Process analytical technology

Japanese Multinational Biopharmaceutical Company Selects ValGenesis iRisk for Implementing ICH Q14 Framework

Retrieved on: 
Tuesday, March 12, 2024
Quality by design, Patient, MSAT, Software, Process analytical technology, PAT, Safety, ICH

SANTA CLARA, Calif., March 12, 2024 /PRNewswire/ -- ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a Japanese multinational biopharmaceutical company selected ValGenesis iRisk for implementing the ICH Q14 framework on Process Analytical Technology (PAT) analytical methods across its global manufacturing sites.

Key Points: 
  • SANTA CLARA, Calif., March 12, 2024 /PRNewswire/ -- ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a Japanese multinational biopharmaceutical company selected ValGenesis iRisk for implementing the ICH Q14 framework on Process Analytical Technology (PAT) analytical methods across its global manufacturing sites.
  • Already aware of ValGenesis' experience helping customers implement PAT tools, the company approached ValGenesis with a requirement to implement a structured framework covering the ICH Q14 guideline on Analytical Method Development, specifically for PAT.
  • ValGenesis Consulting will lead the implementation of the ICH Q14 framework via a thorough assessment of the customer's current analytical method development practices across its sites, propose a framework for ICH Q14 adoption using ValGenesis iRisk , build the case for the customer's product in ValGenesis iRisk, and train a group of key users within their global MSAT team on the utilization of the framework on ValGenesis iRisk with sandbox access.
  • With ValGenesis iRisk, our customer is assured of a risk-based Quality by Design (QbD) approach to highly compliant and cost-effective manufacturing."

Preliminary QIG Considerations regarding Pharmaceutical Process Models

Retrieved on: 
Tuesday, March 12, 2024
Scope, Comparison, EMA, RTRT, Outline, Algorithm, PQS, Continuity, Design of experiments, Complex, Therapeutic index, Thought, OOS, Overalls, IPC, Mechanical philosophy, Digital, GMP, Residence time, Risk, Documentation, European, Point, RTD, CQA, Element, Statistical process control, ICH, CHMP, European Medicines Agency, Risk assessment, Machine learning, Region, Acceleration, Medicine, Process analytical technology, Uncertainty, Guideline, Digital twin, PAT, Literature, Artificial intelligence, Reproduction, Risk management

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Key Points: 
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      Preliminary QIG Considerations regarding Pharmaceutical
      Process Models

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      Background

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      This Quality Innovation Group (QIG) document follows on from the first QIG Listen & Learn Focus

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      Group (LLFG) on Continuous manufacturing and the second QIG LLFG on Digital novel technologies,

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      held on 13 March 2023 and 12-13 October 2023 respectively.

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      It is recognised that regulatory expectations for process models in pharmaceutical manufacturing are

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      evolving; the intent of this document is to share QIG?s current thinking with stakeholders and seek

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      their comments.

    • This, in turn, supports adoption of advanced process

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      control strategies, continuous process verification, real-time process monitoring and optimisation, and

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      automated or even autonomous operation and management of manufacturing processes.

    • Process

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      models play an increasingly important role in process design and validation, in control strategies and

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      during manufacturing process lifecycle.

    • The expected outcome from the use of process models is

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      enhanced process understanding, (multivariate) monitoring and control, robustness, performance and

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      adaptability.

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      A model (in the context of pharmaceutical manufacturing) is a mathematical representation of a

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      physical or biological process or system.

    • Empirical models (e.g., multivariate models used for Statistical Process Control, regression models

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      derived from data collected from Design of Experiments), and

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      3.

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      Scope

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      This document addresses preliminary considerations (general principles) for process models, reflecting

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      the use of performance-based approaches in pharmaceutical manufacturing processes.

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      The scope of this document is limited to process models such as first-principle models, regression

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      models, system models, multivariate statistical process control models, and Machine Learning models

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      (ML).

    • Complex datasets need not be
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
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      submitted.

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      Of note, these are just examples.

