Pharmaceutical Technology Editors

 on July 2, 2021, that the agency’s committee for human medicines (CHMP) has approved scale-up of API manufacturing at the Janssen Biologics B.V. plant located in Leiden, the Netherlands. The plant produces all API for Janssen’s COVID-19 vaccine supply in the European Union and is expected to continue to supply the vaccine for the EU.

The scale up of the facility includes a new building, new equipment, and additional process optimizations. The approved modifications are anticipated to increase API manufacturing capacity. EMA states that the recommendation does not require a decision from the European Commission; therefore, the new building can immediately become operational.

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The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine

FDA authorized an additional batch of Janssen’s COVID-19 vaccine manufactured at Emergent BioSolutions’ facility in Baltimore under Emergency Use Authorization (EUA), the agency announced on July 2, 2021.

Thus far, four batches have been authorized to be manufactured at the Emergent BioSolutions plant in the Janssen EUA, though the facility isn’t officially an authorized manufacturing facility. FDA reviewed facility records, including quality testing, and concluded the batches were suitable for use.

FDA said it will continue to work through issues that arise at the Emergent facility with Janssen and Emergent BioSolutions management.

 the use of two batches of Janssen’s vaccine under EUA on June 11, 2021.

An additional batch of the Janssen COVID-19 vaccine has been authorized by FDA under the Emergency Use Authorization.

FDA Authorizes Additional Batch of the J&J COVID-19 Vaccine

On June 29, 2021, Cytiva announced that it has acquired Intermountain Life Sciences, a manufacturer of high-purity water, buffers, and liquid cell culture media. Through the acquisition, Cytiva will use Intermountain’s manufacturing site in Logan, Utah to rapidly boost its liquid cell culture production by millions of liters.

Intermountain’s Logan site is fully functional and running efficiently, and Cytiva intends to build on that momentum to ramp up production through hiring. The site and its capabilities will become part of Cytiva’s cell culture media portfolio.

“The demand for buffers and cell culture media has grown substantially in recent years thanks to their use in gene therapies, as well as their use in making COVID-19 vaccines and therapies. Adding the capacity and talent from Intermountain Life Sciences will allow us to accelerate deliveries to our customers,” said Olivier Loeillot, vice-president, Cytiva, in a company press release. “We’re really impressed with the quality practices that we see, and we’ll be bringing dozens of people on board to build on the work already being done at the site.”

“At Intermountain, we aim to be an innovative, responsive, and quality-driven outsourcing partner to the biotechnology industry. As part of Cytiva, we’ll continue on this mission at a larger scale,” said Russ Wilcox, president of Intermountain, in the press release.

The acquisition of Intermountain Life Sciences will double Cytiva’s capacity for buffers and liquid cell culture media at its manufacturing site in Logan, Utah.

Cytiva Acquires Intermountain Life Sciences

Pinteon Therapeutics, a biotechnology company, and Lonza announced on June 24, 2021 that they have expanded their manufacturing agreement to enable future clinical production of Pinteon's lead candidate, PNT001, which has shown promising results in a Phase I clinical study.

This extension follows the multi-year manufacturing relationship between the companies established in Lonza's Slough, UK, site in 2018, which was to provide drug substance (DS) manufacturing for Phase I clinical supply. Starting in the fourth quarter of 2021, PNT001 current good manufacturing practice (CGMP) DS will be manufactured in Lonza's new CGMP mammalian facility in Guangzhou, China, which will enable Pinteon to conduct clinical trials in the United States with potential future expansion into Europe.

PNT001 is a monoclonal antibody that targets cis-pT231 tau, an epitope on a highly neurotoxic conformation of the tau protein. This conformation of tau is acutely neurotoxic and also contributes to the initiation and spread of tau pathology in neurodegenerative tauopathies, such as traumatic brain injury, chronic traumatic encephalopathy, Alzheimer's disease, and progressive supranuclear palsy, the companies stated in a press release.

