From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.
Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.
Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.
If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.
An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.
Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.
We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?
Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are towards higher cell densities and protein titers.
Many existing research labs, pharmaceutical and biopharmaceutical manufacturers, and contract manufacturing organizations (CMO’s) are not designed nor are they equipped with the engineering controls to safely handle the manufacture of ADC’s. The safe manufacture of ADC’s requires more modern facilities, equipment, and engineering controls as well as programs, practices, and procedures to adequately protect the operators and the work environment. Read the steps that must be taken to consider a glovebox workstation fully validated to manufacture ADCs safely.
There are a number of reasons to choose LBDDS over conventional formulation approaches when working with poorly soluble compounds. However, the range of lipidic excipients and the abundance of factors that go into determining which combinations of lipids, cosolvents, and surfactants to select makes LBDDS a complex, formulation-dependent technology. Know what criteria to consider when selecting a CMO to handle LBDDS manufacturing.
Mixing is one of the most common operations in food processing, but comes with challenges -- batch-to-batch uniformity, optimizing blend times, and most importantly: improving cleanliness.
The Thermo Scientific AuditCheck metal detection verification performance system is a unique performance verification system which utilizes an automated test shuttle that moves through the metal detector’s field at user-specified points in time.
Purchase of new mixing equipment is typically not a hasty event. As with any capital investment, the purchase of a new mixing system ideally requires time and research.
Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.