Pharmaceutical Technology Editors

The innovation deal between 908 Devices and Transcenta in mid-2018 has materialized into concrete improvements in workflow efficiency. By utilizing 908 Devices’ technologies at their manufacturing facility in Hangzhou, China, Transcenta has been able to facilitate their biopharma analytical workflows across large molecule characterization and formulation process development.

908 Devices’ ZipChip enables the rapid measurement of critical quality attributes (CQAs) of intact monoclonal antibodies (mAbs). By utilizing this technology, Transcenta was able to characterize intact mAbs and determine what was causing increases in acidic and basic variants when placed under stress at high temperatures. The antibodies were similarly analyzed in their intact state under native conditions as well as their subunit and peptide levels. Ultimately, the analysis helped determine heterogeneity speciation and identification in under ten minutes, which resulted in a workflow that was 100 times faster for Transcenta.

“Technologies offered by 908 Devices enabled us to quickly obtain high-quality analytical data to help accelerate development of innovative biologics to ultimately reach patients sooner. Our recently published results demonstrate the positive impact,” said Christopher Hwang, chief technology officer of Transcenta, in a press release from July 22, 2021. “ZipChip is a capable platform for multiple CQA assays, and, for charge variant analysis, it is very straightforward to get separation and identification information with minimal method development needed for different types of proteins, especially for the analysis in native conditions. The sample preparation is simple and straightforward, and the sample requirements are at nanogram level.”

In addition to the ZipChip, Transcenta also found success with 908 Devices REBEL technology. REBEL is designed to accelerate media and process development, both of which are critical in the development of highly intensified continuous cell culture perfusion platforms. REBEL was instrumental in getting Transcenta to a point where its volumetric production rate rose to more than 6 g/L per day. More specifically, it was crucial in their amino acid analysis.

“REBEL can analyze a large number of samples in a short period of time to provide valuable data to accelerate cell culture process development,” continued Hwang. “Rather than obtaining amino acid profiles after the run is completed, REBEL can provide near real-time data for us to make process decisions while the experiments are in progress to maximize successful outcomes.”

“The pharmaceutical industry recognizes that enhanced process understanding and control lead to improved yields and predictability. Our ZipChip and REBEL products enable that understanding by making bioanalysis fast and accessible,” said Kevin J. Knopp, CEO and co-founder of 908 Devices, in the press release. “The outcomes of our collaboration with Transcenta are encouraging and serve as a beachhead for our expanding work in the Asia Pacific region. We’re proud of the successful work and discoveries developing from the use of our products in this region.”

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Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.

908 Devices and Transcenta Partnership Leads to Workflow Innovations

Ziath, a UK-based instrumentation control and information management company focused on laboratory automation, in conjunction with the University of Hertfordshire, has discovered a means of using artificial intelligence (AI) to enable discrimination between empty wells in sample tube racks from wells that may have an obscured or poorly rendered barcode.

Ziath utilizes DataMatrix barcodes to track biological and compound samples. These barcodes are laser-etched onto the underside of sample tubes, which are then stored in racks. Tube identification is then done via a barcode reader that scans the bottom of the rack and decodes it.

A problem had emerged, however, where traditional barcode readers were sometimes unable to determine the difference between an empty well and those that have hard-to-read labels. This error can happen for various reasons, such as ambient lighting, background image lasering, or simple variation in barcode lasering and material.

Alexander Beasley, PhD, from the University of Hertfordshire, used his expertise in embedded systems design to develop a scanner that circumvents these issues. By utilizing a convolutional neural network (CNN) for feature extraction of images, Beasley has been able to successfully discriminate between empty and full wells.

The new technology is expected to launch in Ziath barcoded tube scanners by the end of 2021. In the meantime, Ziath has also implemented the technology in the latest version of its DP5 control software, offering customers the opportunity to try the new technology immediately.

“The CNN I have chosen is designed to be very lightweight, allowing for quick execution,” said Beasley, in July 8, 2021 press release. “When compared to the pre-existing heuristic methods, the CNN approach was almost ten times faster to execute with virtually 100% accuracy.”

“This is just the first deliverable from our collaboration with Alexander and the University of Hertfordshire team,” said Ziath Managing Director Neil Benn in the press release. “We are expecting this project to revolutionize the way we decode DataMatrix tubes and help us produce the next generation of faster, lighter, go-anywhere tube rack readers. It’s an exciting development that will, very soon, improve sample tracking and tracing for scientists everywhere.”

Through a partnership with the University of Hertfordshire, Ziath discovers means of using AI to detect empty wells in sample tube racks.  

Artificial Intelligence Facilitates Empty Well Detection 

Avantor’s new J.T.Baker robotic tips, a series of robotic tips designed for use in robotic liquid handling and research workstations launched in July 2021, are designed for a range of applications, including genomics, cell biology, and proteomic workflows. They come in two formats: conductive and clear.

The conductive tips are designed to minimize downtime and keep operations running smoothly. Small liquid volumes can be sampled with high precision and without contamination. Additionally, the Hamilton and Tecan-type tips can be used in many robotic stations.

