Good laboratory practice

Veranex Acquires Leading Pathology and Histology Provider HORUS Scientific

Retrieved on: 
Wednesday, May 1, 2024
Pathology, Growth, Engineering, DVM, GLP, Acquisition, Histology, Good laboratory practice, Knowledge

RALEIGH, N.C., May 1, 2024 /PRNewswire/ -- Veranex, the first purpose-built, integrated global service platform for the medtech industry, announced that it has acquired HORUS Scientific, a pathology and histology facility. This acquisition further solidifies Veranex's global commitment by deepening its end-to-end service capabilities for medtech innovation.

Key Points: 
  • "The growth of Veranex is a direct result of unwavering commitment to our clients' success," said Pat Donnelly, Chairman and CEO of Veranex.
  • "By joining forces with HORUS Scientific, we are not only expanding our footprint but enriching our collective expertise, strengthening our histology service capabilities, and enhancing the value we bring to our clients and partners."
  • "HORUS is excited to join the Veranex team — an organization with an outstanding reputation," said Dr. Stanley.
  • The additional capability added in North America will complement Paris's globally integrated in-house pathology and histology services, strengthening Veranex's overall pathology service line.

Synedgen Completes IND-Enabling Studies for Two Parallel Programs for Lead Asset MIIST305

Retrieved on: 
Thursday, April 25, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Mortality, FDA, Ulcerative colitis, Radiation, Drug discovery, Safety, MD, Trial of the century, Doctor of Philosophy, IND, Disease, Patient, Chemistry, CMC, GLP, Physician, Good laboratory practice, Toxicology, UC, Pharmaceutical industry

Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced it has completed IND-enabling studies for its lead candidate, MIIST305.

Key Points: 
  • Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced it has completed IND-enabling studies for its lead candidate, MIIST305.
  • MIIST305 is being developed for two parallel programs, an indication for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS).
  • Within a year, Synedgen plans to open an Investigational New Drug (IND) application for MIIST305 and initiate a Phase 1 clinical study to support both programs.
  • Synedgen was awarded a $4.4 million grant from the Congressionally Directed Medical Research Program (CDMRP) to fund some of MIIST305’s preclinical, IND-enabling studies.

TATAA Biocenter Achieves GLP Accreditation for qPCR and dPCR

Retrieved on: 
Tuesday, April 16, 2024
CRISPR, Laboratory, Safety, Pharmacokinetics, AAV, Growth, PCR, Real-time, Therapy, ISO/IEC 17025, Accreditation, GCLP, GLP, TATAA, Nested polymerase chain reaction, Messenger, Good laboratory practice, Good, Medicine

GOTHENBURG, Sweden, April 16, 2024 /PRNewswire/ -- TATAA Biocenter announced today that it has been awarded Good Laboratory Practice (GLP) accreditation. The accreditation represents a crucial step in the company's strategic progression into a market leading molecular analysis contract research organization (CRO) expediting biopharmaceutical innovations in advanced therapies and precision medicine.

Key Points: 
  • This important milestone for TATAA Biocenter provides customers access to safety testing, accelerating the transition of promising therapies from laboratory research and preclinical testing to clinical applications.
  • GOTHENBURG, Sweden, April 16, 2024 /PRNewswire/ -- TATAA Biocenter announced today that it has been awarded Good Laboratory Practice (GLP) accreditation.
  • With the addition of GLP accreditation to its existing Good Clinical Laboratory (GCLP) compliant work and ISO/IEC 17025 accreditation, TATAA Biocenter is now positioned to support clients through all development stages and regulatory filings.
  • "As one of few laboratories with GLP accreditation for qPCR and dPCR, we can now support the pharmaceutical industry in a comprehensive way and accelerate the process through even more robust analyses, allowing therapies to reach the patient faster, " said Mathias Hallin, CEO of TATAA Biocenter.

TATAA Biocenter Achieves GLP Accreditation for qPCR and dPCR

Retrieved on: 
Tuesday, April 16, 2024
CRISPR, Laboratory, Safety, Pharmacokinetics, AAV, Growth, PCR, Real-time, Therapy, ISO/IEC 17025, Accreditation, GCLP, GLP, TATAA, Nested polymerase chain reaction, Messenger, Good laboratory practice, Good, Medicine

GOTHENBURG, Sweden, April 16, 2024 /PRNewswire/ -- TATAA Biocenter announced today that it has been awarded Good Laboratory Practice (GLP) accreditation. The accreditation represents a crucial step in the company's strategic progression into a market leading molecular analysis contract research organization (CRO) expediting biopharmaceutical innovations in advanced therapies and precision medicine.

