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On May 6, 2021, Lonza announced that it will be making significant investments to expand its mammalian drug substance manufacturing facilities in Visp, Switzerland, and Portsmouth, NH, in the United States. The company plans to spend CHF 850 million (US$936 million) in the expansions.

In Visp, the company plans to build a new large-scale mammalian drug substance manufacturing facility that will add six 20,000-L bioreactors to meet increasing market demand for biologics. This new high-throughput facility will have an area of approximately 27,500 m2 and will include perfusion capabilities while optimizing energy efficiency and water use. It will be designed to support high titer processes and will have the capability to accommodate the next generation of mammalian biologics, Lonza stated in a company press release.

The new Visp facility is expected to be completed in 2024 and will account for approximately CHF 650 million (US$715 million) of the total investment. The Visp expansion will complement the company’s existing large-scale global network at Portsmouth as well as its sites in Tuas, Singapore, and Porriño, Spain.

In Portsmouth, the company plans to build a next-generation facility to support late-phase clinical and commercial development and manufacturing. This facility will add capacity for up to eight 2000-L single-use bioreactors over an area of 3000 m2. The Portsmouth expansion will account for the remaining CHF 200 million (US$220 million) of the total investment. This expansion will help meet increasing market demand for small- to mid-scale mammalian-derived biologics and will support the implementation of high titer and high throughput platform processes, the company also stated in its press release. The new Portsmouth facility, expected to be completed in 2023, will be designed to support Phase III clinical and commercial small- to mid-volume products and will include state-of-the-art technologies in perfusion, purification, and automation. The facility will complement the existing single-use network at Lonza’s sites in Tuas and Visp as well as in Hayward, CA, and Slough, UK.

Lonza has already begun recruitment for both new facilities, which will create more than 300 new jobs in Visp and 250 new positions in Portsmouth.

“As we look at the biologics market, we see a combination of growth at pace coupled with continuing high customer demand. In recent months, the COVID-19 pandemic has placed the spotlight on supply chains and the critical role CDMOs [contract development and manufacturing organizations] play in ensuring an adequate supply of medicines. The expansion of both our large-scale and small-scale manufacturing capacity will ensure Lonza continues to deliver industry-leading contract manufacturing services that will support our customers’ needs in the medium and long term,” said Pierre-Alain Ruffieux, CEO of Lonza, in the company press release.

“At Lonza, we are focused on supporting our customers to achieve efficient, high-throughput production processes and flexible manufacturing solutions. Our customers’ needs range from the manufacture of small- to mid-volume products, such as innovative pharmaceuticals for rare diseases affecting smaller patient populations, to the large-scale commercial production of biologics. These expansions serve to strengthen our position as a critical partner in the development and manufacture of such medicines,” added Jean-Christophe Hyvert, president, Biologics and Cell & Gene, Lonza, in the press release.

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Lonza plans to invest approximately CHF 850 million (US$936 million) to build new state-of-the-art mammalian manufacturing facilities at its Visp, Switzerland, and Portsmouth, NH, sites.

Lonza to Expand Sites with Next-Generation Mammalian Manufacturing Facilities

Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine, Sanofi announced on May 6, 2021. The two organizations and their scientists will work together to advance the understanding of immunology and inflammation through open scientific exchange. Sanofi will additionally provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas, including autoimmune diseases and inflammatory conditions.

Under the collaboration, Sanofi and Stanford Medicine will create a joint steering committee to fund up to three programs per year. Sanofi will host an annual research forum for researchers from both organizations with the goal of further exchanging ideas, sharing knowledge and perspectives on relevant scientific matters, and discussing collaborative research projects.

The collaboration will begin with three "deep-dive" research projects:

Exploring cytokine crosstalk in type 2 inflammation—this project will specifically examine the impact of Sanofi’s investigational molecules on excessive type 2 inflammation.

Decoding molecular drivers of effector and suppressor T cells in autoimmunity—the goal of this project is to better understand the specific antigens that may cause type 1 diabetes.

Defining the mechanisms of immune-related adverse events with immune checkpoint inhibitor therapy—this project will focus on pneumonitis and inflammatory arthritis, exploring the role of genomics and pathogenic cell identification.

