Quality by design

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."

Eurofins CDMO Alphora Inc. (Canada) Announces the Launch of its Biologics Initiative focusing on mAbs and Therapeutic Proteins

Retrieved on: 
Wednesday, October 4, 2023
Science, Other Science, Biotechnology, Pharmaceutical, Medical Supplies, Health, Infectious Diseases, Other Health, Therapy, Quality by design, OTF, Bioprocess engineering, Hook effect, API, Design of experiments, Hadwen Arboretum, Documentation, Biopharmaceutical, CGMP, Map, Doe, Safety, Fine chemical

Eurofins CDMO Alphora Inc. is pleased to announce the launch of its Biologics initiative, as part of its vision to diversify and grow within the contract development and manufacturing industry in North America.

Key Points: 
  • Eurofins CDMO Alphora Inc. is pleased to announce the launch of its Biologics initiative, as part of its vision to diversify and grow within the contract development and manufacturing industry in North America.
  • The multiphase initiative aims to establish a facility at the 2070 Hadwen site within the Sheridan Research Park campus in Mississauga, ON, Canada.
  • The $6.3M investment by Eurofins CDMO Alphora is supported by a $2.5M grant from the Ontario Government through the Ontario Together Fund (OTF).
  • Further, Eurofins CDMO Alphora’s existing API and HPAPI expertise in linker and warhead development and manufacturing will help support clients with antibody drug conjugate candidates.

Premier Research Fortifies Cell and Gene Therapy Leadership Team, Strengthening End-to-End Capabilities in Complex Asset Development

Retrieved on: 
Monday, April 17, 2023
Pharmacy, Central nervous system, CGT, Gene, Quality by design, Pediatrics, CMC, NMES, Strategic planning, RNA, CNS, DSM-IV codes, Metabolism, Inborn errors of metabolism, Dermatology, Documentation, FACMG, Aloba, Hematology, Regulatory affairs, Cardiology, Research, TGA, FDA, Neurology, Meyer, Safety, Medical device, Pharmaceutical industry, EU, Cell

MORRISVILLE, N.C., April 17, 2023 /PRNewswire/ -- Premier Research announced today the addition of Kenneth Ndugga-Kabuye, M.D., FACMG, as VP, Cell & Gene Therapy to the strategic Cell & Gene Therapy (CGT) Leadership Team. Ndugga-Kabuye joins experts Jessica Merryfield, Executive Director, Cell & Gene Therapy, Olu Aloba, Ph.D., VP, CMC Services and Greg Meyer, VP, Regulatory Affairs in addressing the complexities of CGT development, as evolving regulatory receptivity creates a supportive environment for innovation.

Key Points: 
  • Cell and Gene Therapy Expert Dr. Kenneth Ndugga-Kabuye to Lead
    Clinical Strategy With Collaboration From Operations, CMC and Regulatory Experts
    MORRISVILLE, N.C., April 17, 2023 /PRNewswire/ -- Premier Research announced today the addition of Kenneth Ndugga-Kabuye, M.D., FACMG, as VP, Cell & Gene Therapy to the strategic Cell & Gene Therapy (CGT) Leadership Team.
  • "The speed at which agency guidance is changing, coupled with complicated cell and gene therapy study logistics, is creating demand for early, in-depth strategic planning," Premier Research Chief Operating Officer Michael Arlotto, Ph.D., said.
  • "Cell and gene therapy approval pathways are highly variable among regulatory agencies globally," Ndugga-Kabuye said.
  • Jessica Merryfield, Executive Director, Cell & Gene Therapy, who has more than 20 years of clinical research experience, including more than 10 years specializing in CGT.