Key Points: 
  • This important milestone for TATAA Biocenter provides customers access to safety testing, accelerating the transition of promising therapies from laboratory research and preclinical testing to clinical applications.
  • GOTHENBURG, Sweden, April 16, 2024 /PRNewswire/ -- TATAA Biocenter announced today that it has been awarded Good Laboratory Practice (GLP) accreditation.
  • With the addition of GLP accreditation to its existing Good Clinical Laboratory (GCLP) compliant work and ISO/IEC 17025 accreditation, TATAA Biocenter is now positioned to support clients through all development stages and regulatory filings.
  • "As one of few laboratories with GLP accreditation for qPCR and dPCR, we can now support the pharmaceutical industry in a comprehensive way and accelerate the process through even more robust analyses, allowing therapies to reach the patient faster, " said Mathias Hallin, CEO of TATAA Biocenter.

Global gRNA Market to Surpass USD 1.62 Billion by 2030 with Robust Growth in Next-Generation Sequencing and Genome Engineering Applications - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Pharmaceutical, Genetics, Health, Growth, Gene editing, NGS, Research, RNA, Lead, Massive parallel sequencing, Guide, Good laboratory practice, IND, Medicine, Inde, Investment, CRISPR, USD, GLP, Pharmaceutical industry

The global gRNA (guide RNA) market is witnessing an unprecedented surge, with projections estimating its growth to reach USD 1.62 billion by 2030, expanding at a compound annual growth rate (CAGR) of 18.6% from 2024 to 2030.

Key Points: 
  • The global gRNA (guide RNA) market is witnessing an unprecedented surge, with projections estimating its growth to reach USD 1.62 billion by 2030, expanding at a compound annual growth rate (CAGR) of 18.6% from 2024 to 2030.
  • The latest market report on the global gRNA industry, now available for review, emphasizes the utility of products and custom gRNA synthesis services, and the ever-expanding realm of research applications.
  • Pharmaceutical and biotechnology companies are leveraging gRNA to pioneer advancements in precision medicine, positioning themselves as key end-users and market growth propellants.
  • The integration of advanced technologies and the discovery of novel applications are key to sustaining this growth momentum.

B&C and Acta Announce Appointment of Mark J. Washko as Senior Government Affairs Advisor, and Alexander E. Howard and Michelle C. Mims to Science Team Positions

Retrieved on: 
Friday, March 1, 2024
National Association, Reno 1868 FC, Commerce, Molecular biology, Consultant, University, ASTM, House, Biophysical chemistry, Energy, EPA, Legislation, Public policy, Representative, Good laboratory practice, Advisory board, Committee, Environmental justice, Federation, College, Bowling Green State University, Quality assurance, Corteva, Majority, Biophysical environment, BASF, Environment, OECD, Business network, TSCA, Sunscreen Innovation Act, Charles River Laboratories, Government, Organization, GLP, Frank, Bachelor, Society, B&C, Policy, American Chemistry Council, Management

WASHINGTON, March 1, 2024 /PRNewswire-PRWeb/ -- Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce the appointment of several professionals to key roles at our firms.

Key Points: 
  • (B&C®) and The Acta Group (Acta®) are pleased to announce the appointment of Mark J. Washko, Alexander E. Howard, and Michelle C. Mims to key roles at our firms.
  • (B&C®) and The Acta Group (Acta®) are pleased to announce the appointment of several professionals to key roles at our firms.
  • Mr. Washko, Mr. Howard, and Ms. Mims join a powerful team of advocates, scientists, and regulatory and business consultants at B&C and Acta.
  • Mr. Washko, Mr. Howard, and Ms. Mims join a powerful team of advocates, scientists, and regulatory and business consultants at B&C and Acta.

Sapio Sciences Announces Full GxP Validation of its Unified Lab Informatics Platform and Suite of Solutions

Retrieved on: 
Thursday, January 11, 2024
Software, Research, Networks, Pharmaceutical, Data Management, Apps, Applications, Technology, Health Technology, Security, Science, Biotechnology, Health, Other Science, ISO/IEC 27001:2013, HIPAA, GLP, ELN, GCP, Documentation, GxP, GMP, Good manufacturing practice, Accreditation, SOC, Good laboratory practice, Safety, LIMS, Medical device

Sapio Sciences , the science-aware™ lab informatics platform , today announced that its unified platform for research and clinical informatics has been validated to comply with “good practice” quality guidelines and regulations.

