QuTEM Receives GMP Certificates and Manufacturing Permits for Transmission Electron Microscopy Laboratory from the Swedish Medical Products Agency
17 Mayo 2024 - 1:00AM
QuTEM Receives GMP Certificates and Manufacturing Permits for
Transmission Electron Microscopy Laboratory from the Swedish
Medical Products Agency
QuTEM AB (formerly Vironova BioAnalytics AB), a leading provider of
transmission electron microscopy (TEM) services, proudly announces
the receipt of GMP (Good Manufacturing Practice) Certificates and
Manufacturing Permits for Independent Quality Control Laboratories
issued by the Swedish Medical Products Agency (Läkemedelsverket).
QuTEM is thereby authorized to perform critical quality control
analysis essential for the release of medicines to the market. The
GMP Certificates and Manufacturing Permits cover medicinal and
investigational medicinal products for both human and veterinary
use.
GMP regulations are formal standards established by regulatory
bodies worldwide to ensure the quality, safety, and efficacy of
pharmaceutical products. Manufacturing Permits for Independent
Quality Control Laboratories are granted by the Swedish regulatory
authority since January 2024 to laboratories that conduct tests
directly impacting the release of medicines. The GMP certificates
and manufacturing permits are a testament to QuTEM's commitment to
biopharma drug development and quality control through cutting-edge
electron microscopy technology.
As quoted on the GMP certificates by the Swedish Medical
Products Agency, QuTEM enables: "Quality control of micro- and
nanoparticles through transmission electron microscopy (TEM) with
the techniques of staining (negative stain) and freezing
(cryogenic) and with semi-automatic particle detection and analysis
using software". The endorsement from regulatory authorities
underscores QuTEM's position as a trusted partner in the
pharmaceutical industry, equipped to meet stringent regulatory
requirements.
Dr. Josefina Nilsson, CEO of QuTEM, expressed enthusiasm about
the achievement, stating, "QuTEM's predecessor, Vironova
BioAnalytics, made history as the world's first and only GMP
certified electron microscopy laboratory in 2020. Since then, we
have been providing GMP level TEM services. To this moment, we
proudly maintain our position as the only provider of electron
microscopy services holding a GMP certificate. Our clients are
consistently impressed by our advanced laboratory, top-tier
experts, and high service standards. They benefit through the
preparation of accurate and reproducible image datasets, the
generation of reliable quantitative data, and the robust
conclusions from the analysis. Acquiring the GMP certificates and
manufacturing permits signifies not only a seamless transition in
business and quality assurance from Vironova BioAnalytics to QuTEM,
but also showcases our adaptability in maintaining quality
standards amidst evolving regulatory requirements."
For more information about QuTEM and its GMP certified electron
microscopy services, visit www.qutem.com.
Contact information
Josefina Nilsson, Ph.D.CEOjosefina.nilsson@qutem.com+46 76 109
01 91
About QuTEM
QuTEM offers market-leading and unique analysis to researchers,
developers and manufacturers of advanced therapeutics. QuTEM has an
impressive range of clients across academia, SME biopharma
companies, big pharma, CDMOs and CROs. With a commitment to quality
and precision, the company supports pharmaceutical companies in
their research, development, and quality control efforts.
QuTEM's unique capabilities include:
- Offering an extensive service portfolio including a wide range
of analyses e.g., AAVs, adenoviral vectors, lentivirus, VLPs, LNPs,
liposomes, etc., to support biopharma needs.
- Highly accurate determination of capsid size distribution,
going far beyond full/empty analysis and providing highly accurate
measurements of capsid content down to numbers of kilobase
pairs.
- GMP compliance: QuTEM has been granted the GMP certificates by
the Swedish Medical Products Agency in April 2024. All
workflows, software and data handling are performed with full GMP
compliance.
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