Pharmaceutical Technology Editors

Lonza and Agilent announced a strategic collaboration to incorporate new analytical technologies into Lonza’s Cocoon platform technology on Dec. 15, 2021. By incorporating analytical technology into Cocoon, an automated and closed platform for patient-scale cell therapy manufacturing, the companies hope to ensure consistent product quality.

According to a Lonza press release, product quality and consistency are difficult to maintain in cell therapy manufacturing due to product complexity and patient-specific variability. Additionally, minor manufacturing changes can result in major effects to quality and efficacy, making in-process controls and analytics critical in ensuring consistency.

To remedy this, Lonza plans to integrate Agilent’s analytics technologies and techniques into the Cocoon platform. These in-process controls and analytics will help provide real-time information on critical quality attributes (CQAs), with the ultimate goal of defining the ideal CQAs required for cell therapies.

“The integration of Agilent’s analytical technologies into the Cocoon [platform’s] manufacturing workflow has the potential to transform the way cell therapies are manufactured and released,” said Nicholas Ostrout, senior director, Business Strategy & Implementation, Personalized Medicine, Lonza, in the press release. “The collaboration with Agilent is complementary to our long-term goals for the Cocoon [platform] and we are excited about this synergistic relationship. There is a huge opportunity through this partnership to determine what the ideal critical quality attributes are for manufacturing the most effective cell therapy, and drive the manufacturing, optimally in real-time, to meet those criteria.”

“Merging Agilent’s unique cell analytics and engineering expertise with Lonza’s advanced biologics manufacturing capabilities will ensure the efficacious and sustainable development of autologous cell-based therapies,” said David Ferrick, associate vice-president, New Market Development, Cell Analysis Division, Agilent, in the press release. “This timely combination is well positioned to deliver the first fit-for-purpose solution for scaled manufacturing of autologous cell therapies.”

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Lonza plans to ensure consistent product quality by incorporating Agilent’s analytics technology into its Cocoon platform.

Lonza to Incorporate Agilent Analytics Technology Into Cocoon Platform

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands is now open and fully operational, the company announced on Dec. 8, 2021. The new facility provides life science manufacturing and, with the company’s other manufacturing locations in the United States and Japan, increases production capacity of cell culture media products. The Tilburg site acts as a hub for both European and global markets.

The Tilburg site is the third manufacturing facility in FUJIFILM Irvine Scientific’s roster and represents an important step in the company’s long-term plans to secure its production capacity to meet growing market demand. The facility’s location in central Europe makes it a source of local supply, increasing supply chain efficiency and enabling cost-savings in shipping.

The facility was built on sustainable initiatives following the parent company’s Fujifilm Sustainability Value Plan 2030. Strategies in use at the new facility include working towards a carbon dioxide-neutral status, using wind energy for production process, and using sustainable technologies. such as membrane bioreactors, for wastewater purification.

The Tilburg facility uses approximately 13,500 m2 of space and manufactures dry powder media, liquid media, buffers, and water for injection. The facility initially increases the company’s production capacity with approximately 320,000 kg/year of dry powder media and greater than 470,000 L/year of liquids. The company can also expand rapidly if the necessity arises.

“We worked steadily to achieve milestones for construction, validation, and commissioning of this manufacturing facility,” said Yutaka Yamaguchi, chairman and CEO, FUJIFILM Irvine Scientific, in a company press release. “Even with the global challenges faced in recent years, FUJIFILM Irvine Scientific was determined to provide customers in Europe with local service that strengthens the supply chain and increases manufacturing capacity. It is extremely rewarding to see this commitment realized.”

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.

FUJIFILM Irvine Scientific Opens New European Manufacturing Facility

FUJIFILM Diosynth Biotechnologies announced on Dec. 2, 2021 that it plans to invest £400 million (US$528 million) into expanding its UK facility in Billingham, Teesside. The investment more than doubles the site’s existing development and manufacturing footprint and will create a large, multi-modal biopharmaceutical manufacturing site in the United Kingdom. The new facilities are expected to be operational by late 2023 and up to 350 highly-skilled jobs are expected to be created.

The new campus will include two new state-of-the-art facilities: a viral gene therapy good manufacturing practice (GMP) facility and a GMP mammalian cell culture facility. The expansion is part of a ¥90 billion (US$791 million) global capital investment package that FUJIFILM Corporation initially outlined in 

The new cell culture facility in the Billingham campus will triple that site’s existing cell culture capacity with the addition of 4 × 2000-L and 2 x 500-L single-use bioreactors. Both monoclonal antibodies and novel antibody treatments will be manufacturing at the site. FUJIFILM will also add its MaruX GMP continuous manufacturing platform to the new facility, which will offer differentiated connected and integrated production.

The company’s viral vector and gene therapy services in Billingham will be expanded to offer dedicated process development capabilities as well as the new commercial-scale viral gene therapy GMP facility. The company’s gene therapy production capacity will grow ten-fold with this expansion. The Billingham viral vector facility will complement FUJIFILM’s existing facilities in College Station, Texas and Watertown, Mass. Both vaccine manufacturing and messenger RNA production will also be expanded at the Billingham site.

The viral vector and gene therapy manufacturing expansion at Bilingham follows a previous announcement in which FUJIFILM stated it plans to expands its viral vector and gene therapy offerings in Darlington, UK, to include process development laboratories and manufacturing capabilities to support the production of investigational gene therapies in early-stage clinical trials. The process development laboratories have already begun operations, with GMP manufacturing services slated to start up in spring 2022.