PNT001 is currently being studied in a Phase I trial for treating acute traumatic brain injury. Pinteon expects to initiate a Phase Ib/Phase II study in patients with Alzheimer's disease by the end of 2021.

"We look forward to building upon a strong relationship with Pinteon to help advance their innovative tau antibody therapy towards commercialization. This collaboration highlights our flexibility and commitment to providing high-quality manufacturing to serve the clinical needs of our global customers while also leveraging our cGMP manufacturing expertise at our Guangzhou, [China] site," said Jennifer Cannon, senior vice-president, global head of Mammalian Biologics, Lonza, in the press release.

"We have been working with Lonza since 2017 and appreciate their flexibility in responding to our needs. This agreement is exciting because it ensures sufficient clinical supply as we look to rapidly advance PNT001, a novel tau antibody that uniquely targets a toxic epitope known to drive neurodegenerative disease," said Martin Jefson, CEO, Pinteon, in the press release.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Pinteon and Lonza Extend Collaboration for Manufacturing Antibody Therapeutic

On June 29, 2021, Selexis and KBI Biopharma (KBI), both JSR Life Sciences companies, announced that they signed service agreements with Immatics, a clinical-stage biopharmaceutical company specializing in T-cell redirecting cancer immunotherapies, to use integrated services from Selexis and KBI to advance the development of IMA402, one of the candidates in Immatics’ T-cell receptor (TCR) bispecifics program, called T Cell Engaging Receptors (TCER). The program involves using TCR bispecifics that simultaneously recruit, activate, and stimulate the patient’s own T cells to detect, target, and attack tumor cells.

Under the agreements, Selexis will use its SUREtechnology Platform, and KBI will leverage its advanced analytics, process, formulation, and current good manufacturing practice (cGMP) manufacturing to advance IMA402 to the investigational new drug (IND) stage.

Immatics is developing TCR-based immunotherapies with an emphasis on solid tumors through two therapeutic modalities: adoptive cell therapies (ACTengine) and antibody-like TCR Bispecifics (TCER). Because of their different modes of action, these modalities are designed to expand the therapeutic value for patients across a broad range of tumor types and stages.

“Immatics is pushing beyond the limitations of traditional antibody-based therapies by investigating targets beyond the cell surface to treat solid tumors,” said Dirk Lange, CEO at Selexis and president and CEO at KBI Biopharma, in a company press release. “The integrated workflow between Selexis’ SUREtechnology Platform and KBI’s development approach and cGMP [m]anufacturing is designed to rapidly advance complex, novel product candidates towards [IND] submissions, while also providing a strong foundation for subsequent late-stage development and commercialization. We’re excited to work with Immatics as the company advances its TCR Bispecific candidate IMA402 towards the clinic.”

“Having delivered preclinical proof-of-concept for our TCR Bispecifics program IMA402 and having moved this program into GMP process development is a major achievement of Immatics,” said Sven Berger, CMC Project leader at Immatics, in the press release.

“We have chosen Selexis and KBI because of their expertise in the development and manufacturing of bispecific antibodies. We are looking forward to working with them on our path towards IND for IMA402,” added Michael Mølhøj, head of CMC Biologics at Immatics, in the press release.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

Selexis and KBI Biopharma Partner with Immatics to Advance T-Cell Bispecific Program

Catalent announced on June 24, 2021 an agreement to acquire RheinCell Therapeutics GmbH, a Langenfeld, Germany-based developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs), further expanding its custom cell therapy process development and manufacturing capabilities.

In making the announcement, Catalent reported that the acquisition will allow it to offer the building blocks to scale iPSC-based cell therapies and reduce barriers to entry to the clinic for therapeutic companies.

iPSC cell types can address a number of therapeutic indications. RheinCell has researched and developed full GMP human leukocyte antigen-matched cell banks.

Upon closing, which is expected before the end of 2021, RheinCell’s current employees will join Catalent’s Cell & Gene Therapy business.

Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs. 