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Thermo Fisher’s investments on flexible scalable biologics developments. 

Thermo Fisher Scientific has recently opened a new bioprocessing collaboration center adjacent to its biologics manufacturing facility in St Louis, Missouri. Located near the company’s GMP biologics manufacturing facility, the teams at both locations will be able to rapidly provide feedback and innovate in real-time.

The new facility is also expected to deliver new single-use bioprocessing technologies to optimize SUT performance in the industry. For example, they will begin in expanding single-use technology to a larger range of molecules, simplifying scalability from 5 to 5,000 L, and launching a new harvesting solution that will remove bottlenecks and significantly accelerate production.

Thermo Fisher has been continuously investing in its facilities to help its biopharma customers accelerate its development and commercialization efforts.

(Source: Biopharma Reporter, 2020)

Samsung Biologics and Panolos Bioscience partners for solid tumor treatment. 

Samsung Biologics has entered into a service agreement with Panolos Bioscience to develop PB101, an Fc-fusion protein intended to treat solid tumors.

Under this agreement, Samsung Biologics will provide a full scope of its development services from cell line development, process development, to non-clinical and clinical material manufacturing.

PB101 is expected to suppress tumor angiogenesis more effectively by targeting VEGF-A and PlGF simultaneously, overcoming the limitations of existing treatments. Panolos hopes to receive an IND approval for validation to further establish the substance as the new platform known as αARTTM(anti-angiogenesis-based Artifact Re-targeting Tri-specifics) to treat various VEGF related illnesses.

Both companies are delighted with the newly forged partnership as they strive to deliver quality biopharmaceuticals to address unmet global medical needs.

(Source: PR News Wire, 2020)

MediWound Announces FDA Approval in Reviewing Biologics License Application for NexoBrid. 

MediWound recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. 

MediWound’s Chief Executive Officer, Sharon Malka says that they are delighted with the recent major milestone and is excited that they are one step closer in bringing a treatment for an unmet medical need. 

The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area. 

(Source: Global News Wire, 2020)