Manufacturing
CLINICAL MANUFACTURING ON TIME AND WITHIN BUDGET
The key to successfully developing and shepherding a drug to the approval stage and beyond lies in careful planning right from the start of development Any and all issues that may arise during the process should be considered during this planning phase
Dissolution Prediction of Polymer-Coated Multiparticulates using In-Line Process Analytical Technology
Process Analytical Technology PAT is a mechanism for measuring and controlling process performance parameters and Critical Quality Attributes CQAs with the goal of ensuring final product quality Comprehensive implementation of PAT can compensate for process variability within normal operating conditions to ensure process and product quality is mana...
GEP MODELS FOR SCALING UP WET GRANULATION PROCESSES IN PLANETARY MIXERS
Wet Granulation WG process is a critical step for the production of many pharmaceutical dosage forms During this stage a liquid usually water is combined with a blend of active ingredients and excipients to form homogeneous granules with suitable properties to further processing The establishment of the end point of the wet granulation process i...
Multifunctional Nanoparticles for Check Point Inhibition and CAR-T Therapy
Rational of Reprogramming TumourImmune System The important role of our immune system is to recognise the foreign substance from the healthy cells and eliminate the foreign object from the body while maintaining the normal cells unharmed To do this the body immune cells such as lymphocytes and monocytes utilise unique check point molecules which...
USHERING IN THE FUTURE OF PHARMA
3D Printing opens the doors of possibility for pharmaceutical and medical device industries
Pharmaceutical manufacturers and consumers alike can look forward to a rapid evolution in the way medicine is manufactured and brought to market New possibilities in D printing are opening doors for both pharmaceutical research and applications such as personalised drug dosing complex drug release profiles and even bio printing The implications are...
Residence Time Distribution (RTD) Model
Novel applications to continuous pharmaceutical manufacturing
The Residence Time Distributions RTD can be determined experimentally through the injection of a tracer material into the process in the form of a pulse or a step To achieve this the outlet tracer concentration is measured until the effects of the injection settle down A key aspect to be considered during the experimental determination of resid...
Drug Concentration Assurance of Continuous Tablet Manufacturing
Advanced process control strategy
Currently pharmaceutical companies are going through a paradigm shift from conventional batch to Continuous Manufacturing CM process integrated with advanced automation and control system In CM Real Time Release Testing RTRT can be facilitated by the development of a highly efficient control system that can monitor and correct process variables in...
Pharmaceutical Crystallisation
Emerging process intensification technologies
Solution crystallisation is the formation of a crystalline solid state from a homogeneous solution Different methods exist to create the driving force for crystal nucleation and growth Common crystallisation methods are based on strategies to lower the solubility eg via cooling or the addition of a socalled antisolvent or to increase the solute con...
HPAPI Qualification Testing
Considerations in containment testing
Growing demand for High Potency Active Pharmaceutical Ingredients HPAPI and the rising prevalence of therapy areas such as oncology immunesuppressants and hormonebased products are fuelling the need for high potency handling capabilities As the use of high potency containment systems is rising manufacturers are looking at more innovative containmen...
System Engineering for a Novel Continuous Pharmaceutical Manufacturing Process
Pharmaceutical industries as well as regulators eg FDA are strongly promoting smarter Continuous Manufacturing CM Few pharmaceutical products have been recently approved by US Food and Drug Administration FDA to manufacture in continuous line and several others are on the way There are several advantages but also different scientific challenges for...
