Author Archives: Millie Nelson

AM-Pharma expands KBI partnership for kidney disease candidate

The agreement will advance AM-Pharma’s recAP program towards commercialization with KBI providing drug substance manufacturing and regulatory support. AM-Pharma’s recombinant human Alkaline Phosphatase (recAP) program is a potential treatment for Sepsis-Associated Acute Kidney Injury (SA-AKI). Acute kidney disease affects hundreds of thousands of people globally and currently has no authorized pharmacological treatments. Both firms partnered in 2011 to develop the program, which saw contract development manufacturing organization (CDMO) KBI Biopharma provide initial process development and manufacturing for early clinical use.…

Evonik and Stanford collaborate to go beyond the capabilities of LNPs

Evonik and Stanford will begin a three-year research collaboration to develop a polymer-based drug delivery system for mRNA therapeutics. German contract development manufacturing organization (CDMO) Evonik will license and commercialize Stanford University’s polymer-based drug delivery system, which enables broader use of messenger RNA (mRNA). The CDMO work will take place at Evonik’s facilities in Vancouver, Canada and Birmingham, USA. “The platform is called CART (Charge Altering Releasable Transporters),” vice president of R&D, Innovation for Evonik Stefan Randl told BioProcess Insider.…

GSK pays iTeos $625m for anti-TIGIT mAb

GSK has the leading portfolio of antibodies targeting immune-oncology therapies as it agrees to co-develop and commercialize EOS-448 with iTeos. British firm GlaxoSmithKline (GSK) has agreed to an upfront payment of $625 million to iTeos Therapeutics. However, the deal could be worth $1.45 billion with potential milestones and royalty payments dependent on the success of EOS-448. EOS-448 is an anti-T cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody (mAb), which is currently in Phase I development as a…

Ins & outs: BIO adds board members, and new CEO for Astrea

Astrea has named Terry Pizzie as chief executive officer. Meanwhile, new officers join BIO’s governing board. Sit back, relax, and enjoy BioProcess Insider’s Ins & outs. Kick starting this week’s Ins & Out’s is Astrea Bioseparations (operating company of Gamma Biosciences), which has appointed Terry Pizzie to succeed Steve Burton as CEO. “Steve has been a key leader at Astrea Bioseparations since its early days as a spin out from the University of Cambridge and will continue as such in his new role…

Entegris invests $30m to expand life sciences capabilities

To address increased demand for bioprocessing assemblies, Entegris will invest $30 million to expand three manufacturing facilities. The material and process solutions firm Entegris will expand three of its life sciences manufacturing sites located in Billerica; Massachusetts, Bloomington; Minnesota, and Logan; Utah. “This expansion is in response to the increased pharmaceutical demand for single use high purity bulk systems, especially the ones for freezing, transporting, storing, and thawing drug substances. And obviously, there’s a big challenge for the COVID-19 vaccines,”…

GenScript to distribute Calidi’s ‘trojan horse’ cell therapy tech

GenScript ProBio will promote and advertise Calidi Biotherapeutics’ allogeneic cell technology platform SNV-1 to current and future clients. Under the terms of the agreement, Calidi will train and equip the Genscript sales team to present its SuperNova-1 (SNV-1) technology to their current customers. According to the firm, it recognizes the problems that surround oncolytic viruses as the immune system of the patient attacks and eliminates a large amount of the oncolytic virus from the body. “In many cases, 95%+ of…

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…