Detection of mycobacterium species in qPCR as a consideration for cell banking testing in support of cell & gene therapy manufacturing
Eurofins enhances vaccine development services
The transitional provisions under Regulation (EU) 2017/745 (MDR), which are applicable for legacy devices already marketed under 93/42/EEC (MDD), will cease no later than 26 May, 2024. By this date, technical documentation for these devices must comply with the new requirements in order for the products to maintain CE certification. To close any gaps in technical documentation, Eurofins BioPharma Services Consulting Munich offers a new service that supports manufacturers by performing gap analyses of their entire technical documentation, and provides strategies and/or documentation to close the identified gaps.
Rouging is a corrosion phenomenon that occurs on stainless steels. It is commonly observed in compendial water, pure steam production, water distribution installations, and in manufacturing equipment. Although this problem is fairly frequent, its causes have not been completely elucidated and pharmacopeias have not given any recommendations. Therefore, users have to troubleshoot this widespread and complex phenomenon.
Eurofins Scientific (EUFI.PA), the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services, announces the completion of the acquisition of WESSLING Hungary.
Eurofins Discovery Announces Acquisition of DiscoveryBioMed
Like many consumers, Japanese society is typically very concerned by the contamination of products with foreign matters. For example, if a consumer found a foreign matter in their food, it would not be uncommon for this to immediately be taken up by the media and have a major impact on the manufacturer of the food. When it comes to pharmaceuticals, the impact can be even more severe, with some companies suspending the manufacturing of pharmaceuticals until the source of contamination has been formally identified, once a foreign matter has been found. It is therefore not only accuracy that is critical for foreign matter analysis, but also speed. Eurofins Analytical Science Laboratories, Inc. (E-ASL) has more than two decades of testing experience and has continually met the needs of clients by utilising a variety of analytical techniques customised for the type, size, and condition of foreign matters.
We all have a duty to play our part in efforts to protect the natural world and achieve sustainable climate objectives. In line with this perspective, Eurofins BioPharma Product Testing Europe has decided to promote and implement the International Standard ISO 14001 by introducing an Environmental Management System. Through earning the certification, sites were challenged to improve their environmental performance through more efficient use of resources and reducing waste.
20 years ago, Eurofins PSS began as a big experiment. A Virginia (VA), USA, client was experiencing a challenge: they needed to keep some testing in-house yet struggled with co-employment and performance challenges regarding temporary staff. They requested that the Eurofins laboratory in Lancaster, PA, reverse their service model and offer testing services at their VA site rather than outsource samples. So with innovation and passion to meet client needs, PSS was founded to recruit, hire, train and manage highly qualified scientists to perform laboratory testing services at the client’s site. And ever since, great chemistry was made.
Assuring the sterility of a parenteral drug product, prior to any human use, is a mandatory regulatory requirement. Sterile products should not contain contaminants caused by microorganisms, gases or debris, and the chosen Container Closure System (CCS) has to prevent the ingress of such substances throughout the entire shelf life. The ability of the CCS to maintain the integrity of its physical barrier, and hence the sterility of a drug product, has to be demonstrated through Container Closure Integrity Tests (CCIT).