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If by using acronyms are we hiding behind our fears of not having command of processes? I wonder.
Batch vs. Continuous Pharmaceutical Manufacturing | General Kinematics
I am sure many glorified acronyms can be and have been created for simple mundane things. Governments have many such acronyms. I would not be surprised if a completely meaningless sentence could be written with many acronyms that only a handful of government employees will actually understand, no pun intended. However, sometimes, as said earlier, self-examination of things has value and simplifies life. Total command of the executed process is expected.
Each process has to have the same footprint no matter when and who produces the product. It is well known that lack of first time quality is expensive. While the progress of intermediates and final product as they travel the reactive or formulation process, are tracked using various process controls and analytical methods that have become more sophisticated and accurate with time; the fundamental premise has not changed in more than 80 years. Incorporation of statistical methods started in the 60s and their use has progressed over time. Again, chemists and chemical engineers are taught and suggested their use in the process development and design.
My point is that routine methods and criterions that are necessary in every process to produce quality product have just been given a fancy name: PAT.
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Its use is just camouflaging something simple with more complexity, creating the illusion that it is the necessary magic that will produce quality. Many still struggle to understand and incorporate these expectations in their process designs. Chemists and chemical engineers are expected to design processes that will produce quality from the get go and should not be told to do so. Anything short generally will result in economic disaster as monies and time are expended to bring off-spec product to quality or disposal unless associated costs are passed on to the customers.
Their process designs follow their protocol and their design is justified on the basis of the product need. Pharmaceuticals—active pharmaceutical ingredients API and their formulations—are mostly produced using batch processes. From the beginning of organic chemistry, organic chemicals have been produced using batch processes.
Such processes are the easiest to practice in the laboratory while being the simplest to understand and commercialize to produce the needed product. An important fact, the needed product volume, cannot be overlooked. Small quantities of active ingredients—generally milligrams—are needed by patients. Campaigns of exact similar chemistry products could be an exception but require strategic review.
Except for few handfuls of active ingredients e. Quality by Aggravation can be an operating norm. Conversion yields of such processes are not optimum.
Significant effort and investment is required for safety and environmental compliance; and Supply chain and inventory turns compared to other businesses are extremely low, e. The formulation of APIs in a dispensable dose is mostly done using batch processes. My conjecture is that this practice is based more on tradition than economics. The above outlined effects impact batch formulation processes and profitability.
It is ironic that the equipment technologies used for formulations have been in existence for more than sixty years and are used for continuous formulations by the fine and specialty chemical industry but have been avoided for pharmaceutical formulations. A recent unsubstantiated claim has been made regarding the continuous manufacture for a drug 5 that has extremely limited demand and can only be economically produced using batch process. Such claims defy engineering and business logic. Some publications and conferences that dreaded the words continuous manufacturing have suddenly embraced it to impress everyone.
I am not sure if the economics and reality of the process is really understood. Process technology and economics need to be answered and addressed 6 for the plants that can produce an API continuously or formulate it continuously. As I suggested earlier that very few APIs—probably less than 10—can be produced using a continuous process. There are many drugs that can be formulated continuously but require justification and an absolute command of the process. Technologies—blending, controlled mass-feeders, etc.
Feedback process controls that have been designed, developed and used for more than 60 years have to be tested for each product. Mid-course correction in blending and tableting operations impact product specs and performance and have to be precise and understood. Up and down side of technologies Again, for continuous processes to succeed there has to be complete and repeatable command of every process condition, unit operation, and operating parameter that influences product quality.promo.archidelivery.ru/components/iphone-7/goerueme-kayit-defteri.php
Continuous manufacturing: Offering flexibility and greater process control
Most of the discussion related to pharmaceutical manufacturing centers around formulations. API manufacturing is ignored and I feel it is considered a necessary orphan that just happens to be an intruder in the landscape. We have to recognize that without an API we do not have a drug.
For a continuous formulation process supply of consistent quality raw materials to operate the process producing the same drug, about 7, hours per year is a must. Actually the investment could be considered a waste.
With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered.
The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems. If you do not receive an email within 10 minutes, your email address may not be registered, and you may need to create a new Wiley Online Library account. If the address matches an existing account you will receive an email with instructions to retrieve your username.
Skip to Main Content. First published: 5 December About this book With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes.
Author Bios Dr. Ganapathy Subramanian is a biotechnology consultant with over 30 years experience in industry and academia, encompassing the application and development of processing, purification methodologies, and chromatographic systems for largescale use in environmental science, food science, perfumery, cosmetics, and pharmaceuticals. He has also taught extensively in the area of food and medical technology. A chemistry graduate from Madras, India, Dr. Subramanian was awarded his doctorate, from the University of Glasgow, for work on natural products.
His main research interests lie in the utilization of natural material separation processes and bioconversions.
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