“We look forward to working with some of the most innovative scientists in the human immunology community. Together we will explore groundbreaking concepts and obtain deeper insights into underlying inflammatory disease mechanisms,” said Frank Nestle, global head of Research and chief scientific officer, Sanofi, in the company press release. "Sanofi’s collaboration with Stanford University aims to transform how autoimmune disorders and inflammatory conditions are understood and treated. It will help accelerate our ambitious immunoscience programs as we advance a rich pipeline of first- and best-in-class medicines across key therapeutic areas to address unmet patient needs.”

“Stanford Medicine is dedicated to advancing knowledge and discovery with the goal of improving our ability to predict, prevent, and cure disease with the most precise approaches,” said Lloyd Minor, MD, dean of the Stanford School of Medicine, in the press release. “The opportunity for long-term collaboration with our colleagues at Sanofi will allow us to explore together new frontiers in autoimmune diseases and inflammatory conditions.”

Projects led by collaborating researchers from both Sanofi and Stanford Medicine will focus on autoimmune diseases and inflammatory conditions.

Sanofi Forms Three-Year Immunology Research Collaboration with Stanford Medicine

On May 6, 2021, Eli Lilly and Company (Lilly) announced that it has signed strategic international agreements with four diabetes technology companies—DexCom, Glooko, myDiabby Healthcare, and Roche—to integrate data and technology in a bid to streamline diabetes management in markets outside the United States. These companies offer unique diabetes management platforms that are compatible with Lilly's Tempo Pen (approved in several global markets) and Tempo Smart Button (currently in late-stage development).

Tempo Pen is a modified version of Lilly's existing prefilled, disposable insulin pen. The Tempo Smart Button is designed to attach to the Tempo Pen and is pending Conformité Européenne (or European Conformity) (CE) marking. Lilly said it aims to receive CE mark for the Tempo Smart Button later in 2021 and will launch the Tempo Pen and Tempo Smart Button in several international markets following this certification.

Through Lilly’s new agreements, the Tempo Smart Button will pair with software and/or medical devices offered by Dexcom, Glooko, myDiabby Healthcare, and Roche, via Lilly’s mySugr app. This pairing is expected to facilitate the integration of personalized data and actionable insights, Lilly stated in a company press release.

"We're pleased to work alongside these innovative partners who share our commitment to improving diabetes outcomes by bringing together medicine and digital solutions for the global diabetes community," said Marie Schiller, vice-president of product development for Connected Care and Insulins at Lilly, in the press release. "Insulin dose logging is often an incomplete piece of the diabetes management puzzle for people who use insulin pens and manually track their doses. By integrating data from the connected insulin pen solutions into widely used compatible software, including potential future collaborations, we aim to support improved decision-making for people with diabetes and their healthcare providers with accurate, real-time data collection. These solutions may also help address psychological barriers like fear of hypoglycemia that may negatively impact diabetes management."

"People with diabetes need access to all of the key information about their condition. For those who use insulin pens, tracking how much insulin they delivered and the time of the dose and bringing that information together with glucose data can help them meaningfully improve their management," said Tadej Battelino, head of Endocrinology, Diabetes & Metabolism, UCH professor, at the University of Ljubljana, in the press release. "These agreements mark a meaningful step towards providing useful tools that help provide real-time guidance and holistic support to ease some of the burdens of living with diabetes."

Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.

Lilly Forms Pact with Diabetes Tech Companies to Integrate Connected Insulin Pen Solutions

On May 5, 2021, GlaxoSmithKline (GSK) announced that the European Commission (EC) approved the expanded use of intravenous (IV) and subcutaneous (SC) Benlysta (belimumab), in combination with background immunosuppressive therapies, for treating active lupus nephritis (LN) in adults in Europe, in addition to systemic lupus erythematosus (SLE). This marketing authorization follows the recent approval for the similar expanded LN indication in the United States, GSK stated in a company press release.

The marketing authorization application was based on data from a study that showed belimumab, over two years, added to increased renal response rates with standard therapy and helped to prevent worsening of kidney disease in patients with active LN compared to standard therapy alone.

Benlysta is a BLyS-specific inhibitor human monoclonal antibody (mAb) that binds to soluble BLyS. By binding BLyS, the mAb inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Belimumab was first approved in the European Union in July 2011 for use as an add-on IV therapy in adults with SLE and as a SC formulation in November 2017. The SLE indication was extended for the use in children for the IV formulation in October 2019.

“Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than [one] million patients worldwide. Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease,” said Hal Barron, chief scientific officer and president R&D, GSK, in the press release.

“In the [study], the addition of Benlysta to standard therapy resulted in a 49% decrease in risk to patients of experiencing a renal-related event as well as a significantly higher number of study participants reaching the PERR [prior event rate ratio]. I’m encouraged that progress is being made for people with lupus nephritis as we work toward the overarching goal to delay the need for kidney replacement therapies, such as dialysis and transplantation,” said Y.K.O. (Onno) Teng, MD, PhD, Nephrology clinician-scientist at the Department of Internal Medicine of the Leiden University Medical Center, The Netherlands, in the press release.

“This achievement is derived from decades of research. For years, we have not been able to achieve remission for more than one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the [study] show that Benlysta added to standard therapy in management of active lupus nephritis may lead to improved long-term outcomes for patients by both increasing response rates and delaying further kidney disease progression,” added Richard Furie, chief of the Division of Rheumatology and professor at the Feinstein Institutes for Medical Research at Northwell Health, and lead investigator of the study, in the press release.

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

EC approves GSK’s Benlysta for Adults with Active Lupus Nephritis

Roche announced on May 5, 2021 that the European Commission (EC) has approved Tecentriq (atezolizumab) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high programmed death-ligand 1 (PD-L1) expression and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The approval makes Tecentriq the first and only single-agent cancer immunotherapy with three dosing options (two weeks, three weeks, or four weeks), allowing for greater flexibility in managing the disease, according to a Roche press release.

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets globally. The biologic now has four approved indications in NSCLC in Europe, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).

Tecentriq is approved in the United States, European Union (EU), and countries around the world either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer, and for hepatocellular carcinoma. In the US, the therapy is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in the company press release. “Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.”

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

EC Approves Additional Indication for Roche’s Tecentriq in Lung Cancer Treatment

Sandoz, a Novartis division, announced on May 3, 2021 that it is progressing into late-stage clinical development for its proposed biosimilar aflibercept (brand name EYLEA under Regeneron Pharmaceuticals). Sandoz will soon begin enrolling the first patient in a clinical Phase III confirmatory efficacy and safety study, the company stated in a press release.

Aflibercept is indicated to improve visual acuity in patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other specific neovascular retinal diseases.

“nAMD accounts for 10% of all age-related macular degeneration cases but is responsible for 90% of AMD-related blindness,” said Florian Bieber, global head of Biopharmaceuticals Development, Sandoz, in the press release. “Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. As with all our biosimilar programs, we aim to expand access to high-quality, more affordable biologics.”

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

In a May 3, 2021 press release, the agency revealed that its Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data submitted by the company that markets Comirnaty. The data includes results from a large ongoing clinical study that involves adolescents from 12 years of age.

Any decision made by CHMP will be submitted to the European Commission, which will issue a final legally binding decision for the European Union. EMA will provide further information on the evaluation as it becomes available, which is expected to be in June should no additional information be required.

Accelerated Assessment of Comirnaty in Young People Commences

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

According to a May 4, 2021 press release, CHMP’s decision to start the rolling review has been based on preliminary results from laboratory studies and clinical studies, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2. All data will be evaluated by EMA as it becomes available on a rolling basis and will continue until sufficient evidence is available for a formal marketing authorization application.

Compliance of Vero Cell will be assessed by EMA, according to the usual European Union standards for effectiveness, safety, and quality. Further communications will be published by EMA when the marketing authorization application for the vaccine has been submitted.

The EU applicant for the medicine is Life’On S.r.l.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences. 

EMA’s CHMP Starts Rolling Review of Inactivated COVID-19 Vaccine

Merck, known as MSD outside of the United States and Canada, announced on May 5, 2021 that FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval was based on positive data from the ongoing Phase III KEYNOTE-811 trial, where patients who received trastuzumab with Keytruda had a complete response rate of 11% and a partial response rate of 63%, while patients who received trastuzumab and chemotherapy alone had a complete response rate of 3.1% and a partial response rate of 49%, Merck said in a company press release.