    • Process validation for finished products ? information and data to be provided in regulatory submissions
      (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1)
      Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory
      submission (EMA/CHMP/BWP/187338/2014)
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      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      Some models may have a dual purpose e.g., used for process development and used as part of the

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      control strategy e.g., to set control limits.

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      Process validation (as described in the process validation guidelines) has an overarching role to ensure

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      that the process consistently delivers material of the intended quality.

    • Depending on the model risk, a model verification protocol may be requested,
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
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      including the model performance metrics and the manufacturing process IPC and CQAs that should be

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      followed, the respective acceptance criteria, the number of additional data (independent) that would be

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      used, and the monitoring period (parallel testing).

    • Preliminary QIG Considerations regarding Pharmaceutical Process Models
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908 Devices Reports Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Revenue Outlook

Retrieved on: 
Tuesday, March 5, 2024
Hardware, Chemicals, Plastics, Health Technology, Manufacturing, Consumer Electronics, Other Health, Technology, Pharmaceutical, General Health, Medical Devices, Other Manufacturing, Biotechnology, Science, Other Science, Research, Health, MASS, Process analytical technology, PAT, Growth, Expansion, Counterfeit, Webcast, Video game

The installed base grew to 2,853 devices with 139 devices placed during the fourth quarter 2023.

Key Points: 
  • The installed base grew to 2,853 devices with 139 devices placed during the fourth quarter 2023.
  • Gross profit was $7.3 million for the fourth quarter of 2023, compared to $5.9 million for the corresponding prior year period.
  • Operating expenses were $17.0 million for the fourth quarter of 2023, compared to $16.3 million for the corresponding prior year period.
  • 908 Devices will host a conference call to discuss the fourth quarter and full year 2023 financial results before market open on Tuesday, March 5, 2024 at 5:30 am Pacific Time / 8:30 am Eastern Time.

SentrySciences ParticleSentryAI Receives 2023 Pharma Innovation Award

Retrieved on: 
Wednesday, October 18, 2023
PAT, SME, AI, Aggregation, Process analytical technology, Software, Root cause analysis, Fine chemical, Medical imaging

LONGMONT, Colo., Oct. 18, 2023 /PRNewswire-PRWeb/ -- The Pharma Innovation Awards are an annual celebration of new technologies and services that help advance product quality, risk reduction and manufacturing efficiency. The awards seek to highlight companies who listen to the needs of the market and their customers, and as a result, have distinguished themselves as leaders in pharma equipment and technology. The awards will be showcased in Pharma Manufacturing's November issue.

Key Points: 
  • SentrySciences is proud to announce that our software product, ParticleSentryAI is a recipient of the 2023 Pharma Innovation Award.
  • LONGMONT, Colo., Oct. 18, 2023 /PRNewswire-PRWeb/ -- The Pharma Innovation Awards are an annual celebration of new technologies and services that help advance product quality, risk reduction and manufacturing efficiency.
  • ParticleSentryAI software brings AI and subvisible particle imaging technologies together to provide a foundation for protein aggregate control strategies in the development and manufacture of biologic drugs.
  • ParticleSentryAI leverages morphological and textural features encoded in each image to understand the causes of aggregation and deliver actionable data to limit their impact.

908 Devices Launches MAVERICK for Real-Time In-Line Monitoring of Multiple Bioprocess Parameters

Retrieved on: 
Monday, September 18, 2023
Biotechnology, Pharmaceutical, Health, Medical Devices, Immortalised cell line, TrafFix Devices, Inc. v. Marketing Displays, Inc., BPI, University, Medium (website), CET, Glucose, MAVEN, Process analytical technology, Marketing strategy, Department of Chemical Engineering, Imperial College London, University of Massachusetts Lowell, De novo, Marketing, Table, Cell culture, Machine learning, ISCB Senior Scientist Award, Artificial intelligence, MASS, Biomass, Chemical engineering, CPO, Medical device, Satellite navigation device, Statera BioPharma

MAVERICK is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required.

