Pharmaceutical Technology Editors

Tjoapack, a global pharmaceutical contract packaging organization, announced on April 13, 2022 that the expansion of its Etten-Leur facility in the Netherlands has been completed. The expansion follows an over €10 million investment into the facility. This is the company’s first investment since its acquisition of Pharma Packaging Solutions, a US healthcare packaging firm.

Tjoapack, which specializes in primary and secondary packaging of oral solids and injectables, has doubled its packaging capacity through the investment. The expansion includes the addition of 10 new production rooms and a total size increase of the facility from 8400m2 to 11,500m2. The expansion also includes three new production lines, a fully automated packaging line for vials, and two new high-speed production lines for oral solids. The facility now has a total of 18 packaging lines for blisters, vials, and bottles, with the capacity of packaging 12 million vials per year and 500 blisters per minute.

The company has also invested in increasing its warehousing and cold chain capabilities, as well as further increasing packaging capacity by the end of the year through purchasing more blister machines and a new packaging line for pre-filled syringes.

“Packaging is of course fundamental to the safe, effective delivery of virtually every pharmaceutical product,” said Boy Tjoa, managing director of Tjoapack, in a press release. “I am proud that through our expansion we can help bring even more products to market safely. We remain committed to our European headquarters and this latest investment is an important step to meeting the growing needs of our customers and assure healthcare products are usable, available, traceable, and affordable.”

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Tjoapack has doubled its packaging capacity with the completion of its Netherlands facility expansion.

Tjoapack Announces Completion of Netherlands Packaging Facility

VectorBuilder, a global gene delivery solutions company, announced on April 11, 2022 the construction of a new $500 million R&D and manufacturing center in Guangzhou, China. The ‘Gene Delivery Research and Manufacturing Campus’ will aid in the growth of the company, expanding its R&D capabilities and production capacity for various gene delivery vectors.

The campus will include a state-of-the-art contract development and manufacturing organization facility designed for current good manufacturing practice manufacturing of plasmids, messenger RNA (mRNA), AAV, lentivirus, cell lines, and other types of viral and non-viral vectors. The campus will also house a research institution dedicated to developing new gene delivery techniques, vector-based vaccines, virus-based cancer therapeutics, and training for scientists and engineers joining the gene delivery field.

Construction of the campus will be split into two phases over the next four years with an expected cost of $500 million and 100,000m2 of floor space. The project is part of a global expansion of the company, which is also planning new manufacturing sites in the United States, Europe, and Japan.

“Modern biology is largely built on gene delivery technologies, but until recently, such technologies are mostly limited to research use,” said Dr. Bruce Lahn, chief scientist at VectorBuilder, in a press release. “With the recent advancement of genetic medicine, gene vectors are now rapidly moving into clinical use, including CAR-T, gene therapy, mRNA vaccines, and oncolytic viruses. Some experts predict that in 10 to 20 years, vector-based drugs will become the third pillar of medicine, after small-molecule drugs and protein-based biologics. We are therefore expanding our R&D capabilities, as well as our manufacturing capacity, to continue leading the way in the development of innovative gene delivery technologies that will make research more efficient, and genetic medicine more effective and affordable.”

VectorBuilder will expand with the construction of new $500 million Gene Delivery Research and Manufacturing Campus in Guangzhou, China.

VectorBuilder to Expand with $500 Million Gene Delivery Research and Manufacturing Campus

SphingoTec, a German diagnostics company, announced on April 11, 2022 the implementation of two critical care biomarkers to guide the application of a potential new drug candidate for the treatment of COVID-19 patients. The trial will be led by University Hospital Hamburg-Eppendorf (UKE).

The trial will evaluate one of the first personalized approaches to treat moderate to severe COVID-19 with the drug candidate Adrecizumab (HAM8101; INN: enibarcimab) (1). The trial will use bioactive adrenomedullin (bio-ADM) as a biomarker to help with the early identification of endothelial dysfunction, a condition that has been shown to play a central role in the pathophysiology of COVID-19. Adrecizumab can then target high levels of bio-ADM in patients who have gone into septic shock. The use of this drug candidate has already shown favorable outcomes in a case series of eight severe COVID-19 patients.

The second biomarker in the trial will be dipeptidyl peptidase 3 (DPP3); but in this case, the second biomarker will be used to identify and exclude patients who exhibit high levels of DPP3. This is because DPP3 indicates that there is another underlying disease mechanism existing within the patient that can lead to cardiac depression. In that case, that patient would require a different therapeutic option than the Adrecizumab used in the trial. Both bio-ADM and DPP3 levels will be measured using SphingoTec’s rapid point of care platform Nexus IB10.

“Not all COVID-19 patients have the same disease course, and the pathology is very different,” said PD Dr. med. Mahir Karakas, part of the Department of Intensive Care Medicine at UKE. “Therefore, we have to adapt the treatment to each individual patient. We will now use in a double blind randomized multicenter trial the biomarker bio-ADM and DPP3 which proved to be useful for patient enrichment in a Phase II trial for treatment of septic shock.”

