Pharmaceutical Technology Editors

Novartis announced on Nov. 7, 2022 that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Cosentyx (secukinumab) alone or in combination with methotrexate for use in pediatric arthritic conditions. Specifically, the two types of juvenile idiopathic arthritis (JIA) conditions are enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

JIA is a progressive and debilitating autoimmune condition that is the most common type of arthritis in young people, with around 1,500 new diagnoses in the UK every year, according to a company press release. If left untreated, ERA and JPsA can lead to high levels of pain, joint swelling, and disability, with many young people continuing to have active disease well into adulthood. If properly managed, it is possible for patients to live with inactive disease and prevent the progression of rheumatoid arthritis, including hand, limb, and spine deformities.

“We are pleased to announce the news of marketing authorization for secukinumab in young people living with ERA and JpsA and are delighted that they will now have the possibility of accessing an additional treatment option,” said Marie-Andrée Gamache, country president, Novartis Innovative Medicines UK and Ireland, in the press release. “At Novartis, we are continuing in our aspiration to eliminate the disease burden for every person living with painful and debilitating long-term immunological conditions by leading in the commercial sponsorship of clinical trials and turbo-charging discovery with investments in data and digital technologies.”

Articles

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

UK MHRA Expands Cosentyx License

FDA published a draft guidance concerning sameness evaluations in abbreviated new drug applications (ANDAs) on Nov. 8, 2022. The guidance discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

In addition to general recommendations on demonstrating sameness, the guidance provides additional considerations for products like synthetic peptides and complex mixtures. The guidance also provides non-binding examples of active ingredient characterization in the drug product.

The draft guidance can be viewed in full 

. FDA is soliciting comments on the guidance through Jan. 8, 2022.

The latest guidance from FDA discusses recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug.

FDA Publishes Draft Guidance Concerning Sameness in ANDAs

Shimadzu, a laboratory instruments supplier, and University Medical Center Göttingen (UMG), announced a collaboration to develop new clinical laboratory methods. The focus of their research will be on using liquid chromatography-mass-spectrometry (LC-MS) for therapeutic drug monitoring (TDM) analysis. The collaboration is being performed under Shimadzu’s European Innovation Center program, which is designed to enable collaborations where outside experts can work with Shimadzu technologies.

According to a Oct. 27, 2022 press release, TDM tests, which measure the concentration of drugs currently in blood, have usually been done through an immunoassay, but LC-MS methods have recently grown in popularity due to advantages in strength and accuracy. However, complexity of sample preparation has prevented widespread adoption.

The collaboration will focus on developing Shimadzu's CLAM-2030, a fully automated sample preparation module for LC-MS. The device functions by placing blood collection tubes in position, wherein the module automatically performs sample pretreatment steps up to LC/MS/MS analysis. The collaboration aims to develop new methods for multiple target groups of drugs, as well as means of switching between these new methods easily and quickly.

The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.

Shimadzu and UMG Göttingen Enter Analytics Collaboration

MGI Tech, a provider of tools and technology for the life sciences sector, announced the opening of an overseas Customer Experience Center (CEC) in London on Nov. 3, 2022. The second such suite in Europe, the new London site is designed to provide local customers and partners first-hand experience with MGI’s various instruments. The company’s other European site, located in Riga, Latvia, opened its doors in late October.

According to a company press release, the center will be operated by partners from the BRC Genomics Facility at Imperial College, London. In addition to various MGI automation systems, the facility will host the United Kingdom’s first DNBSEQ-G400 sequencer, which is designed to facilitate metagenomic analysis, spatial transcriptomics, microbiome, spatiotemporal omics, whole genome sequencing, whole exome sequencing, RNA sequencing, and more.

“Our new CEC will allow easier access to our cutting-edge technology locally. It will also serve as a hub for visitors to come in and experience MGI’s platforms for hands-on workflow, for our field application scientists to perform experiments for demo application, validation, and field testing, as well as for internal and external trainings,” said Duncan Yu, President, MGI, in the release. “We at MGI are proud to support researchers and partners in the region to develop content with our automation and sequencing platforms.”

“The new CEC is an important link to the local research and diagnostic community, enabling new genomic discoveries and medical advances,” said Yong Hou, General Manager, MGI Europe and Africa, in the release. “It has been wonderful to witness how MGI’s developments are transforming research and diagnostics, and our technology* will continue to empower local customers and partners to serve a greater purpose.”

MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.

MGI and Imperial College London Establish Overseas Customer Experience Center in the UK

Scorpion Biological Services, a contract development and manufacturing organization focused on the development of biologic drugs, recently hosted the grand opening of its new San Antonio, TX facility. The new facility is designed for the development and manufacturing of clinical and commercial-scale biologics.

“After more than 18 months of tireless work, preparation, dedication from our excellent team, and support from the San Antonio community, we have finally arrived at this moment where we can cut the ribbon, open our doors, and get to work,” said David Halverson, president of Scorpion, in an Oct. 25, 2022 company press release. “This facility will be at the forefront of American biomanufacturing, developing clinical and commercial-scale large molecules, so we can help our clients bring their biologic innovations from the lab to the clinic and to the patients that need them.”

“This is an extraordinarily exciting milestone for our company,” said Jeff Wolf, founder and chairman, Scorpion, in the release. “Today, we checked off a major milestone with the grand opening of Scorpion’s San Antonio manufacturing facility. It is years in the making, and we are thrilled to get the real work started, right here, right now.”

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Scorpion Biological Services Opens San Antonio Biologics Facility

Gerresheimer, a provider of drug delivery systems, and Nelson Labs, a provider of microbiological and analytical chemistry testing, announced a strategic partnership on Oct. 31, 2022. Under the partnership, which is designed to reduce risk and time-to-market for primary packaging solutions for injectables, Nelson Labs will conduct extractables and leachables testing, toxicological risk assessments, impurity identifications, and biocompatibility testing of injectable primary container closure systems or components for Gerresheimer.

“With this agreement, [we] will be able to offer an extended service package to our pharmaceutical and biotechnological customers for their new drug development and product life cycle management,” said Jen-Edouard Rabier, director, Business Development, Gx Biological Solutions, Gerresheimer, in a company press release. We are now able to provide our customers the best selection of primary packaging systems (vials, syringes, and cartridges) made of glass or cyclic olefin polymer (COP) without any concerns about compatibility, stability, or safety of the drug product.”

“I am extremely pleased that Gerresheimer and Nelson Labs have taken this very important step forward in joining our forces to provide customers with stellar testing and expert advice in container/closure qualification,” said Piet Christiaens, scientific director, Nelson Labs, in the release. “This partnership is designed to help the pharmaceutical industry take full advantage of our scientific leadership, unique Compounds Screener Database, personalized support, and other resources that will be offered through this alliance.”

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.