Key Points: 
  • MAVERICK is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required.
  • MAVERICK offers all the advantages of Raman spectroscopy without the cost and complexities associated with conventional spectroscopic methods.
  • MAVERICK’s purpose-built de novo models automatically process Raman spectra from a wide variety of culture media types and cell lines, delivering actionable process parameters or direct process control actions.
  • MAVERICK is part of 908 Devices’ suite of devices to help expedite bioprocessing development, including MAVEN – introduced earlier this year -- and REBEL .

Sartorius and Repligen Corporation Launch Integrated System with Biostat STR® and XCell® ATF for Upstream Process Intensification

Retrieved on: 
Thursday, August 17, 2023
Maintenance, Partnership, SCADA, Therapy, Senior, Control system, Controller, Perfusion, Distributed control system, Supervisory control, Process analytical technology, Repligen, Repligen Corporation Award in Chemistry of Biological Processes, ATF, DCS, PAT, Sartorius, Software, Fine chemical

Customers experience optimized facility equipment installation, footprint, and maintenance requirements

Key Points: 
  • Customers experience optimized facility equipment installation, footprint, and maintenance requirements
    WALTHAM, Mass., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Sartorius and Repligen Corporation (NASDAQ:RGEN) today announced the launch of an integrated bioreactor system that incorporates Repligen XCell® ATF upstream intensification technology into Sartorius’ Biostat STR® bioreactor, simplifying intensified seed train and N perfusion implementation for biopharmaceutical manufacturers.
  • The Biostat STR® now contains a fully compatible embedded XCell® ATF hardware and software module offering predefined advanced control recipes with integrated Process Analytical Technology (PAT).
  • The single, integrated controller provides easy integration into Supervisory Control and Data Acquisition (SCADA) and Distributed Control Systems (DCS).
  • “The market introduction of this integrated bioreactor–intensification system created in partnership with Repligen further reinforces Sartorius’ commitment to being an innovator in process intensification and demonstrates our expertise in upstream processing technologies,” said Mario Becker, Head of Product Group Bioreactor Technologies, Sartorius.

Bruker Announces SciY™ Platform of Advanced Scientific and Automation Software Solutions for the Digital Transformation of the Life Science and Biopharma Industries

Retrieved on: 
Friday, June 30, 2023
Technology, Research, Professional Services, Software, Biotechnology, Health, Data Analytics, Data Management, Science, Data management, BRKR, Bruker, Process analytical technology, Multimedia, Electronic lab notebook, Data analysis, Corporation, Acquisition, Mathematical optimization, PAT, AI, Automation, Medical device

Bruker Corporation (Nasdaq: BRKR) today announced the SciY™ platform of advanced, vendor-agnostic software solutions for data analysis, data management, research lab and bioproduction QC digitalization, and workflow automation in the life science industry and for biopharma companies.

Key Points: 
  • Bruker Corporation (Nasdaq: BRKR) today announced the SciY™ platform of advanced, vendor-agnostic software solutions for data analysis, data management, research lab and bioproduction QC digitalization, and workflow automation in the life science industry and for biopharma companies.
  • The new SciY platform combines and integrates high-performance lab software solutions for a more comprehensive, vendor-agnostic suite of software and automation solutions for life-science industry customers, primarily in the biopharma sector.
  • With its innovative, modular software solutions, the SciY product platform will streamline data acquisition, integration and interpretation, and enhance the value of data in life-science and biopharma research, development and manufacturing.
  • SciY encompasses a software portfolio of Electronic Lab Notebook solutions, analytical chemistry and biology solutions, Process Analytical Technologies (PAT), and scientific data management.