“The innovative biomarkers generate better insights into the pathophysiology of critically ill patients,” added Dr. Andreas Bergmann, founder of SphingoTec and co-founder of Andrenomed. “This is translated into clear decisions that allow a better treatment guidance and ultimately reduce mortality. This study represents a leap from “one drug fits all” to a personalized approach in treating COVID-19.”

1. Adrenomed, “Research & Development,” 

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.

University Hospital Hamburg-Eppendorf Leads Trial to Explore Personalized Medicine in COVID-19

Opus Genetics, a gene therapy company focused on inherited retinal diseases, announced on April 11, 2022 that it is entering a manufacturing services agreement with Resilience, a technology-focused biomanufacturing company, to support the development and manufacturing of Opus’ pipeline.

Resilience will provide process and analytical development, quality control testing, and good manufacturing practice manufacturing services for Opus’ adeno-associated viral (AAV) vector-based gene therapies for inherited retinal diseases for use in both preclinical studies and future clinical trials in the United States. This work will take place at Resilience’s facilities in Waltham, Mass., and Research Triangle Park, NC.

“Resilience embraces our innovative model to create a clinical manufacturing infrastructure that’s scaled to address rare inherited retinal diseases, and we are pleased to enter into this strategic collaboration,” said Ben Yerxa, PhD, CEO of the Foundation Fighting Blindness and the Retinal Degeneration Fund, and acting CEO of Opus, in a press release. “Leveraging Resilience’s expertise puts Opus in the best position to efficiently advance our AAV-based gene therapies into the clinic and toward the patients who need them.”

“Helping Opus advance their gene therapies for inherited retinal diseases to the clinic will hopefully lead to new treatments for underserved patients,” said Rahul Singhvi, ScD, CEO of Resilience, in the release. “We’re excited to partner with Opus on process development and manufacturing at this pivotal time for the company.”

Opus enters a strategic collaboration with Resilience for AAV-based gene therapy development and manufacturing for inherited retinal diseases.

Opus Enters Collaboration with Resilience for AAV-Based Gene Therapy Development and Manufacturing

Orchard Therapeutics, a global gene therapy company, announced on April 11, 2022 that it has reached a reimbursement agreement with the Italian Medicines Agency to enable access to Libmeldy (atidarsagene autotemcel) for all children with metachromatic leukodystrophy (MLD) who fall within the scope of the European marketing authorization.

MLD is a rare and life-threatening inherited disease of the body’s metabolic system that occurs in approximately one in every 100,000 live births. It is caused by a mutation in the 

gene that results in the accumulation of sulfatides in the brain, liver, gallbladder, kidneys, and/or spleen. Patients with MLD gradually lose the ability to move, talk, swallow, ear, and see.

“Following the February announcement of our landmark reimbursement agreement with NHS England, we are pleased that the Italian Medicines Agency has recognized the significant potential clinical benefit Libmeldy offers, granting it innovative status and agreeing to reimburse the therapy for all eligible MLD patients in the country,” said Braden Parker, chief commercial officer of Orchard Therapeutics, in a press release. “The momentum on our reimbursement negotiations is encouraging, as is our early progress in identifying patients in both Europe and the Middle East who may benefit from this therapy.”

Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.

Orchard Therapeutics Announces Reimbursement Agreement for Libmeldy

The European Commission (EC) has expanded the marketing authorization for Dupixent in the European Union (EU) as an add-on maintenance treatment of severe asthma with type 2 inflammation in children aged 6 to 11.

Severe asthma with type 2 inflammation is characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide. Dupixent is meant to be used when symptoms are inadequately controlled with medium to high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Asthma is one of the most common chronic diseases in children, with up to 85% having type 2 inflammation. Serious symptoms such as coughing, wheezing, and difficulty breathing can be experienced, and these symptoms can interfere with everyday activities and quality of life.

“Today’s approval in Europe recognizes the benefits of Dupixent in helping children living with the profound effects of severe asthma, including unpredictable asthma attacks, routine disruption to daily activities, and the use of systemic steroids that can impede children’s growth,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, in a press release. “Dupixent is the only treatment available that specifically blocks two key drivers of type 2 inflammation, IL-4 and IL-13, which our trials show plays a major role in childhood asthma, as well as in related conditions such as chronic rhinosinusitis with nasal polyposis and the often co-morbid condition, atopic dermatitis. In clinical trials, Dupixent significantly reduced asthma attacks, helped children breathe better and improved their health-related quality of life. We also remain committed to investigating Dupixent in other conditions where type 2 inflammation may significantly impact patients’ lives, including eosinophilic esophagitis, prurigo nodularis, and chronic spontaneous urticaria.”

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.