Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
With the importance of monitoring and verifying pressure conditions as well as humidity and temperature measurement data in its cleanrooms, this automation, management and monitoring solution offered a consistent solution for technical facility management and thus the prerequisite for cost-optimized plant operation.
Density measurement is a powerful and important method to ensure in-process control (IPC) and quality control of final products in pharmaceutical production facilities.
Anton Paar's Generation M density meters and Abbemat refractometers deliver accurate and repeatable measurement results while providing system security for 21 CFR Part 11 compliance.
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
Biologic drugs, including monoclonal antibodies are revolutionizing the treatment of human diseases. There are nearly 60 antibodies that are approved and over 300 or more biologic drugs are at various stages of drug development. And with the improved efficacy and growing number of disease targets for biologic drugs, these numbers are likely to continue to increase.
Many organizations in the pharmaceutical and biopharmaceutical industries have increased their efforts in biotherapeutic drug development to remain competitive by shifting their activities away from small molecule toward biologics drug development.
Recent US and EU serialization mandates have introduced the GS1 DataMatrix barcode symbology into a much wider role in the pharmaceutical supply chain. While linear barcodes have served as identifiers for SKU- and lot-specific information, the more compact GS1 DataMatrix is now being used as the designated carrier for the greater amounts of data needed to authenticate and track each bottle and carton of prescription drug product. As the role of the DataMatrix has expanded, so has the need to read it consistently and reliably throughout the supply chain.
Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. Get the latest on novel protein modification platform and its application to generate ADCs, including new conjugation chemistries and linkers.