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Cytiva has completed the Modular Biologics factory for Lonza.

Cytiva has recently completed another KUBio installation to Lonza, in Guangzhou Biopark, China.  This is Lonza’s first manufacturing site for biologics in China. Lonza will combine Cytiva’s KUBio modular facility and single-use equipment to support its Good Manufacturing Practice (GMP) manufacturing integrated with its platforms and expertise in development, including cell line construction and process development.

The new site occupies a 17,000-square-meter including 6,500 square meters of lab space and one KUBio modular facility, which will enable fast ramp-up of antibody development services and manufacturing, which are urgently needed to respond to market needs.

Guangzhou Biopark is also home to manufacturing sites for BeiGene and Akesobio, where Cytiva also provided solutions.

(Source: PR News Wire, 2021)

Biond Biologics and Sanofi Enters into Global Licensing Agreement for BND-22.

Biond Biologics recently announced that the company has entered into an exclusive worldwide license agreement with Sanofi, for the development and commercialization of BND-22. 

BND-22 is a humanized IgG4, antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds MHC class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types. 

An Investigational New Drug (IND) application for BND-22 has already been submitted to the Food and Drug Administration (FDA) and a Phase 1 study to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 in advanced cancer patients is expected to commence in the middle of the year. 

Under the terms of the agreement, Biond will receive a $125 million upfront payment and will be entitled to receive more than $1 billion in development, regulatory, and sales milestones, as well as tiered double-digit royalty payments. Biond will be responsible for leading the first-in-human, Phase 1a study of BND-22 to evaluate its safety and tolerability while Sanofi will be in charge of the clinical development and commercialization activities.

(Source: PR News Wire, 2021)

Thomas Health opens its Monoclonal Antibody Infusions Center

Thomas Health has recently opened a Monoclonal Antibody Infusion Center at Thomas Memorial Hospital.

According to Thomas Health, Monoclonal Antibody therapy is an intravenous infusion performed over one hour with observation for one hour afterward. Patients have to meet the criteria for the therapy.

Thomas Health’s Chief Medical Officer, Dr. Matthew Upton said that Monoclonal Antibody administration is a new form of way of treatment for COVID-19. The point will be the early diagnosis of COVID-19 and infusion of the monoclonal antibodies within 10 days of the onset of symptoms which are offered in the center. 

The hospital says they have served ten patients since its opening from the week before. 

(Source: WSAZ News Channel 3, 2021)