LSNE Successfully Completes MHRA Inspection
Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.
The CMO Lyophilization Services of New England (LSNE) reports that its manufacturing facility in Bedford, New Hampshire has received a Certificate of GMP Compliance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture aseptic lyophilized drug products for use in the European Union. LSNE underwent an initial inspection in May 2013 and was found to be compliant with EU GMP with no critical or major findings. After completion of an audit and registration, LSNE was issued a Certificate of GMP Compliance of a Pharmaceutical Manufacturer from the MHRA. The Bedford facility is now certified for the manufacture of sterile lyophilized drug products to be marketed in the EU.
Source: LSNE
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
