Developments in the Biopharmaceutical Outsourcing Industry

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 October 14, 2019 press release.

“I am very pleased that we have selected Cobra as our manufacturing partner,” said Karin Agerman, chief research and development officer at CombiGene, in the press release. “The choice of a CDMO marks a significant milestone in the CG01 project and an important step towards clinical studies. Our collaboration will now begin in earnest and we see potential for it to continue for many years to come.”

“For almost 20 years, Cobra has been manufacturing DNA and viral vectors for its gene therapy customers and we are pleased to be involved in bringing CG01 closer to market,” added Peter Coleman, CEO at Cobra Biologics, in the press release. “CombiGene has recognized our expertise and track record, and this project fits perfectly into our newly expanded viral-vector manufacturing facility, which will soon be capable of commercial scale supply.”

Also on October 14, 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 is designed to provide Genmab with the flexibility and speed needed to take candidates toward investigational new drug application (IND) filing and commercialization, Lonza reported.

Lonza’s Ibex Design enables Genmab to take their candidates from gene to IND in 12 months and move to reserved manufacturing capacity in Ibex Develop for clinical manufacturing and biologics license application submission. The agreement aims to provide Genmab with security of supply and the ability to move rapidly into clinical manufacturing.

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. These include more complex molecular formats developed using Genmab’s DuoBody technology.

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, according to a October 1, 2019 press release.

“This agreement not only bolsters our product supply for clinical trials, but it ensures that we are producing first-rate product candidates so that we can potentially deliver new hope to patients living with certain blood cancers,” said William Monteith, executive president, technical operations, Cellectis, in the press release.

“We will draw on the experience at our cell and gene therapy center of excellence in the Netherlands, ideally equipped to support Cellectis in bringing their promising pipeline of allogeneic CAR-T therapies to people around the world in need of life-saving products,” added Alberto Santagostino, senior vice-president, head of cell and gene technologies, Lonza, in the press release.

Clinical and commercial contract agreements

Rentschler Biopharma announced in a October 4, 2019 press statement that it will further enhance and develop an existing collaboration in Japan with Summit Pharmaceuticals International Corporation (SPI), a wholly owned subsidiary of Sumitomo Corporation (4). Through its collaboration with SPI, Rentschler Biopharma has secured new contracts with Japanese pharmaceutical companies. SPI and Rentschler Biopharma are working together with Japanese clients to outline projects from early clinical stage up to commercial launch.

“Our relationship with SPI has been highly productive and fruitful, and we have been impressed by their strong network and extensive experience in contract manufacturing and supply. Japanese pharmaceutical companies are playing an important and expanding role in the global healthcare market, and we are delighted to be continuing this productive collaboration as we grow our client base in Japan,” said Frank Mathias, CEO of Rentschler Biopharma, in a company press release.

Catalent announced it has entered into a long-term commercial supply agreement with Minerva Neurosciences, a Waltham, MA, USA-based biopharmaceutical company focused on the development of therapies to treat central nervous system disorders (5). 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 of the drug 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.

“Launching any new drug with a partner marks the culmination of many years of hard work and having to overcome challenges, and is a milestone for a project,” said Aris Gennadios, president, Catalent Softgel & Oral Technologies, in the press release.

“We are pleased to be working closely with our partner, Catalent, under a long-term supply agreement for a compound with the potential to treat negative symptoms, one of the leading unmet needs in schizophrenia,” added Rick Russell, president of Minerva Neurosciences, in the press release.

New facilities and services

Novasep revealed on October 1, 2019 that is has launched a dedicated unit in Seneffe, Belgium that offers fill/finish clinical and commercial services for biological products (6). The unit, Senefill, forms part of Novasep’s flagship for the manufacturing of commercial viral vectors, Senrise-IV, and will provide standalone fill/finish services in addition to integrated drug product manufacturing, ranging from formulation to packaging. Operations undertaken at Senefill will support Novasep’s key biopharmaceutical markets.

“Senefill is a major step for Novasep to achieve its growth strategy, Rise-2,” said Michel Spagnol, chairman and CEO of Novasep, in a press release. “This unit strongly distinguishes Novasep from its competitors in the market for viral-vector drug product manufacturing services. It was crucial for us to be able to meet the growing needs of our clients for targeted and innovative therapies and address patients’ needs.”

References

1. Cobra Biologics, “CombiGene Signs Agreement with Cobra Biologics for Production of Candidate Drug CG01,” Press Release, October 14, 2019.
2. Lonza, “Lonza’s Ibex™ Solutions to Support Genmab’s Growing Clinical Portfolio,” Press Release, October 14, 2019.
3. Lonza, “Cellectis and Lonza Enter cGMP Manufacturing Service Agreement for Cellectis’ Allogeneic UCART Product Candidates,” Press Release, October 1, 2019.
4. Rentschler Biopharma, “Rentschler Biopharma Announces Enhanced Collaboration with Summit Pharmaceuticals International Corporation to Expand Japanese Operation-Base,” Press Release, October 4, 2019.
5. Catalent, “Catalent and Minerva Neurosciences Enter Commercial Supply Agreement for Schizophrenia Drug Roluperidone,” Press Release, Sept. 24, 2019.
6. Novasep, “Senefill, Novasep’s Commercial Facility for Aseptic Filling and Finishing Operations, Is Now Ready to Operate,” Press Release, October 1, 2019.

Article Details

BioPharm International
Vol. 32, No. 11
November 2019
Pages: 10-12

Citation

When referring to this article, please cite it as S. Haigney, "Developments in the Biopharmaceutical Outsourcing Industry," BioPharm International 32 (11) 2019.