The clear tips are built for both sample preparation and drug discovery applications. Because these tips are transparent, users can visually recognize when the product is foaming for sampling purposes.

The J.T.Baker robotic tips are the latest in Avantor’s line of automated precision plastics, and one of the first to be announced following the company’s recent acquisition of Germany-based Ritter (and affiliates), a manufacturer of high-quality robotic and liquid handling consumables, including conductive pipette tips, in June 2021. Each batch is independently tested to make sure there are no contaminants such as DNase, RNase, amphipathic tail-anchoring peptide, and pyrogens.

“Our new, high-quality J.T.Baker robotic tips help researchers get the reliable, repeatable results required to keep critical life sciences work moving forward,” said Rohit Shroff, senior vice-president of Global Lab Products at Avantor, in a July 12, 2021 company press release. Our tips provide customers the precision and reliability they need to support their dynamic requirements.”

Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.

J.T.Baker Robotic Tips from Avantor Offer Precision Workflow 

On July 27, 2021, Cytiva and Pall, two subsidiaries of Danaher Corporation, announced that they will be making a $1.5 billion-investment toward expanding their manufacturing capacity and services.

The companies also released detailed plans on how the investment will be spent. The largest single investment, $600+ million, will go toward chromatography resins. Part of the $600+ million will specifically go toward establishing a new manufacturing site in the United States. The new facility is intended to complement the manufacturing capabilities of their Uppsala, Sweden, plant. No final location has been announced at this time.

Of the remaining sum, $400 million is going toward cell culture media; $300 million toward single-use technologies; and $200 million toward continuing expansion work in various countries.

This investment is the latest in a series of expansion moves made by the companies. In September 2020, Cytiva pledged $500 million over the course of five years on global manufacturing efforts. Since that announcement, Cytiva has already used the money to build a new manufacturing facility in Shrewsbury, Mass., and a new cleanroom in Westborough, Mass.

Additionally, since the September 2020 announcement Cytiva acquired companies such as Vanrx Pharmasystems, GoSilico, and Intermountain Life Sciences. In the same timeframe, Pall acquired Austar and Precision NanoSystems. Pall also announced plans to build a new plant in South Carolina and struck a manufacturing deal with Exothera.

Over the past year, Cytiva has hired 2000 new employees. With these plans in mind, the company is anticipating hiring 2000 more over the course of the next two years.

Cytiva and Pall reinforce recent expansion efforts with a $1.5-billion dollar investment in new manufacturing facilities.

Cytiva and Pall Investing $1.5 Billion into Manufacturing Expansion

The ZenoTOF 7600 System, recently launched by Sciex in June 2021, is a mass liquid chromatography–mass spectrometry/mass spectrometry (LC–MS/MS) instrument that includes both Zeno trap and electron activated dissociation (EAD) fragmentation.

This new system enables scientists to better identify, characterize, and quantify molecules by generating data that has been previously unattainable, Sciex stated in a company press release. These capabilities are expected to help solve real analytical challenges and advance the development of new precision diagnostics and biotherapeutics.

Zeno trap pulsing delivers up to twenty times more sensitivity than traditional orthogonal time-of-flight technology, while EAD fragmentation can derive novel structural information from diverse compound types. With EAD fragmentation, the system can fully characterize individual lipids from a single spectrum, which can enable the discovery of novel lipid markers for cancer and inflammatory disease. EAD fragmentation also allows biopharma scientists to precisely detect and quantify protein glycosylation patterns and differentiate isomeric amino acids, which are both critical for ensuring that therapies are safe and do not produce adverse reactions.

Additionally, when compared to prior products, this new LC–MS/MS system can quantify up to 40% more proteins and analyze biobank samples five times faster, Sciex stated in the press release.

Sciex’s recently launched accurate mass instrument, the ZenoTOF 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.

Sciex’s New ZenoTOF 7600 Mass Instrument System Offers Increased Analytical Precision

Merck, known as MSD outside the United States and Canada, announced on July 16, 2021 that FDA approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by 

) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. Vaxneuvance is contraindicated for individuals with a history of severe allergic reaction (such as anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid.

 (pneumococcus) is bacteria that cause pneumococcal disease. Different strains of these bacteria are called serotypes. Invasive pneumococcal disease (IPD) occurs when the bacteria infect parts of the body that are usually free from germs. Approximately, 80% of adult IPD occurs in adults 50 years of age and older. Serotypes 3, 22F, and 33F significantly contribute to IPD, and serotype 3 is the leading cause of IPD in adults in the United States.

The approval of Vaxneuvance was based on data from seven randomized, double-blind clinical studies, which assessed safety, tolerability, and immunogenicity in adults. Clinical data showed that immune responses were not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes (assessed by opsonophagocytic activity geometric mean titers).

Immune responses for Vaxneuvance were superior to PCV13 for shared serotype 3 and for the two serotypes unique to Vaxneuvance, 22F and 33F. However, randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to PCV13 have not been conducted.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss and make recommendations on the use of Vaxneuvance in adults.

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.