Pharmaceutical Technology Editors

Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system diseases, announced on Feb. 22, 2022 the dosing of its first patient in its Phase IIb LibraTN clinical trial of the mGluR5 inhibitor NOE-101 in trigeminal neuralgia (TN). LibraTN is a multi-center, 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study to further evaluate the efficacy and safety of NOE-101 in adults with pain associated with TN.

TN is a chronic pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. TN is a form of neuropathic pain associated with nerve injury or nerve lesion. According to the press release, new cases of TN affect four to five of every 100,000 people in the United States each year.

NOE-101 is a highly selective, potent, and cell-penetrant negative allosteric modulator of mGlu5 receptors for the management of pain associated with TN.

"It's very exciting to have dosed our first patient in this Phase 2b trial in trigeminal neuralgia. We see great potential for NOE-101 in pain management due to its ability to block the nuclear membrane mGlu5 receptors which are overexpressed in chronic pain," said George Garibaldi, Chief Medical Officer of Noema Pharma, in the press release. "Treatment options are scarce in TN with only one treatment option that was approved over 50 years ago. We believe that patients suffering from TN deserve the benefit of the latest mechanistic discoveries. NOE-101 has great potential to provide these patients with the efficacy they need and a safety profile compatible with long-term use.”

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Noema Pharma announces first patient dosed in its Phase IIb clinical trial of mGluR5 inhibitor NOE-101 in trigeminal neuralgia.

Noema Pharma Announces First Patient Dosed in Study Evaluating Efficacy of NOE-101 for Trigeminal Neuralgia

Hoffmann Neopac, a privately held company headquartered in Thun, Switzerland that produces metal and plastic packaging for pharmaceutical, cosmetics, and consumer goods manufacturers, has become the first tube manufacturer to sign a partnership with Saperatec, the first industrial recycling plant for aluminum laminate composites, on Feb. 22, 2022. Neopac will begin supplying its production waste to Saperatec upon the plant’s opening in mid-2023.

According to the press release, Europe produces approximately 11.5 billion tons of plastic, aluminum, and laminate tubes annually; 38% of this waste is laminate tubes, with the majority comprising aluminum barrier laminates (ABL). Currently, these tubes cannot be industrially separated and recycled in existing recycling facilities. Instead, they are usually downcycled, incinerated, or, depending on the country, dumped into landfills.

The technology spearheaded by Saperatec GmbH has demonstrated the ability to break down multilayer composite materials into their individual materials, enabling a high level of material recycling. Using a special washing technique, Saperatec separates plastic and aluminum layers without dissolving them. A spring 2021 laboratory study with various ABL tubes from Neopac showed that its Polyfoil tubes, for example, can be completely separated in this fashion.

After this separation process, the materials are sorted, which produces fractions of polyethylene and aluminum, which can be recycled to high quality in commercially available plants. This process will also make it possible to recycle composite materials made of aluminum and plastic with high recycling rates.

"In addition to the already existing environmentally friendly and recyclable tubes from our EcoDesign portfolio, we are committed to a recycling solution for our conventional Polyfoil ABL tubes. With this new initiative, we will offer our customers the best possible balance between product safety and sustainability," stated Peter Bossert, Head of Materials Development at Hoffmann Neopac AG, in the press release. "As early as this year, we will make a portion of our production waste available to Saperatec to demonstrate its recyclability on an industrial scale, per the promising laboratory tests that have been performed. With the pending recycling of ABL tubes, we are closing a recycling gap in our portfolio."

Hoffman Neopac has signed a partnership with Saperatec to begin recycling aluminum laminate composites upon its opening in mid-2023. 

Hoffmann Neopac Partners with Saperatec for Recycling of Aluminum Laminate

The European Medicines Regulatory Network has adopted a Common Standard for the electric product information (ePI) on medicines in the EU on Feb. 22, 2022. The Common Standard was one of the key deliverables of an ePI project run by the European Medicines Agency (EMA), national competent authorities (NCAs), and the European Commission (EC) in 2021.

The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. Every single medicine authorized in the EU includes these documents that help explain how it should be used and prescribed.

The adoption of the Common Standard will allow for the spread of unbiased, up-to-date information on all medicines available to patients in the EU. The EU ePI Common Standard will provide the ability to harmonize electronic information on medicines within the EU and improve the delivery of information for patients, consumers, and healthcare professionals for better decision making. The ePI can be updated immediately as new information becomes available and can be personalized to be more easily accessible to users with diverse abilities.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

European Medicines Regulatory Network Adopts EU Common Standard for Electric Product Information

Quotient Sciences announced on Feb. 17, 2022 that it has integrated drug substance into its flagship Translational Pharmaceutics platform. This newly integrated service combines drug substance, drug product, and clinical testing activities all under one unified organization and project manager.

The approach of combining manufacturing and clinical dosing at a single organization allows innovators to adjust formulations and dosing in real time. Translational Pharmaceutics was developed in consultation with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and FDA and utilizes a rapid “make-test” cycle, where drug products are manufactured, released, and dosed in a clinical study in days rather than months.

“Our Translational Pharmaceutics platform is now in its 15th year and has accelerated development timelines for more than 500 drug programs,” commented Mark Egerton, CEO of Quotient Sciences, in a press release. “We remain the only outsourcing partner able to offer innovators the ability to manufacture, release and dose under one organization. This approach is proven to shave 12 months off timelines and, by adding drug substance synthesis, the timeline from candidate selection to clinic can be further accelerated by 2–4 months.”

