Pharmaceutical Technology Editors

Steriline’s VFCM100, a vial-filling and capping machine equipped with a double-wall isolator, is a solution designed to increase contract development and manufacturing organization production capacity for COVID-19 vaccines. The machine is capable of reaching a production capacity of 6000 pieces per hour and was specifically developed for injectable drugs. It is equipped with four peristaltic pumps to allow for infinite filling capacity and 100% check-weighing. The machine can handle glass vials from 2 mL to 100 mL, and can also handle plastic vials via a format change.

The double-wall isolator is included to guarantee sterility throughout the aseptic filling process, minimizing the risk of product contamination. Once vials are capped, they are moved via conveyor belt into a printer where every cap is marked with the relative batch details for tracking purposes.

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Steraline’s VFCM100 guarantees sterility throughout the aseptic filling process via a double-wall isolator. 

Double-Isolated Vial-Filling Machine

ACP Systems’ quattroClean snow jet technology is a cleanroom-compatible cleaning process that is dry and uses liquid, climate-neutral carbon dioxide (CO2). Upon impact with the surface that is to be cleaned, the four effects (thermal, mechanical, solvent, and sublimation) of the technology are designed to remove filmic contaminants and particles to the sub-micron range effectively and consistently. Additionally, because the crystalline CO2 sublimates completely during cleaning, the surfaces or parts are dry following the process.

ACP tailors the process for full-surface or partial cleaning in tests at companies’ technical centers based on factors such as device application, material properties, the type of contamination, and cleanliness specifications. This testing influences various process parameters, including volume flows for compressed air and CO2, the number of nozzles, the area to be jet-cleaned, and the jet time.

During cleaning, end-to-end process monitoring is used to validate the cleaning via specific process parameters. Media preparation equipment is used to prevent cross- and re-contamination of surfaces.

ACP Systems’ quattroClean snow jet technology uses liquid, climate-neutral CO2 for cleanroom cleaning.

CO2-based Cleaning Jets

Linkam Scientific Instrument's NEXUS Software

Linkam Scientific Instruments’ NEXUS software is used to precisely control and record all aspects of heating, cooling, vacuum, humidity, and other environmental conditions in Linkam stages. NEXUS Core is the main NEXUS platform, which includes various specifications to enable a greater degree of experimental control. The software features a live display, allowing for real-time observations, adjustments, and precise synchronization between samples in parallel with a real-time temperature chart.

In addition to the CORE platform, optional modules also exist. The NEXUS Image Capture Module, for instance, facilitates automatic image capture during experiments. Each image can be stamped with current temperature and other parameters, and the device also has rewind and review capabilities that can be used during live data recording. Other modules include the Extended Measurements module, the Reporting module, the Thermal Analysis by Surface Characterization (TASC) module, and the 21 

Linkam Scientific Instruments’ NEXUS software enables holistic environmental controls in experiments. 

Environmental Control Software

Catalent announced on Dec. 1, 2022 that it has completed the expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China.

The expansion increased the facility by approximately 30,000 ft2, which has allowed for the installation of additional refrigerated and deep-frozen storage, as well as expansion of secondary packaging capabilities. The completion of the facility will be marked by two events on Dec. 1 and Dec. 6, 2022, where the facilities at the site will be showcased and workshops on clinical supply management and new GMP policies will be held.

The Waigaoqiao facility is one of two clinical supply facilities that Catalent operates in Shanghai; the other is located in Tangzhen, outside of the FTZ. The two facilities provide sponsors with optimized supply solutions for studies being undertaken in China, the Asia-Pacific region, and globally. These include clinical supply management, comparator sourcing, FastChain demand-led supply, primary and secondary packaging, storage, and global distribution, as well as clinical returns and destruction.

“China is the fastest growing clinical trials market in the Asia-Pacific region, and Catalent continues to invest and expand its facilities and services to offer reliable, flexible, and integrated support to customers,” said Tracey Clare, general manager, APAC Operations, Catalent, in a company press release. “These additional capabilities increase the site’s ability to support clinical trials for advanced therapeutics, which often require specialized storage and handling capabilities.”

Catalent has completed the expansion of its clinical supply facility located in Shanghai, China. 

Catalent Completes Expansion of Clinical Supply Facility

Eisai and Biogen announced results from Eisia’s global Phase III confirmatory Clarity Alzheimer’s disease (AD) clinical study of lecanemab on Nov. 29, 2022. Lecanemab is an investigational anti-amyloid beta protofibril antibody intended for the treatment of mild cognitive impairment (MCI) stemming from AD and mild AD (also known as early AD) with confirmed presence of amyloid pathology in the brain.

The study was a placebo-controlled, double-blind, parallel-group, randomized study of 1795 people with early AD in North America, Europe, and Asia. According to a company press release, the primary endpoint was change from baseline at 18 months in the clinical dementia rating sum of boxes (CDR-SB), a global cognitive and functional scale.

The mean change of CDR-SB in patients who received lecanemab was 1.21, while patients who received placebo had a mean change of 1.66, which the researchers found to be highly statistically significant. Key secondary endpoints, such as reduction in amyloid plaque burden, slowed decline of cognitive function on the Alzheimer’s disease assessment scale–cognitive subscale, and a decline of daily living activities, also showed statistically significant responses relative to placebo.

“Today’s exciting results offer our best hope yet for not only delaying symptom progression for people with early stage Alzheimer’s, but, significantly, slowing the loss of quality of life for them and their carers,” said Dr Richard Oakley, associate director of research, Alzheimer’s Society, in an agency press release concerning the findings.

Results from Eisai and Biogen’s Alzheimer's treatment, lecanemab, indicated significantly slowed cognitive decline in patients relative to placebo.

Eisai and BioGen Alzheimer’s Drug Shows Promising Results in Phase III Study

Merck, known as MSD outside of the United States and Canada, and BigHat BioSciences, a biotechnology company specializing in machine learning (ML)-guided antibody discovery and development, announced a research collaboration on Nov. 29, 2022 in which Merck will use BigHat’s Milliner platform to design candidates for up to three drug discovery programs.

According to a company press release, the Milliner platform combines high-speed characterization with ML capabilities to engineer antibodies with more complex functions and better biophysical properties. The goal of this approach is to reduce the difficulty of optimizing antibodies and other therapeutics.

“We are excited to begin this collaboration to advance next-generation antibody therapeutics to patients,” said Elizabeth Schwarzbach, chief business officer, BigHat, in the press release. "This agreement with Merck brings us a major step closer to our goal of [three to five] deep collaborations with leading biopharma [companies] to complement our internal therapeutic pipeline."

“This agreement with BigHat expands Merck’s strategy of applying AI [artificial intelligence]/ML across our drug discovery capabilities,” said Juan Alvarez, vice-president of Biologics Discovery, Merck Research Laboratories, in the release. “We look forward to working with the team to leverage BigHat’s technology and expertise in enabling molecular design of novel biologic candidates."

Merck will use BigHat’s AI/machine learning-enabled platform to design candidates for up to three drug discovery programs.