“Today’s approval marks an important milestone, as this is the first time an anti-PD-1 therapy has been approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients,” said Dr. Roy Baynes, senior vice-president and head of global clinical development, chief medical officer, Merck Research Laboratories, in the press release. “From the start of Keytruda’s development, we have thoughtfully pursued novel combinations to help more patients with cancer. We are pleased to bring a new first-line combination regimen with Keytruda that has shown meaningful improvement in ORR (objective response rate) over standard treatment to patients with HER2-positive gastric and GEJ cancer.”

FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Merck’s Keytruda Approved in Combination with Trastuzumab and Chemotherapy for Cancer Treatment

 Washington Editor, jillwechsler7@gmail.com.

against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website. 

 warns Acceleron Pharma that it faces a $10,000 penalty if it continues to ignore requirements to disclose summary results information related to a study done years ago for a combination cancer treatment.

The FDA notice marks the first time the agency has publicly threatened fines and possible criminal prosecution for such a violation since the clinical trial disclosure rule went into effect in 2017. FDA 

 on how sponsors should meet the disclosure requirements and what action it will take with entities that fail to comply. The guidance explains that FDA will first send the sponsor a pre-notice of noncompliance, which allows 30 days for voluntary action. That would be followed by a final notice allowing another 30 days before levying penalties, as has occurred now with Acceleron. Although the company has published articles on this Phase II study of dalantercept with axitinib for patients with advanced renal cell carcinoma, which turned out to be unsuccessful, the company failed to post results on the ClinicalTrials.gov website managed by the National Library of Medicine at the National Institutes of Health (NIH).

FDA emphasizes that it encourages voluntary compliance with requirements for registering clinical trials for drugs, biological products, and medical devices on the ClinicalTrials.gov website and for submitting required summary results to the clinical trials data bank no later than one year after study completion date. To enforce this policy, FDA now has sent more than 40 pre-notices of noncompliance as part of the agency’s effort to promote greater transparency related to clinical trials and to allow the broader scientific community to access and build on the submitted data. The overarching goal is to enhance public support and participation in the clinical research process.

While continuing to urge sponsors to meet the disclosure policy voluntarily, Acting Commissioner Janet Woodcock stated that FDA takes enforcement of the clinical trials registration and results information requirement “extremely seriously.” FDA will take “appropriate actions,” Woodcock said, to ensure that required information in available “for the benefit of clinical trial participants and public health.”

Advocates for greater transparency in clinical research applauded FDA’s action, but still harped that it was too slow in enforcing penalties for delayed disclosure, which some analysts regard as widespread among researchers. Sponsors have appeared most reluctant to post study outcomes data for failed clinical trials, as was the case for the Acceleron therapy, partly to avoid acknowledging research disappointments.

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

 FDA Gets Tough on Sponsors Not Reporting Clinical Trial Results 

As pressure mounts on Capitol Hill to enact legislation designed to reduce federal outlays for prescription drugs, the drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic. In a surprise move, the Biden administration has announced support for waiving international protections on intellectual property (IP) under the World Trade Organization (WTO) to expand access to COVID-19 vaccines. US Trade Representative Katherine Tai 

stated that a limited waiver on IP protections for certain products would be negotiated by WTO

 to help end the worldwide pandemic and block the emergence of new viral variants.

Biopharma leaders countered that even with patent waivers, the new vaccines will be difficult for foreign manufacturers to produce quickly and safely [see note below]. Instead, US and European manufacturers seek to maintain IP protections by ramping up vaccine donations and supplies of production materials for India and other countries with capable vaccine production facilities to increase local production. Moderna recently promised to send 500 million doses of its COVID vaccine to COVAX, the vaccine supply program for the World Health Organization (WHO), while Pfizer earlier donated $70 million in medicines to India to help treat the surge in coronavirus infections and deaths. Moderna had previously said that it would not enforce IP protections for its mRNA-based vaccine, but that has not led to new production overseas. And AstraZeneca and Johnson & Johnson already have licensed their vaccines to foreign manufacturers.

Industry’s main message is that patents drive biomedical innovation, which has been responsible this past year for remarkably fast action in developing new vaccines and treatments to combat COVID-19. Loss of IP protection would open the door to drug developers in China and Russia to tap confidential information held by western firms and would do little to help manufacturers in developing nations move into vaccine production.