Single-cell Analysis Market worth $7.1 billion | MarketsandMarkets

Retrieved on: 
Thursday, June 22, 2023
Prevalence, Genomics, B cell, Merck Group, Biomedical Research, DiaSorin, Patient, Conditional sentence, Commercial, Automation, Tissue, Bio-Rad Laboratories, Single-cell analysis, Research, Infection, Gene expression, Danaher Corporation, Biology, Machine learning, Medicine, Growth, BD, DNA, Corning Inc., Genetics, Cancer, Cell, Biomarker, Becton, Dickinson and Company headquarters, Participation, Algorithm, Agilent Technologies, Flow cytometry, PAT, SME, Illumina, Inc., QIAGEN, Process analytical technology, Sartorius AG, Standard BioTools, RNA, Promega, Computation, Oxford Nanopore Technologies, Retail, Mobile phone, Video game, Pharmaceutical industry, Fine chemical, Marketing, Microscope

The research applications segment accounted for the largest share of the application segment in the single-cell analysis market in 2022.

Key Points: 
  • The research applications segment accounted for the largest share of the application segment in the single-cell analysis market in 2022.
  • Based on applications, the single-cell analysis market is categorized into two segments—medical applications and research applications.
  • The Asia Pacific region is estimated to grow at the highest CAGR in the single-cell analysis market during the forecast period.
  • Tracking the product portfolios of prominent market players helps to analyze the products in the single-cell analysis market.

Single-cell Analysis Market worth $7.1 billion | MarketsandMarkets

Retrieved on: 
Thursday, June 22, 2023
Prevalence, Genomics, B cell, Merck Group, Biomedical Research, DiaSorin, Patient, Conditional sentence, Commercial, Automation, Tissue, Bio-Rad Laboratories, Single-cell analysis, Research, Infection, Gene expression, Danaher Corporation, Biology, Machine learning, Medicine, Growth, BD, DNA, Corning Inc., Genetics, Cancer, Cell, Biomarker, Becton, Dickinson and Company headquarters, Participation, Algorithm, Agilent Technologies, Flow cytometry, PAT, SME, Illumina, Inc., QIAGEN, Process analytical technology, Sartorius AG, Standard BioTools, RNA, Promega, Computation, Oxford Nanopore Technologies, Retail, Mobile phone, Video game, Pharmaceutical industry, Fine chemical, Marketing, Microscope

The research applications segment accounted for the largest share of the application segment in the single-cell analysis market in 2022.

Key Points: 
  • The research applications segment accounted for the largest share of the application segment in the single-cell analysis market in 2022.
  • Based on applications, the single-cell analysis market is categorized into two segments—medical applications and research applications.
  • The Asia Pacific region is estimated to grow at the highest CAGR in the single-cell analysis market during the forecast period.
  • Tracking the product portfolios of prominent market players helps to analyze the products in the single-cell analysis market.

Thermo Fisher Scientific Completes Acquisition of MarqMetrix

Retrieved on: 
Wednesday, June 21, 2023
Other Health, Research, Pharmaceutical, Oil, Gas, Energy, Other Manufacturing, Science, Chemicals, Plastics, Biotechnology, Manufacturing, Other Science, Health, PAT, Polymer, Analytical chemistry, Acquisition, Thermo Fisher Scientific, Raman, Mindful Scientific Inc., Instrument, Process analytical technology, Management, Fine chemical

Thermo Fisher Scientific Inc., the world leader in serving science, has completed its acquisition of MarqMetrix, a privately held developer of Raman-based spectroscopy solutions for in-line measurement.

Key Points: 
  • Thermo Fisher Scientific Inc., the world leader in serving science, has completed its acquisition of MarqMetrix, a privately held developer of Raman-based spectroscopy solutions for in-line measurement.
  • “The acquisition of MarqMetrix is an excellent strategic fit for Thermo Fisher and adds highly complementary Raman-based in-line PAT to Thermo Fisher’s portfolio,” said Miguel Faustino, President, Chemical Analysis, Thermo Fisher.
  • We look forward to welcoming the MarqMetrix team to Thermo Fisher.”
    MarqMetrix has approximately 30 employees based in the United States.
  • MarqMetrix will become part of Thermo Fisher's Analytical Instruments segment.