As the evolution of the global pharmaceutical industry continues to drive the need for more flexibility and lower costs, continuous manufacturing becomes an even more appealing and sensible option. However, despite the tremendous promise of its economic and quality control benefits, there are still many concerns about the regulatory landscape for continuous manufacturing. Dr. Christine Moore, executive director and global head of chemistry, manufacturing and control (CMC) policy at Merck, recently discussed the company’s pursuit of worldwide approval of continuous manufacturing for solid oral dosage products and what regulatory risks it sees as potential roadblocks.
Solvent removal is an essential process for sample preparation across a range of applications in many industries. Many sample formats and solvents are used with no single technique providing a universal solution, but despite the variety of specifics evaporation is well-understood and relatively uncomplicated. But while evaporation is an intrinsic step in so many applications it’s rare to find an evaporation expert in a laboratory, and many facilities use systems that are slow and cumbersome simply because they have always been used.
Compression tooling and tablet press manufacturers are faced with ongoing challenges in the tablet manufacturing environments. Providing support in all aspects of the tablet compression process should be expected from your tooling and tablet press partner. These services should include: press operator training, maintenance/calibration services, quick delivery of replacement parts, tooling, tablet design and powder formulation support.
CMOs are now providing more early development support to their customers as well as offering fully integrated services, including specialized services such as aseptic fill-finish. Growth of the full-service contract development and manufacturing organization (CDMO) market has enabled a paradigm shift from early biotechnology companies that wanted to become “fully integrated pharmaceutical companies” to today’s nimble, lean, and sometimes virtual companies.
This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.
One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.
There is a saying: Go big or go home. But not when dealing with sample testing of pharmaceutical powders. Then the saying is: Waste not, want not. In the cutthroat world of Big Pharma, staying one step ahead of the competition is imperative. Research to create the next new drug is a costly endeavor. Once a new product is developed, speed to market is the next challenge.
To demonstrate the process by which a placebo formulation was designed for an oral solid dose product that would be dispensed to the patient as a fast-dissolve tablet. The tablet is added to water and the resulting solution is dosed as a antibiotic mouthwash. Placebo matching was required not only for the tablet but also for the solution which the patient took.
In this case study, API (X) is a highly insoluble compound with a particle size of approximately 14 microns and targeted as a powder for oral suspension dosage form.
To observe, using carbon-13 nuclear magnetic resonance (13C-NMR), the effect of dilute acid and pepsin on gelatin crosslinks, induced by addition of 13C-enriched formaldehyde (13CH2O) to an aqueous gelatin solution.