Pharmaceutical Technology Editors

Owen Mumford, a medical device manufacturer, announced on May 4, 2022 that it has signed an exclusive agreement with Stevanato Group, a provider of drug containment, drug delivery, and diagnostic solutions, to manufacture the Aidaptus auto-injector. Aidaptus is a two-step, single-use auto-injector that can accommodate 1 mL and 2.25 mL prefilled glass syringes in the same base device.

Based on the agreement, components for the Aidaptus will be molded by Stevanato Group, which will also provide final and sub-assembly equipment. Stevanato Group will also offer pre-filled syringes to create final product for patient use. Owen Mumford and Stevanato will both assemble components for the auto-injector. According to the company, the collaboration will bring added value to customers and streamline device production.

“Aidaptus will help patients to self-administer their individual therapies using a simple and easy to use device,” said Adam Mumford, director of Owen Mumford, in a press release. “At the same time, this auto-injector can help to reduce complexity, minimize supply chain risk, and simplify final assembly for pharmaceutical and biotechnology companies thanks to its ability to adapt to different viscosity, syringe sizes, and fill volumes. Often during development or life-cycle management of injectable drug products, changes in these parameters can occur. Now for the first time, the device does not have to be changed as well.” 

"We believe this agreement is an important step in enhancing and growing the opportunities in our drug delivery systems portfolio as we broaden our capabilities in this key market. As we are constantly working with our customers to satisfy their needs, we continue to experience an increase in demand for auto-injectors. With this agreement, we will exploit the full breadth of Stevanato Group integrated capabilities being able to offer device manufacturing, assembly equipment, together with pre-fillable syringes and inspection systems," said Mauro Stocchi, chief business officer of Stevanato Group, in the release.

“Stevanato Group is an established company with an excellent reputation in the pharmaceutical industry,” said Michael Earl, director of Pharmaceutical Services at Owen Mumford. “It has deep expertise in molding and assembly operations and will be a reliable source of quality components for our Aidaptus auto-injector. Forming a collaboration with Stevanato Group will provide additional reach to enable more customers to benefit from the advantages of this innovative new platform.”

"The Aidaptus auto-injector platform combines ease of use for patients with faster time-to-market access for pharma organizations. We aim to be the strategic partner with which to develop innovative combination products as we continue the expansion of our integrated capabilities in the drug delivery space, and for this reason we are very excited to work with Owen Mumford and provide access to its exciting new auto-injector platform,” said Steven Kaufman, VP for Drug Delivery Systems at Stevanato Group.

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The two companies signed an exclusive collaboration agreement for the Aidaptus auto-injector.

Owen Mumford and Stevanato Group Collaborate on Auto-Injector

The International Society of Pharmaceutical Engineering (ISPE) announced on May 3, 2022 that it has released a new guidance document for the continuous manufacturing of oral solid dosage forms. 

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

 reviews unit operations used in continuous manufacturing and establishes equipment requirements for systems in an integrated process train. The guide also considers changes in physical and automation requirements that enable each unit to work together.

Continuous manufacturing has become more integrated in the development and production of pharmaceutical products. According to ISPE, this creates a demand for more modular and flexible systems and a wide range of products and production control strategies. The guide provides a resource for designing and integrating continuous processing equipment.

“Continuous manufacturing provides for a full range of product life cycle, from small volume clinical production to large volume commercial production, with minimization or elimination of scale up activities, all leading to Real Time Release. It offers potential safety benefits and requires a smaller facility footprint,” said Guide Co-lead Dave DiProspero, director of Pharmaceutical Process Technology, CRB, in a press release.

“This Guide is intended to serve as a comprehensive reference for continuous manufacturing of oral solid dosage forms, providing guidance for pharmaceutical companies, regulators, engineering firms, and vendors engaged in this emerging technology,” said Guide Co-lead Gregory Connelly, senior director, Continuous Manufacturing, Vertex Pharmaceuticals, in the release.

The guide reviews unit operations and establishes equipment requirements for continuous manufacturing of oral solid dosage forms.

ISPE Publishes Continuous Manufacturing Guidance

Standard BioTools, previously known as Fluidigm, announced the launch of the Hyperion+ Imaging System, a high-plex spatial imaging tool, in April 2022. Relative to the original Hyperion Imaging System, the Hyperion+ provides lower limits of detection, improved sample capacity, and quicker time to results.

According to an April 11 press release from the company, the system can process over 100 samples per week, approximately twice the speed of their current model. It also has a 1.6x lower limit of detection, enabling detection of dim markers, which can be important when analyzing the lower-expressing markers often used in translational studies.

The device allows for scanning of eight to over 40 targets in a single run and can easily be scaled to more than 100 targets. Additionally, by using an efficient, simple stain, image, and analyze workflow, it reduces expenses up to 10x relative to immunohistochemistry, which uses complicated cyclic immunofluorescence or digital profiling approaches, according to the release.

“Two critical challenges in realizing the full transformative potential of this remarkable technology are reducing the time to answer key biological questions and detecting important biomarkers that are expressed at low levels,” said Michael Egholm, CEO and president, Standard BioTools, in the press release. “The Hyperion+ Imaging System is designed to solve these challenges with faster time to results and a lower limit of detection than the current Hyperion Imaging System. These capabilities are key to quickly uncovering important spatial relationships with high-plex spatial imaging of 40-plus markers simultaneously at subcellular resolution.”

