Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities.

Cell Therapy Manufacturing Amid Pandemic 

UK approves emergency use for Pfizer/BioNTech vaccine; industry ups manufacturing, awaits FDA EUA decisions.

Bio/Pharma Science Drives Pandemic Solutions

Honeywell announced on Dec. 3, 2020 that it successfully completed a remote control system migration for Richter Gedeon, a pharmaceutical and biotechnology company headquartered in Budapest, Hungary. The project was the first of its kind to enable plant operators to deploy advanced remote solutions to eliminate control technology obsolescence, enhance operations and improve business results, Honeywell stated in a company press release.

The migration project, which was deployed at Richter’s production facility in Dorog, northwest of Budapest, involved updating a Honeywell Experion PKS R431.5 control system to the latest R511.3 release. During the COVID-19 pandemic, the Honeywell service team executed the migration tasks using limited resources allowed on site and completed the work during strict schedule constraints associated with a plant shutdown.

Because of the pandemic, industrial companies are seeking ways to minimize their on-site presence while keeping equipment up-to-date and with minimum downtime. A failure to address outdated plant automation systems could lead to crucial assets being rendered inoperable. Organizations with a solid roadmap for ongoing technology upgrades can mitigate risks and drive plant operations seamlessly without unnecessary disruptions, Honeywell stated in its press release.

With the Remote Migration Services, Honeywell experts can perform control and safety system upgrades on a 24/7 schedule. This type of migration is performed in-house on Honeywell’s Virtual Data Center, which can be accessed remotely by technical support specialists along with local Honeywell staff and Richter’s on-site personnel. This access enables the fastest migration possible. The service includes migration readiness, software migration, offsite or remote acceptance testing, and production system upgrading. Honeywell specialists perform the software migration and then invite the end user to test the new Experion software release prior to introducing it into their production system.

Honeywell’s remote migration solution can improve project execution cycle time by as much as 50% and increase migration productivity by at least 60%, the company reported in its press release. Honeywell also offers enhanced industrial cybersecurity capabilities and control technology improvements to achieve optimum results.

“As a manufacturer of innovation-driven specialty pharmaceutical products, we believe there are significant benefits in proactively addressing the risks and issues of control technology obsolescence,” said Csaba Ódor, deputy head of the investment department for Richter Gedeon, in the press release. “Honeywell’s Remote Migration Services will help us reduce total cost of ownership, increase production rates, extend the life and performance of their systems, and improve response to changing business demands.”

“Honeywell’s strategy for remote control system migration is well-suited to the current business situation. By executing migration projects remotely, plant operators can reduce potential risk, minimize operational downtime, and make migration an advantageous experience rather than a burdensome requirement,” said Pramesh Maheshwari, vice-president and general manager, Lifecycle Services and Solutions, Honeywell Process Solutions, in the press release. “Beyond traditional on-process migration, the latest technology advancements allow system modernization to be performed on the cloud—just like a simple update. Industrial facilities can leverage value-added support on a remote basis with limited risks to their personnel or other assets.”

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Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

Honeywell Completes Remote Control System Migration for Hungarian Pharma Manufacturer

On Dec. 1, 2020, BioSkryb, a developer of genomic amplification technologies, reported the release of foundational data demonstrating that primary template-directed amplification (PTA) has a superior ability to accurately and uniformly amplify the genomes of single cells. The data was released on bioRxiv, the preprint server, prior to publication.

Whole genome amplification (WGA) is required for low-input DNA and single-cell analysis, and single-cell approaches are critical for tackling difficult biological questions involving genomic heterogeneity. Current WGA technologies and methods for single-cell or low-input DNA analysis, however, only cover a fraction of the genome, have a limited capacity to detect genetic variation in each cell, and suffer from significant biases, experimental artifacts, and poor reproducibility. The new data show that PTA can overcome these limitations as well as provide high-quality, scalable analysis of single-cell genomic heterogeneity. Having access to this analysis can enable new insights into human disease at the cellular level and empower high-resolution diagnostics for cancer, gene-editing, and other applications, BioSkryb stated in a company press release.

Furthermore, the PTA technology accurately calls genomic variants within tissues, one cell at a time, and reproducibly captures more than 95% of the genomes of those cells in a more controlled and accurate manner than existing approaches. According to the data released, PTA can be reliably used to call copy number variation in primary cancer cells and genome-wide variant detection in gene-edited cells. The technology can enable the feasibility of performing single-cell evaluations of biopsies from cancer and gene-edited tissues.

