While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation within the company and serialization efforts in place?
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and contract manufacturing organizations (CMO) carefully select equipment, outline processes and deploy appropriate containment strategies. Read how partnering with a knowledgeable and experienced CMO for this important stage of a drug’s life cycle can reduces costs and timelines, and ensures the safety of employees, the environment and the patient.
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.
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. Without thorough and comprehensive testing data a biologics license application (BLA) for the manufacture of a biopharmaceutical for commercial distribution will invariably be denied by regulatory bodies such as the US FDA. AbbVie’s five-step process results in a thorough understanding of the biologic and process control strategies to ensure drug safety, purity, and potency at the commercial scale, and since it is much harder to implement changes post- commercialization, continued process validation is employed.
Understanding and being able to control granulation is essential to the production of high quality pharmaceuticals. Fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size therefore affording superior process reproducibility and better process control than many other granulation techniques.
The growing adoption of single-use (SU) in all process steps of cGMP clinical and commercial production requires enhanced assurance of supply and robust product performance. This innovative bioprocessing bag technology is designed to meet the new challenges of assurance of supply and consistent performance for every process step and application of biomanufacture.
The growing adoption of single-use technologies in all process steps of cGMP clinical and commercial production requires enhanced assurance of quality supply. Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.
The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.
With the uptake of single-use bags in cell culture processes, some manufacturers have reported inconsistent cell growth. Read how Sartorius has addressed the challenge of cell growth performance in single-use bags with their Flexboy® bags and new Flexsafe® platform.
Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.
|
|
|
|
|
|
|
|
|