SP Scientific Products has expanded its freeze dryer loader range with the launch of two new GMP compliant loading systems compatible with SP Hull LyoConstellation freeze dryers.
The two latest SP Hull Loaders are a Semi-Automatic Loader (SALS-30) and a high-speed Row-by-Row Loader (RxR-36) for fill-finish processing applications that include freeze dryers.
Designed for advanced aseptic pharmaceutical processes involving lyophilization, the company said these loader introductions offer flexible and innovative solutions for small to medium batch and high-speed full line aseptic vial handling applications.
SP Hull SALS-30 is designed to replace manual loading for medium and smaller batch applications (loading speeds up to 70 vials/minute). The SP Hull RxR-36 is a unique loading system for full line vial applications requiring higher-speeds and capable of accommodating loading speeds up to 400 vials per minute.
Gyros Protein Technologies and Cygnus Technologies are introducing a new immunoassay solution: the reagent detects host cell impurities from HEK 293 cells used in vaccine and viral vector manufacturing for cell and gene therapies.
The move is part of the next phase of the two companies’ on-going collaboration: the HEK 293 HCP Assay Reagent Set for Gyrolab is the first of a planned range of ready-to-use bioprocess impurity reagent sets optimized for use with the Gyrolab platform.
The partners said the new automated nanoliter-scale immunoassay solution supports fast development and streamlined process transfer, increasing productivity, providing speedier results with less hands-on time, and reduced sample volume and reagent consumption. It also enables researchers to generate more data in less time for a broader range of analytical applications, allowing faster decision-making, said the collaborators.
Mark Vossenaar, vice president, general manager, biopharmaceutical development division, Mesa Labs, Gyros’ parent group, said. “There is a real need for analytical tools that support fast turn-around time and small sample volume, to accelerate viral vector bioprocess workflows and reduce time to market. HEK 293 HCP Assay Reagent Set for Gyrolab is the first of this new, high quality range, and we hope to announce further releases in the near future.”
GEA said its new 'aseptic' separator line enables gentle processing of human and veterinary vaccines, monoclonal antibodies (mAb), e-coli, insulin, starter cultures and probiotic products, while the 'pure' line is used in applications with varying hygienic requirements such as nutritional supplements, therapeutic proteins, pharmaceutical extractions, and extracellular and intracellular enzyme recovery.
The equipment was developed, built and tested at the GEA Westfalia Separator plant in Oelde, Germany.
“The aseptic line stands for the highest hygienic pharmaceutical requirements. The pure line provides maximum variability and is perfectly tailored to the diverse process requirements of the biopharmaceutical industry. All functions for pharmaceutical cleanliness requirements such as an automatic CIP, SIP, simple validation and a high-end qualification package are included. In addition, with the help of the cGMP validation process, the pharma separators support GEA customers in their quality standard reviews.”
Bruker launched new products and methods for the MALDI Biotyper (MBT) platform at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2021, held earlier this month.
The MBP platform is designed to enable molecular identification of bacteria, yeasts and fungi. It uses a molecular approach based on specific proteomic fingerprints from bacterial strains. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology.
The company said the new MBT Lipid Xtract Kit (RUO) expands MALDI Biotyper’s microbial analysis capabilities to lipids fingerprinting and to rapid colistin-resistance testing.
Additionally, enhanced workflows include MBT FAST Shuttle IVD, a benchtop tool to standardize and optimize drying conditions for faster matrix crystallization and quicker drying of other droplet assays for sample preparation, and its new MBT Mycobacteria Kit (RUO), a preparation kit for mycobacteria after culture that allows fast sample preparation and safe inactivation by avoiding the need to boil mycobacteria samples, it said.
Bruker also announced that it has expanded the MALDI Biotyper Reference Libraries as well to cover more than 4,000 species: the MBT IVD Library has been expanded with 674 new species and now contains 3,813 species, while the MBT Mycobacteria (IVD and RUO) modules cover 182 Mycobacterium species, and the MBT Filamentous Fungi Suite (RUO) contains 247 species or species groups.
Meanwhile, its new IR Biotyper 3.1 software is said to connect MALDI Biotyper microbial species identification with IR Biotyper strain-typing results for hospital hygiene. The software is using classification tools based on artificial neural networks (ANN) to build models of known strains, serotypes or serogroups. Pre-defined models can be used for fast classification of unknown serotypes or serogroups, including Streptococcus pneumoniae, Listeria monocytogenes, Salmonella or Legionella pneumophila.
The software also includes new visualization tools to allow easier interpretation for classification or differentiation of strains, said the developer.
Dr Wolfgang Pusch, executive VP microbiology and diagnostics at Bruker Daltonics, commented: “We have expanded our capabilities in microbiology and infectious disease from testing protein signatures to research on lipids as a new molecular window for microbial analysis. Moreover, with the IR Biotyper 3.1 software our users can now use information on the microbial carbohydrate composition, another unique capability in microbial research and epidemiology.”
Thermo Fisher Scientific has launched the TSG Series General Purpose Laboratory Refrigerators and Freezers, designed to protect general research and clinical materials, with temperature ranges that address both short- and long-term storage requirements, including those for COVID-19 vaccines.
They are designed to maintain optimal, consistent cold storage performance, which the company said is of critical importance in research, clinical and industrial laboratories to preserve the viability of stored materials, as is the need to minimize energy consumption, heat output and noise levels to protect the environment and enable a pleasant workplace.
The equipment has been developed with sustainability at its core, said the producer. The storage systems consume significantly less energy and expel less heat than conventional units; they also use eco-friendly F-Gas-compliant R290 hydrocarbon refrigerants, and they are designed to offer whisper-quiet operation at less than 52 dbA, minimizing disruption of the work environment.
The refrigerators provide a temperature range of 2° to 10°C, while the freezers are suitable for use when storage at -12° to -25°C is required. Both the refrigerators and freezers are available in 400L, 700L and 1500L capacities, added the company.