Global Process Analytical Technology Market Report 2022: Growing Healthcare Spending by Pharmaceutical & Biopharmaceutical Firms to Drive Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 15, 2022
Software, Research, Hardware, Pharmaceutical, IOT (Internet of Things), Technology, Health Technology, Science, Nanotechnology, Biotechnology, Other Technology, Health, Other Science, Chromatography, Raman, Cros, Contract research organization, Nuclear magnetic resonance, Quality by design, Drug development, CDMO, PAT, USD, Cram, Coal analyzer, Spectroscopy, FTIR, NMR, Product-service system, Growth, NIR, Fine chemical, Vibrational analysis with scanning probe microscopy

The "Global Process Analytical Technology Market, by Technology (Spectroscopy, Chromatography), Measurement (On-line, In-line, At-line), Product & Service (Analyzers, Probes, Sensors), End User (Pharmaceutical Manufacturers, CROs, CDMO) - Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Process Analytical Technology Market, by Technology (Spectroscopy, Chromatography), Measurement (On-line, In-line, At-line), Product & Service (Analyzers, Probes, Sensors), End User (Pharmaceutical Manufacturers, CROs, CDMO) - Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.
  • A growing number of pharmaceutical & biopharmaceutical R&D activities and technological advancements resulting in process optimization are the key factors driving the growth of the market.
  • However, the shortage of skilled professionals and the high cost of PAT deployment are hindering the market growth.
  • Based on application, the process analytical technology market is broadly segmented into small molecules, large molecules, manufacturing applications, and other applications.

ValGenesis and QbD Pharmaceutical Services Partner to Deliver Best-in-Class Quality by Design and Process Validation and Verification Services for Life Sciences Companies

Retrieved on: 
Friday, September 30, 2022
Engineering, Knowledge management, Digital technology, GxP, Efficiency, U.S. FDA, QBD, PDA, Compliance, Parenteral Drug Association, Partnership, Industry, Lean Six Sigma, Quality by design, Title 21 CFR Part 11, Risk management, Solution, ISEE, SAN, PAT, West Pharmaceutical Services explosion, GMP, Fine chemical

SAN FRANCISCO, Sept. 30, 2022 /PRNewswire/ -- ValGenesis, Inc and QbD Pharmaceutical Services have partnered to deliver best-in-class quality by design and process validation and verification services for the life sciences industry across Europe and South America.

Key Points: 
  • SAN FRANCISCO, Sept. 30, 2022 /PRNewswire/ -- ValGenesis, Inc and QbD Pharmaceutical Services have partnered to deliver best-in-class quality by design and process validation and verification services for the life sciences industry across Europe and South America.
  • QbD Pharmaceutical Services S.L, founded in 2015 in Barcelona, delivers high added-value services and specialized outsourcing solutions to pharmaceutical and biopharmaceutical companies.
  • In this partnership, QbD Pharmaceutical Services will implement and manage next-generation digital risk management, process validation verification tools developed by ValGenesis, enabling clients to further strengthen quality by design and process validation and verification across the GMP lifecycle.
  • QbD Pharmaceutical Services delivers high value-added services and specialized outsourcing solutions to pharmaceutical and biopharmaceutical companies.

North America Bioanalytical Testing Services Market Report 2022: Rising Demand for Analytical Testing of Biologics and Biosimilars & Increasing Preference for Outsourcing Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 9, 2022
Pharmaceutical, Science, Health, Other Science, Molecule, Quality by design, Country, Adoption, COVID-19, Fine chemical

The "North America Bioanalytical Testing Services Market 2021-2031 by Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Country: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "North America Bioanalytical Testing Services Market 2021-2031 by Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Country: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering.
  • The North America bioanalytical testing services market is projected to grow by 8.3% annually in the forecast period and reach $3,232.3 million by 2031, driven by the rising demand for analytical testing of biologics and biosimilars amid COVID-19 pandemic, increasing preference for outsourcing analytical testing, growing R&D expenditure in the pharmaceutical and biopharmaceutical industries, and the rising adoption of the Quality by Design (QbD) approach.
  • In-depth qualitative analyses include identification and investigation of the following aspects:

Asia Pacific Bioanalytical Testing Services Market to Grow at 11.2% Through 2031 Reaching $13.35 Billion - ResearchAndMarkets.com

Retrieved on: 
Friday, July 29, 2022
Neurology, Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, Infectious Diseases, Molecule, Country, Adoption, Asia-Pacific, Quality by design, COVID-19, Fine chemical

