Samsung Biologics strikes manufacturing and development deal with Kurma

Samsung Biologics will provide Kurma Partners’ portfolio companies with manufacturing, development, and de-risking services for biologics.

Contract development manufacturing organization (CDMO) Samsung Biologics has entered into a multi-year agreement with European venture capital firm Kurma. While no financial details of the deal have been disclosed, Samsung Biologics will provide chemistry, manufacturing, and control (CMC) development services for Kurma’s portfolio companies to streamline Investigational New Drug (IND) processes.

In addition, the partnership aims to de-risk uncertainties in CMC and advance the selection of lead candidates into clinical studies and clinical development. According to the CDMO, the strategic partnership also increases its presence in the US and European markets.

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“As we look to further expand our business opportunities globally, we are pleased to collaborate with Kurma Partners to support the growth of pioneering biotech companies,” said John Rim, CEO of Samsung Biologics.

“With our in-depth knowledge on effective scale-up strategy and a diverse portfolio of proprietary platform technologies, we are looking forward to providing robust CMC solutions to reduce uncertainties, ensure regulatory compliance, and ultimately maximize manufacturing efficiency for our clients.”

Furthermore, Kurma said the collaboration will benefit its portfolio through advancing large molecule biologics from the clinic through to commercialization.

In the same week as this deal was announced, an inspection of Samsung Biologics’ site in Incheon, South Korea by the US Food and Drug Administration (FDA) resulted in a Form 483 with six observations.

Within the Form, the FDA criticized Samsung Biologics’ written controls procedures, as well as the failure of the CDMO to establish controls over manufacturing operations and process.

The Agency also said the firm failed to perform revalidation of drug product equipment at appropriate intervals, had an inadequate Quality Unit, and had not adequately maintained its facilities. Specifically, the FDA noted a ceiling port dislodged, a broken door leading to the outside within a GMP warehouse, and a deteriorated sealant between floor and wall in one of the plant’s preparation rooms.