Quotient Sciences announces that it has integrated drug substance into its flagship Translational Pharmaceutics platform.

Quotient Sciences Completes Integration of Drug Substance into Translational Pharmaceutics Platform

Recipharm announced on Feb. 18, 2022 that it has acquired Vibalogics and Arranta Bio, both contract development and manufacturing organizations (CDMOs), expanding its manufacturing capabilities in the virotherapy and advanced therapy spaces, respectively.

Vibalogics, a virotherapy CDMO and a portfolio company of Ampersand Capital Partners, has been making it presence known in the biopharma industry by providing specialized CDMO services for the manufacture of live viruses and viral vectors, including herpes viruses, pox viruses, adenoviruses, and other viral classes for cancer and other applications. The company has also has recently expanded in both Germany and the United States.

The acquisition of Vibalogics will give Recipharm capabilities in new biologics modalities and will allow Recipharm to build on the capabilities also acquired through the Arranta Bio buyout as well as another recent transaction, the acquisition of Genlbet, a Portuguese CDMO specializing in the manufacture of biological clinical trial material and novel modalities, such as viral vectors, RNA, and microbiome. Recipharm announced its acquisition of Genlbet on Feb. 1, 2022 (1). 

"We are delighted to welcome our new colleagues from Vibalogics to Recipharm and are committed to support and even accelerate growth in the years to come and to continue to partner with customers in virus manufacturing solutions. This acquisition strengthens Recipharm’s presence in ATMPs [advanced therapy medicinal products] and enables us to get closer to our US customers," said Marc Funk, CEO at Recipharm, in a company press release.

The Arranta Bio acquisition, which is expected to close by the end of March 2022, gives Recipharm a strong microbiome platform with fermentation and purification expertise for naturally-derived and engineered bacteria consortia, alongside analytics, proprietary media, and cryopreservative formulations. These services aim to maximize yields and enhance viability for live biotherapeutic products being tested in the clinic against a range of infectious, inflammatory, neurological, and oncological diseases. 

In addition, to help combat supply chain obstacles, Arranta Bio is also advancing the supply of end-to-end messenger RNA capabilities across drug substance and drug product under one roof.

“Arranta is a leading player in its field that we are proud of bringing under the Recipharm umbrella and continue to build in line with our vision of supporting biotechs by providing process development, manufacturing expertise, and bold solutions to take their programs from lab to patient,” said Funk in the press release.

1. Recipharm, "Recipharm Acquires GenIbet to Bolster Biologics Offering," Press Release, Feb. 1, 2022.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

Recipharm Acquires Two Biologics CDMOs: Vibalogics and Arranta Bio

BioNTech SE aims to improve vaccine supply in Africa by developing and delivering turnkey messenger RNA (mRNA) manufacturing facilities based on a container solution, the company said in a Feb. 16, 2022 press release. This modular-facility approach is designed to create scalable vaccine production that could become a decentralized manufacturing network.

BioNTech presented the container solution named “BioNTainer” at a meeting attended by key partners including the presidents of Ghana, Rwanda, and Senegal; the director-general of the World Health Organization; the director of the Africa Centers for Disease Control and Prevention; and the Federal Minister of Economic Cooperation and Development of Germany.

The group discussed the infrastructure, regulatory, and technological requirements needed to establish an end-to-end manufacturing network for mRNA-based vaccines in Africa.

“mRNA vaccines made in Africa, for Africa, with world-class technology. This initiative is a real trailblazer in our global fight against the pandemic,” said Ursula von der Leyen, president of the European Commission, in the press release. “By pooling forces, the European Union and the African Union can achieve so much more, for mutual benefit. Team Europe has committed one billion Euros. And the EU will support Africa’s ambition to build up vaccine manufacturing and regulatory capacities.”

Each BioNTainer cleanroom module is built of six ISO-sized containers (2.6m x 2.4m x 12m). A drug substance module and a formulation module are used to produce mRNA vaccine in bulk, and fill/finish of the bulk vaccine is done by local partners. Two modules offer an estimated initial capacity of, for example, up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year, according to the press release. Capacity can be scaled up by adding further modules and sites to the manufacturing network.

The first BioNTainer is expected to arrive in Africa in the second half of 2022, and production is planned to begin approximately 12 months after the delivery of the modules. BioNTech expects to ship BioNTainers to Rwanda, Senegal, and potentially South Africa. BioNTech will be responsible for the delivery and installation of the modules, and local organizations will provide infrastructure. BioNTech will initially staff and operate the facilities and then will transfer know-how to local partners to enable independent operation. BioNTech will partner with local quality control testing labs for tests for each finished vaccine batch. Vaccines manufactured in these facilities are expected to be dedicated to domestic use and export to other member states of the African Union at a not-for-profit price.

“The modular production facilities are a big step in our journey to enable the production of high-quality mRNA vaccine manufacturing worldwide, with each BioNTainer becoming a node in a decentralized and robust African end-to-end manufacturing network,” said Sierk Poetting, COO of BioNTech, in the press release. “The modular and scalable approach could allow us to set-up turnkey manufacturing sites for mRNA on all continents. Once rolled out, the approach could support clinical trials as well as regional pandemic preparedness measures.”

The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines, such as the Pfizer-BioNTech COVID-19 vaccine. It could also be used to manufacture BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved, or authorized by regulatory authorities.

The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.