The PTA technology has been made a part of BioSkryb’s ResolveDNA kits, which contain all the enzymes and reagents needed for whole genome amplification from single cells or ultra-low DNA inputs. The kits employ a unique set of nucleotides to prevent recopying of the amplification products, which results in less errors and higher, more uniform coverage of the genome. The PTA technology also enables the attachment of cell barcodes to the resultant products for pooling and downstream analysis.

“We developed PTA to accurately and efficiently decipher genetic diversity at the cellular level so that we can better detect, understand, and treat disease,” said Charles Gawad, MD, PhD, inventor of the PTA technology, cofounder of BioSkryb, and associate professor at Stanford University, in the press release. “These data show that PTA amplifies the genomes of single cells with high coverage breadth and uniformity in a reproducible manner to significantly improve variant calling of all types. The ability of PTA to enable highly accurate genetic information at single-cell resolution could uncover new drug targets for cancer and neurological diseases as well as identify CRISPR off-target activity to monitor the safety and fidelity of gene editing.”

“Chuck and I cofounded BioSkryb to ensure researchers had access to the most advanced DNA analysis technologies, so it’s especially exciting to see the superior performance of PTA over current methods and to be able to make it commercially available through our ResolveDNA kits,” said Jay West, PhD, CEO, and cofounder of BioSkryb, in the press release. “Existing whole genome amplification methods uncover a fraction of the genomic information, but now with ResolveDNA, researchers can explore new places in the genome and be confident in the quality of the sequencing data at those sites.”

A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.

BioSkryb Discusses First Data Demonstrating Improved Accuracy in Single Cell Analyses

On Dec. 3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that they have entered into an agreement to include 4Tune Engineering’s iRISK platform in Cytiva’s cell therapy product offering.

Cytiva customers in the early stages of cell therapy product development will gain access to these tools, which can identify risks and evaluate and implement structured risk management plans. Cytiva research has shown that 75% of global respondents are actively developing or have a risk management program in place. With early stage development programs approaching commercial launch, some organizations are currently relying on manual processes or reactive mitigation strategies.

The iRISK platform is a fully integrated automated solution that identifies, quantifies, and prioritizes risks. The platform can also formulate risk mitigation strategies for new or existing processes throughout the manufacturing lifecycle. The platform can be customized to meet specific customer needs.

“The manufacture of cell therapies is inherently more risky than traditional biotherapeutics. As we look to improve the manufacturing process, working with 4Tune Engineering to provide our customers with an automated and structured risk management platform is a clear choice. Our customers will have peace of mind knowing they have a strong risk mitigation process in place,” said Catarina Flyborg, vice-president, Cell and Gene Therapy, Cytiva, in a company press release.

“Our collaboration with Cytiva will provide their customers with an automated, systematic, and user-friendly approach to risk management that will improve lifecycle management of cell and gene therapies and business performance of companies involved in that space,” added Marcos Domingues, CEO, 4Tune Engineering, in the press release.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management

KBI Biopharma, a JSR Life Sciences company, announced on Dec. 1, 2020 that it has opened a new $150 million commercial manufacturing facility in Research Triangle Park, NC.

Set to be operational by the first quarter of 2022, the 140,000-ft

 facility will feature up to six 2000-L, single-use bioreactor systems along with additional harvest and purification equipment to produce up to 100 commercial batches annually, a company press release said. The new site will also be equipped to provide accommodations for mammalian-based biologics manufacturing processes for KBI’s future and existing collaborators.

“Expansion of our US-based cell culture operations is a key investment to support our client’s commercialization strategies,” said KBI president and CEO Dirk Lange in the press release. “This state-of-the-art facility will leverage the latest innovation in automation and digitalization to best meet the needs for our clients.”

Set to be operational by the first quarter of 2022, the 140,000-ft2 facility will feature up to six 2000-L, single-use bioreactor systems along with additional harvest and purification equipment to produce up to 100 commercial batches annually. 

KBI Biopharma to Open $150 Million Commercial Manufacturing Facility in North Carolina

Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced on Dec. 2, 2020 that it has acquired US-based biotechnology company Hemera Biosciences’ investigational gene therapy, HMR59, for the preservation of vision in patients with geographic atrophy, a form of age-related macular degeneration (AMD).

According to a Janssen press release, the gene therapy works to increase the ability of retina cells to make a soluble form of CD59, a protein that shields the retina from damage, to prevent additional damage to the retina and to preserve vision.

“Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James F. List, MD, PhD, global therapeutic area head, Cardiovascular and Metabolism, Janssen Research & Development, in the press release. “Our aim with this novel, single-administration gene therapy is to use our development expertise and deep heritage in vision care to help improve patient outcomes by intervening early, halting the progression to blindness, and preserving more years of sight.”

The gene therapy increases the ability of retina cells to make a soluble form of CD59, a protein that shields the retina from damage, to prevent additional damage and to preserve vision. 

Janssen Pharmaceuticals Announces Acquisition of Vision Care Gene Therapy

Johnson & Johnson announced on Dec. 1, 2020, that the company has initiated rolling submissions with Health Canada and the European Medicines Agency for Janssen’s investigational single-dose vaccine candidate for the prevention of COVID-19.

The reviews are based on positive non-clinical data showing that the vaccine candidate elicited a robust immune response, as demonstrated by neutralizing antibodies, in an ongoing Phase I/IIa clinical trial that is studying the safety profile and immunogenicity of a single-dose and two-dose vaccination. Immune responses were similar across the age groups studied, including older adults, the company reported in a press statement. The Janssen COVID-19 vaccine candidate is being evaluated in Phase III clinical trials.

The investigational COVID-19 vaccine candidate uses Janssen’s AdVac vaccine platform, which was also used to develop and manufacture the company’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates, the company reported.

Janssen reported in the statement that the company “is committed to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use.”

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

J&J Initiates COVID-19 Vaccine Approvals in Canada and Europe

Colorcon announced on Dec. 3, 2020 that it is entering into a research collaboration with i2O Therapeutics, a US-based biotechnology company, to aid in the development of i2O’s liquid technology for the oral delivery of challenging drugs.

Under the terms of the partnership, Colorcon will work to accelerate the company’s research and development efforts, a Colorcon press release said.

“We are excited to collaborate with Colorcon to help advance our ionic liquid technology given their rich history of innovation and expertise in pharmaceutical development,” said Samir Mitragotri, PhD, co-founder of i2O Therapeutics, in the press release.

“Colorcon Ventures’ strategic focus on technologies that transform conventional delivery pathways aligns well with i2O,” added Martti Hedman, Colorcon’s CEO, in the press release. “The ability to deliver injectable therapies orally has the potential to significantly improve patient adherence and outcomes.”

Under the terms of the partnership, Colorcon will work to accelerate i2O’s research and development efforts.

Colorcon and i2O Therapeutics Partner for Liquid Technology Development 

According to a Dec. 2, 2020 press release, the Cell and Gene Therapy Catapult (CGT Catapult) has launched the Advanced Therapies Skills Training Network (ATSTN), designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the United Kingdom.

The nationwide initiative, driven by industry and coordinated by the CGT Catapult, comprises dedicated online resources and national centers to upskill, and provides an opportunity for people to identify how they can enter the industry. ATSTN is funded by an award of £4.7 million (US $6.3 million) from the Department for Business, Energy & Industrial Strategy (BEIS) through UK Research and Innovation (UKRI).

“It is vital that we upskill our workforce to develop and manufacture vaccines and treatments at scale, ensuring the advanced therapy and vaccine manufacturing sectors are stronger and more resilient in the future,” said UK Business Secretary Alok Sharma, in the press release. “Backed with almost £5 million government investment, this first-of-its-kind skills network will equip people at all stages of their careers to pursue opportunities in advanced medicines and vaccine manufacturing. This will help to create highly skilled jobs across the country while putting the UK in the strongest position to respond to future pandemics.”

“One of the tasks of the government’s Vaccines Taskforce is to ensure the UK has the capabilities to respond to future health crises, and this includes scaling up our ability to manufacture safe and effective vaccines and treatments,” added Kate Bingham, chair of the Vaccines Taskforce, in the press release. “By upskilling and expanding the UK’s vaccine manufacturing industry, this new skills network will help to ensure the UK has the capacity to produce successful vaccines at scale, including for coronavirus, helping to protect the UK population for generations to come.”

“The ATSTN initiative reiterates our commitment to upskill new and existing members of the advanced therapy workforce, building on the success and impact of the ATAC apprenticeship program,” commented Matthew Durdy, CEO of CGT Catapult, in the press release. “Not only is it rewarding to work so closely with industry to deliver on this need, but it is also extremely motivating for all involved to think that this initiative is going to be the start of so many promising careers and additional job opportunities. We look forward to seeing the success stories from users of this ground-breaking platform.”