The "Asia Pacific Bioanalytical Testing Services Market 2021-2031 by Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Country: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Asia Pacific Bioanalytical Testing Services Market 2021-2031 by Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Country: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering.
  • Asia Pacific bioanalytical testing services market will grow by 11.2% annually with a total addressable market cap of $13,359.1 million over 2022-2031, driven by the rising demand for analytical testing of biologics and biosimilars amid COVID-19 pandemic, increasing preference for outsourcing analytical testing, growing R&D expenditure in the pharmaceutical and biopharmaceutical industries, and the rising adoption of the Quality by Design (QbD) approach.
  • In-depth qualitative analyses include identification and investigation of the following aspects:

ARM and NIIMBL Release Project A-Cell To Bring Quality By Design Principles To Cell-Based Therapy Manufacturing

Retrieved on: 
Tuesday, July 26, 2022
University college, Antibody, Gene therapy, GLOBE, Industry, Chimeric antigen receptor T cell, National Institute, Workforce, Technology transfer, FDA, VAX 9000, ARM, Science, Cancer, Patient, Lymphatic system, CMC, Quality by design, Regenerative medicine, Vaccine, Pharmaceutical industry, Chemistry

Many of the hurdles to the streamlined, cost-effective manufacture of cell and gene therapy products derive from a lack of standardized methodologies and training around CMC programs.

Key Points: 
  • Many of the hurdles to the streamlined, cost-effective manufacture of cell and gene therapy products derive from a lack of standardized methodologies and training around CMC programs.
  • A-Cell emulates previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene).
  • A-Cell focuses on an autologous CAR-T therapy because of early regulatory successes and significant investor interest in this therapeutic approach.
  • We are very excited about the project because cell therapies have demonstrated a transformational impact on patients, said Gene Schaefer, NIIMBL senior fellow.

Process Characterization & Statistical Modeling -- Transforming Data into Knowledge Throughout the Product Lifecycle, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, July 12, 2022
Knowledge, Data management, Associate, Food, Quality by design, R, Risk, Knowledge management, Algorithm, Doe, Workflow, Product lifecycle, JMP, Industry, Drug development, Doctor of Philosophy, Process, Risk management

TORONTO, July 12, 2022   /PRNewswire-PRWeb/ -- It's no surprise that data plays a pivotal role in the biopharmaceutical industry. Parsing through the large amount of valuable data acquired during a product lifecycle and turning it into actionable knowledge is a critical task for drug development pre- and post-regulatory approval. At Cytovance Biologics, process characterization not only characterizes activities in the process validation landscape, but also provides a platform leveraging enablers that turn data into product and process knowledge. This ensures desired product quality and process consistency start to finish.

Key Points: 
  • In this free webinar, learn about a process characterization platform that leverages enablers that turn data into product and process knowledge.
  • At Cytovance Biologics , process characterization not only characterizes activities in the process validation landscape, but also provides a platform leveraging enablers that turn data into product and process knowledge.
  • In this webinar, the featured speaker describes their process characterization services based on Quality by Design (QbD) principles, emphasizing risk and knowledge management and transforming data into the currency of product and process knowledge.
  • For more information, or to register for this event, visit Process Characterization & Statistical Modeling Transforming Data into Knowledge Throughout the Product Lifecycle.

Global Bioanalytical Testing Services Market to 2031 - Trend Forecast and Growth Opportunities - ResearchAndMarkets.com

Retrieved on: 
Friday, April 8, 2022
Biotechnology, Science, Health, Research, Molecule, Adoption, Research, Quality by design, COVID-19, Fine chemical

The "Global Bioanalytical Testing Services Market 2021-2031 by Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Region: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Bioanalytical Testing Services Market 2021-2031 by Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Region: Trend Forecast and Growth Opportunity" report has been added to ResearchAndMarkets.com's offering.
  • The global bioanalytical testing services market will reach $7,902.9 million by 2031, growing by 9.1% annually over 2021-2031, driven by the rising demand for analytical testing of biologics and biosimilars amid COVID-19 pandemic, increasing preference for outsourcing analytical testing, growing R&D expenditure in the pharmaceutical and biopharmaceutical industries, and the rising adoption of the Quality by Design (QbD) approach.
  • This report is based on a comprehensive research of the entire global bioanalytical testing services market and all its sub-segments through extensively detailed classifications.
  • The report is based on studies on 2018-2021 and provides forecast from 2022 till 2031 with 2021 as the base year.