Developments in the Pharmaceutical Outsourcing Industry

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The burgeoning cell therapy and gene therapy market segments continue to spur new partnerships and business expansions for contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) in the second half of 2019.

CombiGene, a gene therapy company located in Sweden, announced it signed an agreement with Cobra Biologics-a CDMO that provides DNA, viral vectors, and microbiota for preclinical, clinical, and commercial supply-for the production of the epilepsy gene therapy candidate drug CG01 (1).

The agreement includes a Master Service Agreement that details the terms under which the two companies will collaborate. There will be three separate contracts: quality, production of plasmids, and production of CG01.The agreement includes manufacturing of CG01 by Cobra for clinical studies and future commercial production, according to a company press release.

In October 2019, Lonza announced an extension to its partnership with Genmab, a Denmark-based biotechnology company specializing in antibody therapeutics for cancer, which covers preclinical and clinical development and manufacturing for part of Genmab’s pipeline (2). Lonza’s Ibex Solutions in Visp, Switzerland can be used for Genmab to take their candidates from gene to investigational new drug applicaton in 12 months and move to reserved manufacturing capacity in Ibex Develop for clinical manufacturing and biologics license application submission. The new agreement will cover development and clinical manufacturing of drug substance and drug product for certain programs in Genmab’s pre-clinical and clinical pipeline.

Lonza also announced it is entering into a manufacturing service agreement with Cellectis, a clinical-stage biopharmaceutical company that specializes in developing immunotherapies based on allogeneic gene-edited chimeric antigen receptor (CAR) T cells (UCART), for the clinical manufacturing of Cellectis’ allogeneic UCART product candidates targeting hematological malignancies (3).

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands where the frozen, off-the-shelf, non-alloreactive engineered CAR T cells will be industrialized with defined pharmaceutical release criteria for the patient population.

Commercial supply agreement

Catalent announced it has entered into a long-term commercial supply agreement with Minerva Neurosciences, a Waltham, MA-based biopharmaceutical company focused on the development of therapies to treat central nervous system disorders (4). The companies will focus on roluperidone (MIN-101), an investigational compound under development by Minerva, for the treatment of negative symptoms of schizophrenia.

A Phase III clinical trial is currently being conducted in Europe and the United States, according to a Sept. 24, 2019 press release. If successful, roluperidone (MIN-101) will be the first treatment approved to treat symptoms of schizophrenia in the US, according to the companies.

References

1. Cobra Biologics, “CombiGene Signs Agreement with Cobra Biologics for Production of Candidate Drug CG01,” Press Release, Oct.r 14, 2019.
2. Lonza, “Lonza’s Ibex™ Solutions to Support Genmab’s Growing Clinical Portfolio,” Press Release, Oct. 14, 2019.
3. Lonza, “Cellectis and Lonza Enter cGMP Manufacturing Service Agreement for Cellectis’ Allogeneic UCART Product Candidates,” Press Release, Oct. 1, 2019.
4. Catalent, “Catalent and Minerva Neurosciences Enter Commercial Supply Agreement for Schizophrenia Drug Roluperidone,” Press Release, Sept. 24, 2019.

Article Details

Pharmaceutical Technology
Vol. 43, No. 11
November 2019
Page: 57

Citation

When referring to this article, please cite it as S. Haigney, "Developments in the Pharmaceutical Outsourcing Industry," Pharmaceutical Technology 43 (11) 2019.