Pharmaceutical Technology Editors

AGC Biologics announced in May 2022 that it is adding viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colo. The new capabilities will start coming online in the third quarter of 2022 and will complement the site’s adherent viral vector and cell therapy offerings.

This expansion will more than double the Longmont site’s viral vector capacity and will help the company meet market demand. The expansion is part of AGC Biologics’ more than $30 million investment in the new Longmont campus. The new viral vector suspension capabilities include a full complement of bioreactor sizes for product development (AMBR, 10 L and 50 L), and a complete range of commercial manufacturing capacities (50 L, 200 L, 500 L, and 2000 L). The expansion will enable the site to provide support for the entire lifecycle of a product, according to a company press release.

AGC Biologics acquired the Longmont campus in August 2021. The company previously acquired a cell and gene therapy site in Milan, Italy, from MolMed in 2020.

“This investment helps AGC Biologics address the needs of gene therapy developers at our new central location in North America,” said Patricio Massera, CEO of AGC Biologics, in the press release. “When you combine these new capabilities and the technical expertise at our Longmont campus, with our Milan facility’s lentiviral vector platform and its extensive gene therapy CDMO [contract development and manufacturing organization] experience, we can now support virtually any viral vector program being developed anywhere in the world.”

“The suspension expansion helps us offer the most impactful, efficient and scalable technologies for bringing viral vector-based gene therapy products to market,” said Tony Fraij, general manager, AGC Biologics Longmont, in the press release. “This latest investment helps us round out the services we offer at this campus. Now, with a full suite of capabilities and the extensive expertise of our scientists, we can support virtually any type of viral vector or cell therapy development and manufacturing project.”

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AGC Biologics is investing in viral vector suspension technology at its new Longmont, Colo., facility.

AGC Biologics Adds Viral Vector Suspension Technology at New US Campus

Lubrizol Life Sciences has launched Apisolex, a novel solubility-enhancing excipient for use in parenteral drug products. The technology has the ability to overcome hurdles in solubility that do not have existing solutions.

According to the press release, 60–90% of potential new APIs that are currently in development and 40% of those in reformulation are poorly water soluble. Solubility impacts bioavailability and efficacy, which is especially relevant in the oncology field, as direct injection of drugs into the bloodstream ensures higher bioavailability and lower patient variability compared to oral delivery.

Apisolex technology is able to improve solubility and support high drug loading. It is meant to streamline manufacturing and minimize API loss and is a non-toxic, non-immunogenic alternative to PEG or surfactants.

“Apisolex is the first solubility-enhancing excipient for parenteral use introduced in more than 20 years,” said Rob Lee, president of the CDMO division of LLS Health, in the press release. “With its toxicity profile and simple processing techniques, Apisolex polymer can both improve existing drugs and enable some important new molecules.”

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

Lubrizol Launches Apisolex Technology 

AbbVie and Cugene, a clinical-stage biotechnology company specializing in autoimmune treatments, announced on May 16, 2022 an exclusive worldwide license option agreement for Cugene’s lead therapeutic candidate, CUG252, on May 16, 2022. CUG252 is a potential best-in-class regulatory T-cells-select-interleukin-2 (Treg-select IL-2) mutein that AbbVie plans to use in the development of treatments for autoimmune and inflammatory diseases.

Under agreement, Cugene will receive an upfront payment of $48.5 million from AbbVie. Conditional payment structures for achieving various development, regulatory commercialization, and sales-based milestones are also included.

According to a company press release, CUG252 is an engineered IL-2 mutein designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 receptor-expressing cells. In addition to CUG252, AbbVie also purchased access to other novel IL-2 muteins from Cugene. CUG252 is currently in a Phase I study in healthy volunteers.

"AbbVie is committed to developing novel therapies in immunology where unmet needs remain for patients living with complex autoimmune and inflammatory conditions," said Tom Hudson, senior vice-president, R&D, chief scientific officer, AbbVie, in the press release. "Our partnership with Cugene is the latest in our efforts to develop and advance potential next-generation therapies like CUG252."