Key Points: 
  • Sapio Sciences , the science-aware™ lab informatics platform , today announced that its unified platform for research and clinical informatics has been validated to comply with “good practice” quality guidelines and regulations.
  • GxP refers to good practice quality guidelines and regulations that span various industries, including pharmaceutical and biotech companies and contract development and manufacturing organizations (CDMOs), which Sapio’s platform serves.
  • In addition to validating its software, Sapio has also developed a premium validation package for its customers.
  • Visit the Sapio website for a guide reviewing the impact of GxP on life science organizations.

LadRx Issues 2024 Update to Shareholders

Retrieved on: 
Tuesday, January 9, 2024
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, LADR, Hand, Toxicology, Zebra, GMP, Sale, OTCQB, Good laboratory practice, IND, Food, Human, NDA, Therapy, Investigational New Drug, New Drug Application, Patent, Pharmaceutical industry

LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, today issued the below letter to shareholders providing a corporate update and anticipated milestones for 2024 regarding arimoclomol and LADR-7.

Key Points: 
  • LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, today issued the below letter to shareholders providing a corporate update and anticipated milestones for 2024 regarding arimoclomol and LADR-7.
  • On January 8, 2024, Zevra announced the acceptance of the arimoclomol NDA by the FDA, with a Prescription Drug User Fee Act (“PDUFA”) date of June 21, 2024, triggering a $1 million payment obligation from XOMA to LadRx.
  • The second milestone related to arimoclomol is the first commercial sale of arimoclomol by Zevra, which triggers an additional $1 million payment from XOMA to LadRx (which will net LadRx $600,000).
  • We look forward to continuing to build on our momentum at LadRx and a successful 2024.

Eurofins Scientific Announces the Acquisition of Quasfar, Establishing a Presence in Colombia and Expanding the Presence of Eurofins Laboratories in Latin America

Retrieved on: 
Thursday, November 16, 2023
Other Health, Pharmaceutical, Other Natural Resources, Agriculture, Natural Resources, Fitness & Nutrition, Cosmetics, Retail, Science, Veterinary, Biotechnology, Health, Other Science, Acquisition, Good laboratory practice, Food, History, Life, Laboratory, Pharmacology, Technical report, LATAM, Environment, TAT, Pharmaceutical industry, Fine chemical, Eurofins Scientific

Known as Eurofins Quasfar going forward, the laboratory represents the first Eurofins laboratory in Colombia and is a leading pharmaceutical, veterinary and cosmetic product testing laboratory, with over 26 years of experience, employing over 100 employees.

Key Points: 
  • Known as Eurofins Quasfar going forward, the laboratory represents the first Eurofins laboratory in Colombia and is a leading pharmaceutical, veterinary and cosmetic product testing laboratory, with over 26 years of experience, employing over 100 employees.
  • Based in Bogotá, Colombia, the 1,680 m² laboratory is equipped with state-of-the-art testing equipment, technology and information platforms and systems, and is certified in Good Laboratory Practices for pharmaceutical quality control laboratories, under the guidelines of WHO Technical Report Series, No.
  • The origins of Eurofins’ presence in Brazil dates back to 2001, when Eurofins Genescan established its presence in Brazil, setting up an office in São Paulo/SP, shortly followed by the opening of a laboratory.
  • 900 laboratories in 61 countries, Eurofins offers a portfolio of over 200,000 analytical methods.

424 Capital Announces Investment in VaLogic

Retrieved on: 
Wednesday, November 29, 2023
Calibration, Research, GLP, GMP, Organization, Biotechnology, Capital, Therapy, Good laboratory practice, HEPA, Software, Partnership, Software as a service, Growth, Good, Pharmaceutical industry, Fine chemical, MD

WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD.

Key Points: 
  • WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD.
  • The partnership with 424 Capital is an important milestone in VaLogic's business growth and expansion plans.
  • "424 Capital seeks to invest in important mission-driven companies, and VaLogic provides vital technology and services to clients in the life science and biotechnology sectors.
  • The partnership between VaLogic and 424 Capital is expected to have a significant impact on early-stage life science and biotechnology companies, expediting research, product development, and production.