in February it would be adding 3,000 square feet to its existing facility in San Sebastian, Spain to ramp up manufacturing capacity and processes in response to lentiviral demand. The president of the Basque Government in Spain, Iñigo Urkullu and Pedro Duque, Minister of Science and Innovation of the Spanish government opened the facility on June 4. The opening ceremony…

Ins & outs: CureVac names new chief development officer

CureVac has named Klaus Edvardsen as its chief development officer. Meanwhile, there are changes at Gamida Cell and AavantiBio. Sit back, relax, and enjoy BioProcess Insider’s Ins & outs. Up first in this week’s Ins & Out’s we have mRNA firm CureVac, which has appointed Edvardsen as chief development officer effective from August 1, 2021. “We are very pleased that Klaus is joining us in highly dynamic times for the company,” said Franz-Werner Haas, CEO of CureVac. “He brings a wealth of…

Industry consortium takes aim at lowering CGT production costs

GSK, Cytiva, and Lonza are among 20 companies looking to develop technologies aimed at lowering the cost of cell and gene therapy production. Over 20 companies have been brought together by the Cell and Gene Therapy Catapult (CGT Catapult) to assess multiple process analytical technologies (PAT), which are new or frequently used in other sectors. This is the first consortium of this scale with the 20 companies consisting of technology providers, therapy developers, charities, and pharmaceutical firms. The consortium has…

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.”   She continued: “What we can say on our hiring stance is that we continue…

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,” 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…

Ins & outs: Apeiron Biologics expands management board

Apeiron Biologics makes high level changes to management and supervisory board. Meanwhile, there are changes at Relief Therapeutics. Sit back, put your feet up, and enjoy BioProcess Insider’s Ins & outs. Up first in this week’s Ins & Outs is Apeiron Biologics, a biotech firm that develops immunotherapies for respiratory diseases and cancer. According to the company, it is expanding its management board and supervisory board to meet the firm’s growth requirements. Romana Gugenberger has been appointed as chief medical and…