Pharmaceutical Technology Editors

ViroCell Biologics, the UK’s first clinical trial-focused viral vector manufacturer, announced its official launch on April 28, 2021.

ViroCell will aim to be the supplier for viral vectors and gene modified cells, to academic and corporate clients, for translational cell and gene therapies going into clinical trials, the company said in a press release. Currently, the company is in negotiations with teaching hospitals and universities to provide more cleanroom facilities for the production of viral vectors in the UK.

The contract development and manufacturing organization was first founded in 2020 by the Truell Conservation Foundation and serial biotech entrepreneur, John W. Hadden II, who will serve as CEO. Farzin Farzaneh, PhD, professor of Molecular Medicine at King’s College London, will serve as chief scientific officer

“We have been studying the viral vector supply-demand imbalance with great interest,” said Edmund Truell, chairman of the Truell Conservation Foundation, in the press release. “We believe that the shortage of highly specialized design and manufacturing capacity and the UK’s hitherto uncommercial attitude to new vector innovation represents a clear barrier to gene therapy innovation. Farzaneh’s leadership in developing and manufacturing viral vectors will build on the excellent genetics research at the Wellcome Sanger Institute, King’s College London, and other world-class centers of academic research, and our globally powerful pharmaceutical sector. We are delighted to capitalize and invest in ViroCell to accelerate the novel therapies that ViroCell’s clients are developing by enabling them to enter clinical trials faster and so help millions of patients.”

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ViroCell will supply viral vectors and gene modified cells, to academic and corporate clients, for translational cell and gene therapies going into clinical trials.

ViroCell Launched in the UK to Manufacture Viral Vectors

Pfizer announced on April 28, 2021 that it has acquired Amplyx Pharmaceuticals, a US-based pharmaceutical company focused on the development of therapies for diseases that affect people with compromised immune systems.

Through the acquisition, Pfizer will have access to Amplyx’s lead compound, Fosmanogepix (APX001), an investigational asset under development for the treatment of invasive fungal infections, Pfizer said in a company press release. The compound is currently involved in Phase II clinical trials to evaluate the safety and efficacy of intravenous and oral formulations for the treatment of patients with invasive fungal infections from molds, yeasts, and rare molds. Pfizer will also acquire Amplyx's early-stage pipeline that includes potential antiviral (MAU868) and antifungal (APX2039) therapies.

“The COVID-19 pandemic has been a stark reminder of the devastating impact of infectious diseases, highlighting the continuous need for new anti-infective therapies to treat both emerging and difficult to treat bacterial, viral, and fungal infections,” said Angela Lukin, global president, Pfizer Hospital, in the press release. “We are deeply committed to helping patients suffering from infectious diseases, continuously seeking opportunities to build our portfolio of anti-infective therapies. We’ve already invested in assets that, if approved, could help address drug-resistant bacterial infections and critical viral infections; with this acquisition, we look forward to progressing the development of a novel anti-fungal as well.”

Through the acquisition, Pfizer will have access to Amplyx’s lead compound, Fosmanogepix (APX001), an investigational asset under development for the treatment of invasive fungal infections.

Pfizer to Acquire Amplyx Pharmaceuticals

Moderna announced on April 29, 2021 that it is making new funding commitments and is increasing supply at its manufacturing facilities in order to increase the global supply of its COVID-19 vaccine to up to three billion doses in 2022.

The investments will include the doubling of formulation fill/finish and drug substance manufacturing at Rovi’s Spain-based facility, and a 50% increase of drug substance at Moderna’s facilities in the United States, Moderna said in a company press release. Lonza also announced on April 29, 2021 that it has agreed to expand its ongoing collaboration with Moderna to double drug substance manufacturing for the vaccine at Lonza’s Visp, Switzerland, site. This investment will include the addition of new manufacturing lines expected to be operational in early 2022.

After the investments are completed, Moderna expects an increase in safety stock of raw materials and finished product used to deliver committed volumes.

“As we follow the rapid spread of SARS-CoV-2 variants of concern, we believe that there will continue to be significant need for our mRNA COVID-19 vaccine and our variant booster candidates into 2022 and 2023. We are hearing from governments that there is no technology that provides the high efficacy of mRNA [messenger RNA] vaccines and the speed necessary to adapt to variants, while allowing reliable scalability of manufacturing. Today we have announced that our investments in Europe, including Spain, France, and Belgium, Switzerland, and the US will allow us to deliver up to three billion doses in 2022, depending on the mix of product between primary series of vaccination and variant boosters,” said Stéphane Bancel, CEO of Moderna, in the press release. “We thank our manufacturing partners for their work and their commitment. Together with our partners, Moderna is committed to continuously developing best-in-class variant boosters so we can end this pandemic as fast as possible.”

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites. 

Moderna Announces Additional Investments to Increase COVID-19 Vaccine Supply for 2022

ADMA Biologics, a commercial biopharmaceutical company, announced on April 28, 2021 that FDA has approved its expanded manufacturing process for the fractionation and purification of a 4400-L plasma pool for the manufacture of its intravenous immune globulin (IVIG), Bivigam.

The approval allows for the company to expand its manufacturing plant’s total processing capacity from 400,000 L to an anticipated peak throughput of up to 600,000 L, ADMA said in a company press release. Additionally, ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

“The FDA approval of the 4400-liter IVIG plasma pool production scale process is a transformative milestone for the ADMA organization and will allow the company to produce significantly more IVIG for the US market and for patients living with immune deficiencies,” said Adam Grossman, president and CEO of ADMA, in the press release. “The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022.”

ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

FDA Approves ADMA Biologics’ Expanded Manufacturing Process for Intravenous Immune Globulin

Catalent announced on April 27, 2021 that it has entered into a partnership with AavantiBio, a US-based gene therapy company, to support the development of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA), a genetic disease caused by low levels of the protein frataxin due to mutations in the FXN gene.

Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe, Catalent said in a company press release. Catalent will also provide process optimization while reducing material timelines at its process and clinical development center in Baltimore.

“We look forward to working with Catalent on the development of our differentiated pipeline of innovative gene transfer therapies, focused initially on our FA program,” said Bo Cumbo, president and CEO of AavantiBio, in the press release. “This partnership highlights the importance of prioritizing chemistry, manufacturing, and controls as a foundational element of the company. We believe this approach will position AavantiBio for long-term success as we begin to advance therapies to transform the lives of patients with FA and other rare diseases.”

“Catalent is committed to partnering early with innovative companies and facilitating the development and optimization of robust, scalable manufacturing solutions,” added Manja Boerman, PhD, president, Catalent Cell & Gene Therapy, in the press release. “Our development team at the University of Maryland BioPark is focused on providing process optimization services to meet our customers’ needs and partnering with them to bring innovative therapies to patients faster.”

Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe.

Catalent Enters into Gene Therapy Manufacturing Collaboration with AavantiBio

Avantor announced on April 26, 2021 that it is increasing its global capacity for high-quality single-use technologies used in the production of biologics and vaccines.

According to a company press release, Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe. The expansion will also support customer demand for monoclonal antibodies, cell and gene therapies for oncology and other diseases, and vaccines, including those for COVID-19.

"The industry's response to the COVID-19 pandemic has relied heavily on the integration of single-use products into biopharma production processes,” said Ger Brophy, executive vice-president of Biopharma Production at Avantor, in the press release. “Efficacy and safety are of the utmost importance to our customers, and they look to us to understand and support their requirements as they rapidly expand their own manufacturing capacity. These additions to our global single-use manufacturing ecosystem are critical steps in enabling our customers to get therapies to patients quickly.”

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.