Pharmaceutical Technology Editors

Charles River Laboratories announced on Feb. 13, 2023 the launch of its first Enzyme-Linked Immunosorbent Assay (ELISA) kit for the detection and quantitation of residual host cell proteins (HCP) in Chinese hamster ovary (CHO)-based biotherapeutics.

The new HCP-ELISA kit leverages avian immunoglobulin Y (IgY) antibodies as the primary detection technology. These antibodies are derived from specific-pathogen-free chicken (SPF) eggs developed exclusively by AVS Bio. The HCP-ELISA kit builds upon Charles River’s HCP-GAPex service, increasing the efficiency and efficacy of HCP assay development.

“With more than 30 years of impurity testing experience, host cell protein assays are one of our core competencies,” said Kerstin Dolph, corporate senior vice president, biologics solutions, Charles River, in a company press release. “Building on that expertise to bring our inaugural kit to market was the next logical step to strengthen our Biologics Testing offering.”

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The kit is meant for use for the detection and quantitation of residual host cell protein.

Charles River Launches Novel IgY-based ELISA Kit

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has begun their review, as of Feb. 10, 2023, of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which are conditions affecting blood vessels in the brain.

PRES and RCVS can lead to reduced blood supply, or ischemia, to the brain and may lead to major and life-threatening complications in some cases. Some of the most common symptoms associated with these conditions include headache, nausea, and seizures.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy. Most pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischemic events, such as stroke or heart attack.

The recent review follows new data from a small number of cases of PRES and RCVS in patients using pseudoephedrine-containing medicines, which were reported in pharmacovigilance databases and the medical literature.

The PRAC will continue to review available evidence and make decisions on whether the marketing authorizations for pseudoephedrine-containing medicines should be maintained, varied, suspended, or withdrawn across the EU.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy. 

New Data from EMA’s Review of Medicines with Pseudoephedrine

Novartis announced that FDA has accepted Sandoz’s biologics license application (BLA) for the proposed biosimilar denosumab. The application features all indications covered by the reference medicines Prolia (denosumab) and Xgeva (denosumab) for treating multiple conditions, such as osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” said Keren Haruvi, president of Sandoz Inc. and Head of North America, in a press release. “We are proud to be among the first to submit a BLA for a denosumab biosimilar as, if approved, it could increase patient access to an affordable, high-quality, potentially disease-modifying treatment across the US, while also delivering savings for healthcare systems.”

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. According to the company, the results confirmed that the proposed biosimilar denosumab matches the reference medicine in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity in women with postmenopausal osteoporosis and contributes to the demonstration of similarity, which is the basis for use in all indications.

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study. 

FDA Accepts Biologics License Application for Proposed Biosimilar Denosumab 

On Feb. 7 2023, Elektrofi, a biotechnology company focused on drug formulation and delivery innovations, announced a contract manufacturing agreement with Thermo Fisher Scientific to support the manufacturing of Elektrofi’s ultra-high concentration subcutaneous products.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting. The new collaboration will facilitate the establishment of a platform current good manufacturing practice (CGMP) line and is scheduled to be operational in early 2024. This is intended to support early clinical efforts across a variety of pipeline programs and enable rapid scale-up for late-stage and commercial development.

“We are eager to begin investigating our subcutaneous delivery technology in human clinical trials to explore how it can positively impact the healthcare space, both by easing the burden on patients and caregivers and by improving therapeutic outcomes,” said Chase Coffman, CEO and co-founder of Elektrofi, in a press release. “To successfully initiate clinical development, we need to establish certified CGMP manufacturing capabilities. We’re thrilled to partner with Thermo Fisher, a global leader in development and manufacturing, to meet this goal and continue advancing our efforts to change the way biologic-based drugs are delivered.”

Elektrofi’s proprietary microparticle technology enables small-volume injections for biologics, like monoclonal antibodies or other large-molecule drugs. The technology is intended to help overcome the need for patients to get treated at hospitals or infusion centers.

“Our expertise in drug development and manufacturing will help Elektrofi pioneer a significant advance in how medicine is introduced into patients,” said Leon Wyszkowski, president of Commercial Operations, Pharma Services for Thermo Fisher Scientific, in a press release. “We deeply appreciate their confidence in us and look forward to the clinical research progress we will make together."

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting. 

Elektrofi Establishes Contract Manufacturing Agreement with Thermo Fisher Scientific

Pharmapack Europe announced the winners of the 2023 Pharmapack Awards on Feb. 1–2, 2023. The Health Product Awards are open to the entire pharma industry and include two categories for eco-design and patient-centric design. The Exhibitor Awards celebrate excellence across three categories for drug delivery innovation, packaging innovation, and sustainability initiative.

In the eco-design category, Rotor Print was rewarded for taking an important further step for the packaging industry by developing a high-grade 100% PET blister that provides an equal barrier to the traditional aluminum lid or PVC.

The award for patient-centric design went to ATB-West for Latentogram, which combines a holographic label incorporating a latent image, invisible to the naked eye, with a credit card-sized handheld viewer. Idevax and Voxdale were Highly Commended in the same category for the development of VAX-ID, a patented drug delivery device platform developed for intradermal injection.

In the Exhibitor Innovation categories, Owen Mumford Pharmaceutical Services won the drug delivery innovation category for its UniSafe reusable connected auto-injector.

In the packaging innovation category, PACKSYS GmbH was chosen for its ampoule dispenser system, which is a combination of ampoule breaker, body, and screw thread.

Finally, Körber Pharma Packaging Materials won in the sustainability initiative category for its plastic-free Rapid Covid Test, which is made solely of recyclable cardboard mono material and is biodegradable.

Pharmapack Europe has announced the winners of the 2023 Pharmapack Awards spanning five categories across two dedicated awards. 

Pharmapack Europe Announces Winners of Pharmapack 2023 Awards

Roche, a Swedish biotechnology company, announced on Feb. 7, 2023 positive data from its Phase III study (COMMODORE 2) evaluating the efficacy and safety of crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, in people with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood condition that causes the complement system to destroy red blood cells. The treatment is for PNH patients who have not been previously treated with complement inhibitors.

According to a company press release, crovalimab is designed to control PNH via a subcutaneous injection every four weeks. In this study, crovalimab met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis, or the ongoing destruction of red blood cells. Study results indicated that the drug achieved disease control and was non-inferior to eculizumab, a current standard of care given intravenously every two weeks.

“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche, in the release. “As the first global [P]hase III data for crovalimab, these results emphasize its potential to address these needs. We look forward to submitting these data to regulatory authorities, bringing us one step closer to making crovalimab available for people with PNH around the world.”

Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.