In addition to this current expansion, the company plans to expand its existing 5000-L GMP microbial production facilities on the Billingham campus, which will increase microbial fermentation capacity by almost two-thirds. The microbial production expansion, which is expected to be operational by late 2023/early 2024, will include over 20,000 ft2 of modular downstream cleanroom space, including two primary recovery and refolding suites, two purification suites, and a column packing room. The cleanroom space will be designed to implement the company’s SymphonX technology. Quality control (QC) labs, office space, and materials storage will also be included with this microbial production expansion.

“We all know that there has never been a more important time to invest in biopharmaceuticals—and £400 million, the largest investment in British biopharmaceutical manufacturing for decades, signals FUJIFILM Diosynth Biotechnologies’ intent to be able to offer multi-modal options to respond to our customers’ needs with flexibility and agility to help solve public health demands, and deliver the medicines and vaccines of tomorrow,” said Martin Meeson, CEO of FUJIFILM Diosynth Biotechnologies, in a company press release. “With a strong growing demand for microbial, cell culture, and viral gene therapy services, we are adding the capacity and latest technologies within one campus to offer a range of modalities to build an offering that will deliver novel promising treatments to patients for years to come.”

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

FUJIFILM Diosynth Biotechnologies to Create Major Biopharma Manufacturing Site in United Kingdom

The European Medicines Agency (EMA) has accepted Sanofi’s marketing authorization application (MAA) for olipudase alfa, an investigational enzyme replacement therapy being evaluated for the treatment of acid sphingomyelinase deficiency (ASMD). The MAA will be reviewed under an accelerated assessment procedure, and a European regulatory decision is anticipated in the second half of 2022, Sanofi announced in a Dec. 6, 2021, press release.

ASMD is historically referred to as Niemann-Pick disease (NPD) type A and type B. ASMD is a rare, progressive, and potentially life-threatening disease for which no treatments are currently approved, Sanofi stated in the press release. ASMD is estimated to affect approximately 2000 patients in the United States, Europe, and Japan. If approved, olipudase alfa will become the first and only therapy for treating this disease, according to Sanofi.

The MAA is based on positive results from two separate clinical trials that evaluated olipudase alfa in adult and pediatric patients with non-central nervous system manifestations of ASMD type A/B and ASMD type B. Olipudase alfa has received priority medicines designation from the EMA, breakthrough therapy designation from FDA, and Sakigake designation from Japanese regulatory authorities. Sanofi filed a Japanese new drug application for olipudase alfa in September 2021.

“Today’s milestone has been decades in the making, and our gratitude goes to the ASMD community who has stood by us with endless patience while olipudase alfa advanced through clinical development,” said Alaa Hamed, global head of Medical Affairs, Rare Diseases, Sanofi, in the press release. “Olipudase alfa represents the kind of potentially life-changing innovation that is possible when industry, medical professionals and the patient community work together toward a common goal.”

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

EMA Accepts MAA for Sanofi’s Rare Disease Therapy

American Regent, a Daiichi Sankyo Group company specializing in injectables manufacturing, announced on Dec. 16, 2021, that FDA approved Injectafer for pediatric patients with iron deficiency anemia (IDA) aged one or older. This approval provides an alternative means of treatment for patients who cannot take oral iron.

Injectafer is an iron replacement product originally approved by FDA for adults in 2013. Treatment consists of a two-dose intravenous injection of 750 mg separated by at least seven days. In patients weighing less than 50 kg (110 lb), this dosage is adjusted to 15 mg/kg of body weight.

"We are pleased to build on the effective and proven treatment of Injectafer for adult IDA patients with the approval of this new pediatric use," said Linda Mundy, chief medical officer at American Regent, in a company press release. "More than 1.7 million adult patients have been treated with Injectafer in the U.S. Pediatric healthcare providers now have an option for pediatric patients as young as one year of age with IDA who are intolerant to oral iron or who have had an unsatisfactory response to oral iron.”

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

FDA Approves American Regent’s Injectafer for Pediatric Patients

Pfizer announced on Dec. 13, 2021 that it had entered into a definitive agreement to acquire Arena Pharmaceuticals, a clinical stage company specializing in therapies treating immuno-inflammatory diseases, for $6.7 billion dollars. The acquisition gives Pfizer access to Arena’s diverse drug portfolio, most notably etrasimod, a drug candidate for the treatment of immune-mediated and inflammatory disease.

Etrasimod is an oral, selective sphingosine 1-phosphate (SIP) receptor modulator that is currently in development for a range of immuno-inflammatory diseases, including gastrointestinal and dermatological diseases. According to a company press release, a recent Phase II study on the effects of etrasimod on ulcerative colitis demonstrated that most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46 with etrasimod.

Arena’s portfolio also includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is in Phase II for the treatment of microvascular obstruction and Raynaud's phenomenon secondary to systemic sclerosis. APD418 is currently in Phase II for acute heart failure.

“The proposed acquisition of Arena complements our capabilities and expertise in inflammation and immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options,” said Mike Gladstone, global president and general manager, Pfizer Inflammation and Immunology, in a company release. “Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases.”

“We’re delighted to announce Pfizer’s proposed acquisition of Arena, recognizing Arena’s potentially best in class S1P molecule and our contribution to addressing unmet needs in immune-mediated inflammatory diseases,” said Amit D. Munshi, president and CEO, Arena, in the press release. “Pfizer’s capabilities will accelerate our mission to deliver our important medicines to patients. We believe this transaction represents the best next step for both patients and shareholders.”

Pfizer’s $6.7 billion acquisition of Arena will give them access to a portfolio of immuno-inflammatory therapies.