This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times. CRB was able to help a biotech company improve their Global Documentation Change Control Process quickly and easily.
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.
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.
The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.
Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.
From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.
As compared to IV route, ODT can provide a convenient oral route of administration for proteins, peptides and vaccines. Join experts from Catalent for an overview of the challenges and opportunities in using ODT technology as a patient-centric drug delivery tool and get updates on the new developments in ODT technology including delivery of peptides and vaccines.
With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates and antibody-peptide fusion proteins.
The complex structure of Biologics, the nature of the interactions with their partners, require accurate modelling method to predict their physicochemical properties.
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.