“My research group has been able to rapidly conduct exquisitely detailed phenotyping studies using the speed enhancements now available in the Hyperion+ Imaging System, which give us unprecedented insight into how cells within the tumor microenvironment function and interact with each other and the extracellular matrix,” said Bernd Bodenmiller, professor at the Department of Quantitative Biomedicine, University of Zurich, and at the Institute of Molecular Health Sciences, ETH Zurich, in the press release. “These insights are the foundation for innovating the next generation of cancer diagnostics and therapeutics and improving outcomes for patients with cancer.”

Standard BioTools’ new Hyperion+ Imaging System can process more samples and has lower limits of detection than their current product.

Standard BioTools Launches Hyperion+ Imaging System

Quanterix, a company specializing in biomarker analysis, announced that FDA has granted its Simoa neurofilament light chain (NfL) plasma test a breakthrough device designation. According to an April 22 press release from the company, the designation covers the devices use as a prognostic aid in assessing the risk of disease risk in patients diagnosed with relapsing-remitting multiple sclerosis (RRMS).

According to the release, the device is a digital immunoassay that quantitatively measures NfL in human serum and plasma. If used in conjunction with clinical, image, and laboratory findings, it could serve as an aid in identifying RRMS patients' risk of relapse within four years, allowing physicians to tailor an individualized therapeutic approach.

“For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options,” said Kevin Hrusovsky, chairman and CEO, Quanterix, and founder, Power Precision Health, in the press release. “Obtaining FDA breakthrough device designation for our plasma NfL MS test was a key objective for 2022. We are pleased to have the opportunity to work with [FDA] to help advance the Quanterix Simoa NfL test towards regulatory approval.”

Prior to this designation, a study from The Lancet Neurology used this plasma test to help establish a new method for identifying and interpreting values of serum NfL (sNfL) in individual MS patients. Additionally, it was referenced in at least 20 studies presented at the American Academy of Neurology’s 74th Annual Meeting.

“There has been an ever-growing body of research with the Simoa NfL blood test supporting NfL as a reliable biomarker for MS disease activity prognosis and treatment response monitoring,” said Mark S. Freedman, professor of neurology and director of multiple sclerosis research at the Ottawa Hospital, in the release. “[FDA’s] grant of [b]reakthrough [d]evice designation for this test has the potential to help the multiple sclerosis community further advance the optimal use of NfL measurements in both research and clinical practice aimed at more effective therapeutic management of the disease for the millions of patients suffering from the condition.”

This is the second test from Quanterix that FDA granted breakthrough device status—the company’s phospho-Tau 181 assay for Alzheimer’s disease also received the designation in 2021.

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

FDA Grants Quanterix Plasma Test Breakthrough Device Designation

 diagnostics company, recently announced new data on its Accelerate Arc Module and BC kit. Internal studies found that the kit demonstrated 94% or greater accuracy on positive blood cultures when compared to conventional matrix-assisted laser desorption/ionization (MALDI).

According to an April 25 company press release, one study seeded samples for 20 of the most prevalent organism species (totalling 100 isolates) that were incubated on a blood culture system (BD Bactec FX, BD). After flagging positive, the samples were then processed on the new ARC BC kit, and subsequently tested in triplicate on two MALDI systems (Bruker Biotyper, Bruker, and (Vitek MS, bioMérieux). The Arc-processed samples had an overall agreement of 100% with the Bruker Biotyper and 94% with the Vitek MS.

Another study, conducted with the Medical College of Wisconsin, processed 50 fresh positive blood cultures from the VersaTrek blood culture system on the Arc Module, which were subsequently tested in triplicate on the Bruker MALDI system. When comparing the results, it was found that the Arc enabled direct identification of microorganisms in 90% of blood cultures, with 100% agreement between the Arc and colony identification. Additionally, the Arc enabled identification in under 90 minutes, with less than five minutes of hands-on time.

“This data represents an important step in providing a workflow solution to help automate sample preparation for rapid and accurate microbial identification, saving hours of wait time and numerous manual steps to deliver results," said Shelley Campeau, co-author of the studies and director of Scientific and Clinical Affairs, Accelerate Diagnostics, in the press release.

Accelerate Diagnostics’ new blood culture kit demonstrated 94% or greater accuracy on positive blood cultures relative to matrix-assisted laser desorption/ionization (MALDI).

Accelerate Diagnostics Blood Culture Kit Demonstrates Increased Efficacy

The Office of Compliance in FDA’s Center for Drug Evaluation and Research has released the office’s 2021 Annual Report. The report focuses on the various successes of the agency in public health throughout 2021.

The report highlights key initiatives that had a direct impact on patient safety, including efforts to address the COVID-19 pandemic. Other areas of focus include addressing the opioid crisis, compounded drug quality, drug supply chain security, fraudulent and unsafe drugs, amongst others throughout 2021.

The Office of Compliance’s efforts regarding COVID-19 included shielding patients and consumers from unsafe, ineffective, and poor-quality drugs, including unsafe hand sanitizers and products fraudulently claiming to prevent, treat, or cure COVID-19. The office also took action to increase access to critical medicines used to treat patients with COVID-19, such as albuterol, oxygen, and propofol, as well as support the development of new therapeutics.

The use of alternative tools used when on-site inspections were prevented due to COVID-19 was also described in the report, focusing on reorganization to strengthen oversight of drug compounding and prevention of fraudulent, poor quality, and unsafe drugs. The Office of Compliance makes strategic and risk-based decisions that are guided by law and science to foster global collaboration, promote voluntary compliance, and take decisive and swift actions to protect patients.

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.