Monday, March 9, 2020 Daily Archives

Trouble choosing? BrevisRefero launches CDMO proposal platform

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BrevisRefero has launched a Request For Proposal (RFP) platform aimed at helping biopharma better select its third-party manufacturing partners. The pharma world has for years relied on outsourcing partners. Contract research organizations (CROs) are used to carry out clinical trials, third parties manage transport and logistics, and of course contract development and manufacturing organizations (CDMOs) support production of nearly every component of the drug production process. Now the biopharma space can outsource the outsourcing process itself, through an online RFP…

March 9, 2020

Samsung Bio lands MAb development contract with STCube

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Samsung Biologics has landed another development project when STCube asked it to help it with a cancer monoclonal antibody candidate. The South Korean contract development and manufacturing organization (CDMO) will provide cell line and process development services. It will also manufacture material for preclinical development and human trials. The monoclonal antibody in question targets an unspecified protein – called STT-003 by STCube – that is found on the surfaces of cancer cells. According to STCube, because cancer cells express high…

March 9, 2020

Individualized gene therapy: FDA considering device-like manufacturing approval process

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CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed. Individualized gene therapy approvals at the US Food and Drug Administration (FDA) could speed up using a 510(k)-like process under consideration. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said the FDA needs a workable pathway not requiring new authority from Congress to deal with the growing sector. During…

March 9, 2020