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Eli Lilly partners with Samsung Biologics to improve COVID-19 antibody manufacturing efforts.

Eli Lilly recently announced that it would be partnering with Samsung Biologics to accelerate the manufacturing of its COVID-19 antibodies.

The candidate antibody, bamlanivimab recently, received U.S Food and Drug Administration’s (FDA) authorization for emergency use just the week before.

Both companies entered an initial manufacturing partnership back in May, and, since then, Samsung Biologics have already manufactured the first batch of active pharmaceutical ingredients despite the difficulties in obtaining raw materials.

Eli Lilly hopes to deliver over 1 million doses of the antibodies in 2021.

(Source: Fierce Pharma, 2020)

Omeros Corporation Submits its Biologics License Application to U.S. FDA. 

Omeros Corporation recently announced that it has completed the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement.

This BLA submission, comprising clinical sections, follows the previously submitted chemistry, manufacturing, and controls (CMC) and nonclinical sections, which are under review by the FDA.

The clinical sections are based on previously reported results of the pivotal trial of narsoplimab in HSCT-TMA in which the drug met its primary endpoint and demonstrated a similarly strong response across its secondary endpoints.

(Source: Business Wire, 2020)

ThermoFisher establishes a new facility in China to meet Biologics demand.

Thermo Fisher Scientific recently announced that it will establish a new facility for integrated biologics and sterile drug development and manufacturing in Hangzhou, China.

Thermo Fisher has signed a joint venture agreement with China-based Innoforce Pharmaceuticals to establish the new facility in Hangzhou just this month.

Innoforce will support Thermo Fisher to meet the high biologics demand in China.

The new facility which is expected to be completed by 2022, includes strict quality management procedures that either meet or exceed the regulatory guidelines defined by the China National Medical Products Administration (NMPA), the US Food and Drug Administration (FDA), and European Medicines Agency (EMEA).

(Source: Pharmaceutical – Technology, 2020)