Meanwhile, Congressional leaders are proposing legislation to drive down drug costs at home to finance expanded social and educational benefits under the Biden administration’s American Families Plan. So far, the White House appears willing for Congress to take the lead on the drug pricing debate, with President Biden omitting specific price reform provisions from this latest legislative package.

The main arguments for and against drug pricing proposals were aired at recent hearings before 

subcommittees representatives, consumer advocates, financial analysts, and leading academics made their cases for legislative proposals to shape drug development and patient care; reformers claimed that costly therapies limit patient access to life-saving treatments, while heavy spending on medicines drives up health care costs for all. Industry analysts maintained that the free market for medicines in the United States benefits all by supporting hefty investment in high-risk biomedical R&D. They argue that actual drug prices are tricky to assess; patient out-of-pocket costs are driven more by hospitals and insurance practices; and greatly expanding competition from Chinese and other subsidized manufacturers is challenging innovation in the US and Europe.

The lead House proposal, HR 3, seeks to authorize price negotiations for drugs reimbursed by Medicare Part D drug plans. While that move is strongly opposed by industry, there’s more bipartisan support for limits on annual drug price hikes, caps on out-of-pocket costs for patients, added price transparency, and revisions in drug reimbursement for treatments delivered in clinics under Medicare Part B.

Senate leaders also are looking to revise earlier pharma pricing measures to gain sufficient support from Republicans to move forward. Earlier legislative efforts by the Senate Finance Committee were blocked by the GOP leadership, and moderates could still shy away from proposals strongly opposed by industry and certain patient groups.

Meanwhile, Democrats disagree on how the administration should use the savings generated by drug price reductions. Moderates look for added revenues to strengthen coverage under the Affordable Care Act and to bolster biomedical research and drug oversight. Progressive reformers, however, want to use the gains to expand Medicare and Medicaid as next steps towards a universal healthcare system.

Up until now, the White House had signaled that it wants to avoid a major confrontation with the biopharmaceutical industry, which has earned plaudits for record development and production of critical COVID vaccines and therapies. President Biden recently signed into law two bills designed to enhance approval of new generic drugs and to encourage prescribing of biosimilars, and other more targeted reform measures may gain support if broader pricing measures fall off.

At the same time, financial reports reveal huge increases in revenues and profits for the makers of pandemic vaccines and therapies. Pfizer recently predicted $26 billion in COVID-19 vaccine sales this year, likely its biggest source of revenue. Analysts also are documenting a broad increase in global spending on drugs and vaccines last year, and the rise is projected to continue. A WTO resolution waiving IP protections only for COVID-19 vaccines in itself is unlikely to erode sales for existing products, as it is expected to take weeks or months to negotiate. The larger danger is that it could set a precedent for similar action on treatments for other critical diseases and further encourage political attacks on pharma operations and profits.

Note: the complexities of mRNA-based vaccine production are clearly illustrated by the New York Times article on Pfizer’s vaccine process:see 

How Pfizer Makes Its Covid-19 Vaccine - The New York Times (nytimes.com)

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

Pharma Prices and Patents Under Attack

Catalent announced on May 6, 2021 that it has acquired therapy development company Promethera Biosciences’ cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 ft2 facility in Gosselies, Belgium.

Under the terms of the agreement, the new facility will provide space for Catalent’s commercial-scale plasmid DNA (pDNA) manufacturing and service offering, Catalent said in a company press release. The facility also features an existing cleanroom infrastructure, process development and quality control laboratories, and warehouse space.

“Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA (messenger RNA), and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP [current good manufacturing practice] commercial production, offering the full horizontal supply chain,” said Manja Boerman, PhD, president, Catalent Cell & Gene Therapy, in the press release. “The Center of Excellence we have established in Belgium brings critical experience and expertise together on one campus, allowing for key synergies to best support our customers.”

“Promethera is thrilled to divest its HCTS facility to Catalent, alongside its new strategy to concentrate activities on its core expertise and breakthrough approach using advanced therapies to restore liver health in patients with life-threatening liver diseases,” added Professor Etienne Sokal, president of Promethera, in the press release.

Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.

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