"AbbVie is an ideal partner for CUG252, with [its] commitment to R&D, deep therapeutic area expertise, and the global resources needed to maximize CUG252's therapeutic potential for patients suffering from autoimmune diseases,” said Luke Li, CEO, Cugene, in the press release. “Today's agreement highlights Cugene's unique precision engineering platform that has yielded multiple product candidates, including CUG252. We look forward to collaborating with AbbVie to transform clinical outcomes in autoimmune disease."

AbbVie and Cugene have reached an exclusive license option agreement for CUG252, Cugene’s lead therapeutic candidate.

AbbVie and Cugene Form Autoimmune Disease Collaboration

Fluid Air, a division of Spraying Systems, announced that Sferalp, the R&D arm of Micro-Sphere, has selected their PolarDry technology for use in its research laboratory in Monteggio, Switzerland. Sferalp will use the PolarDry technology for powder processing with its commercial food, pharmaceutical, and nutraceutical customers.

“Our Swissmedic-certified laboratory is authorized to perform chemical-physical quality control tests on medicinal products and active substances in accordance with [good manufacturing practices] for medicinal products, and we know that we can count on Fluid Air technology to help achieve superior results for our customers,” said Michele Müller, general manager of Sferalp, in a May 10, 2022 company press release. “Fluid Air is the only provider in the marketplace whose technology can support our lab’s needs and help us meet the highest industry standards for quality and product performance.”

“Fluid Air is pleased to have its PolarDry technology used by an industry influencer [such as] Sferalp [and] is thrilled to have been selected as a key technology contributor to Sferalp[’s] important work,” said Michel Thenin, president, Fluid Air, in the press release.

Sferalp will use Fluid Air’s PolarDry technology for powder processing.

Sferalp to Use Fluid Air Technology for Laboratory Research

AstraZeneca has revealed in a May 23, 2022 press release, that its recombinant COVID-19 vaccine originally invented by the University of Oxford, Vaxzevria (ChAdOx1-S), has been given the nod by the European Medicines Agency (EMA) as a third dose booster vaccine for use in the European Union (EU).

Through this latest market authorization, healthcare professionals will be able to use the vaccine as a third dose booster in patients who have already been administered a primary vaccine schedule of either Vaxzevria or other EU-approved messenger RNA (mRNA) COVID-19 vaccines. The authorization has been based on EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation, for which there was a review of data demonstrating an increased immune response with a third dose booster Vaxzevria jab.

“[This] marketing authorization for AstraZeneca’s COVID-19 vaccine as a third dose booster is an important step towards our goal of providing continued protection against COVID-19 for all populations,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca, in the press release. “Ensuring a longer duration of immune protection is essential to the long-term management of COVID-19 globally, and boosters can address the waning of protection over time that has been seen with all primary vaccine schedules to date.”

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults

The European Medicines Agency (EMA) has provided its recommendation for Xenpozyme (olipudase alfa) to receive marketing authorization in the European Union (EU) for the treatment of non-central nervous system (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD), which is a rare and progressive genetic disease.

According to a May 20, 2022 press release, the therapy is indicated for use in children and adults of all ages who suffer from type A/B or type B ASMD—a genetic disorder that is historically referred to as Niemann-Pick disease types A (NPD A) and B (NPD B). Currently, there are no approved medicines that modify or slow the progression of the disease within the EU, meaning that patients are only able to receive palliative and supportive care to manage the symptoms.

Xenpozyme is an enzyme replacement therapy, available as a powder solution for intravenous administration every two weeks, that works by replacing the deficient or defective enzyme in patients. The replacement enzyme, which is produced by recombinant DNA technology, then lowers the fat accumulation in cells and relieves disease symptoms.

The recommendation for marketing authorization, made by EMA’s Committee for Medicinal Products for Human Use (CHMP), was based on the results from three clinical trials in patients with ASMD, which demonstrated positive outcomes of the therapy with only mild to moderate adverse events experienced. The therapy has been supported through EMA’s Priority Medicines (PRIME) scheme and CHMP reviewed the marketing authorization application under an accelerated assessment procedure.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union. 