CGT Catapult has launched the Advanced Therapies Skills Training Network, designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the UK.

Nationwide Skills Development Program for Advanced Therapies Launches in UK

Clinical-stage company, eTheRNA Immunotherapies, has entered into a strategic cooperation and product license agreement with China Grand Pharmaceutical and Healthcare Holdings to form a new joint venture company, Nanjong AuroRNA Biotech.

As reported in a Dec. 2, 2020 press release, the newly formed company will be located in mainland China and will deploy eTheRNA’s proprietary mRNA technology for pharmaceutical R&D and production in the greater China region. The formation of AuroRNA Biotech follows the equity investment by China Grand Pharma in eTheRNA’s Series B financing round, which occurred earlier in 2020 and provides eTheRNA access to the greater China market for selected mRNA cancer and infectious disease vaccine programs, its proprietary mRNA formulation technologies, and good manufacturing practice manufacturing process technology.

Under the terms of the agreement, AuroRNA Biotech will gain an exclusive license for eTheRNA’s mRNA technology platforms in the greater China region (Mainland China, Hong Kong SAR, Macau SAR, and Taiwan). Technology support for the new company will be provided by eTheRNA as the new company establishes itself and an exclusive license to develop, manufacture, and commercialize eTheRNA’s HPV-positive head and neck cancer development product in the greater China region has been granted to AuroRNA Biotech.

“We are delighted to have secured our first corporate partnership with one of China’s top 10 pharmaceutical companies,” said Dr. Steven Powell, CEO of eTheRNA, in the press release. “This will undoubtedly bring another dimension to our business at a time when mRNA technology is demonstrating its high potential through products developed by companies including BioNTech, Curevac, and Moderna to thwart the COVID-19 pandemic. We look forward to forging additional international partnerships in the coming year.”

eTheRNA Immunotherapies has entered into a strategic cooperation and product license agreement with China Grand Pharmaceutical and Healthcare Holdings to form a new joint venture company, Nanjong AuroRNA Biotech.

Joint Venture Company Forms to Deploy eTheRNA’s Technology for R&D

On Dec. 1, 2020, PlantForm, a privately held Canadian biopharmaceutical company, announced that the Natural Sciences and Engineering Council of Canada (NSERC) awarded it and its research partner, University of Alberta (UAlberta) scientist Dr. Warren Wakarchuk, an Alliance Grant to conduct research that will enable the commercial-scale production of effective, low-cost, plant-made protein therapeutics, including an antidote to chemical nerve agents.

The Wakarchuk lab pioneered the use of enzymes to make or remodel glycans, which play a key role in regulating immune cell signaling and function, and PlantForm’s plant-based manufacturing system for large-molecule protein drugs (biologics) requires glycan remodeling. Glycan remodeling on proteins effectively mimics human glycan structures, which reduces the risk of rejection and improves the circulation lifetime of the protein, according to PlantForm in a company press release.

The two-year project, which will be supported by $184,000 from NSERC plus a $92,000 cash and in-kind investment by PlantForm, will focus on using 

 glycan remodeling to improve the efficacy and serum half-life of butyrylcholinesterase (BuChE), a countermeasure for chemical nerve agents, such as soman and sarin. The BuChE is produced using PlantForm’s proprietary plant-based vivoXPRESS platform. The researchers will use enzymes engineered by the Wakarchuk team to remodel glycans on target proteins for improved stability and drug efficacy, with a focus on commercial-scale production.

“This Alliance Grant expands and strengthens our research collaboration with Dr. Wakarchuk and his team to continue to advance our novel glycosylation technology for our pipeline of innovative protein-based drugs,” said Dr. Don Stewart, PlantForm’s president and CEO, in the press release.

“Plants are an excellent alternative to mammalian cell cultures for the low-cost production of protein-based drugs. But the production of the authentic human glycan structures is difficult to control in both mammalian- and plant-based expression systems,” said Wakarchuk, a professor in the Department of Biological Sciences at the Faculty of Science as well as scientific director of GlycoNet, a pan-Canadian Network of Centers of Excellence consisting of more than 140 researchers centered in UAlberta, in the press release.

The grant will support the advancement of glycoengineering technology for plant-derived proteins developed by a University of Alberta scientist partnered with PlantForm.

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Cell Therapy Manufacturing Amid Pandemic

Bio/Pharma Science Drives Pandemic Solutions