List of projects implemented with European funds
Located in the heart of Europe & EU
Our headquarters is based in central Poland, 1.5 hours’ drive from the Warsaw airport. As one would anticipate from an EU based CDMO, we guarantee the highest levels of production and analytics standards for your business. Additionally, our “can-do” approach to our clients’ needs offers solutions to unforeseen challenges which we overcome as a team.
Read what’s happening at Mabion and in the world of biologics.
A case to remove redundant trials of biosimilars reaches FDA
The calls to reduce the scope of clinical trials of biosimilars are slowly reaching regulatory agencies. The FDA has just announced a new initiative to make trials more effective and useful, which, among others, will discuss the usefulness of confirmatory clinical studies of biosimilars.
Remote FDA inspections: new guidance released
The FDA has recently published a new draft guidance describing the remote oversight tools used for pre-approval evaluation of manufacturing facilities. The published regulations are expected to reduce the time to approval and facilitate the availability of innovative, generic and biosimilar drugs. The introduced oversight tools will also help agency to stay operational during the […]
Quantitation of monoclonal antibodies in serum
The complexity and diversity of monoclonal antibodies requires the use of optimized bioanalytical assay platforms during their pre-clinical and clinical development. Regulatory requirements for non-clinical and clinical data, especially for pharmacokinetics (PK) assessment, are becoming increasingly restrictive.
Popular obesity drug cuts the risk of heart attacks and strokes
Semaglutide (Ozempic) has been found to reduce the risk of cardiovascular events in obese people.
FDA approves first ustekinumab biosimilar
FDA approves first ustekinumab biosimilar Ustekinumab (Stelara®), a blockbuster monoclonal antibody originally developed by Janssen Pharmaceuticals, has just got a biosimilar counterpart. The new biosimilar, Wezlana®, manufactured by Amgen, received FDA approval in all indications of the originator, which include plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The FDA also granted it an […]
Another win for antibody-drug conjugates in breast cancer
Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 antigen, was reported to increase survival in HR-positive, EGFR2-negative breast cancer.
Updated Novavax’s COVID vaccine effectively neutralizes…
Novavax’s vaccine for 2023-24 season induced neutralizing responses against newly emerging subvariants EG.5.1 and XBB.1.16.6. in in vivo models.
Market welcomes the arrival of new RSV vaccines
The FDA has approved novel vaccines preventing the grave complications of RSV infection.
Mabion signs contract to purchase new bioreactors…
Mabion purchased a set of Xcellerex XDR bioreactors with conventional mixing technology.