• Complete documentation of the entire production process
- Batch Records
- Finished Goods Records
• Ability to source any materials required by the customer
• ISO 13485 12 years in a row
• Just-in-time (JIT) assembly for specific products
What is Bioprocessing?
Bioprocessing is the heterogeneous mixture of chemical, microbiological, and physical processes employed in the production of new materials from living or harvested cells, tissue, and organs. Bioprocess production is therefore the continuous-flow or batch process of breaking down cells, proteins, and collagen into desired products. Bioprocessing has existed since the beginning of the human race.
What is the Purpose of Bioprocessing?
The purpose of bioprocessing encompasses the ability to use living organisms or their natural products to create a reaction or chemical, often without the use of traditional chemical or organic methods. Bioprocessing is intended to be used for chemical reactions that were previously synthetically manufactured and not used in nature exclusively. Bacteria, fungi, and yeasts all fall under the bioprocessing category. within the living organism that will yield the desired end result. Its aim for troubled or unrefined feedstocks is transferred to commercially successful and safe ingredients for refining or for use in animal nutrition, medicinal treatment, medical therapy, and food additives.
Stages of Bioprocessing
The three main steps/stages in a bioprocess are upstream processing, fermentation, downstream processing.
- The upstream procedure is the first step in the bioprocess, beginning with early cell isolation and cultivation and continuing through cell banking and culture development until the required quantity is attained.
- Media preparation, cell culture, cell separation, and cell harvest are all included in upstream processing, which is the process of creating inoculum.
- Upstream biomanufacturing tries to grow the cells that will produce the desired protein, which will then be improved upon during downstream processing steps.
- The bulk of prokaryotes and unicellular eukaryotes produce their energy through anaerobic fermentation.
- In organisms like yeast, partial oxidation of glucose produces acids and alcohol, including pyruvic acid, which is then converted into ethanol and carbon dioxide (CO2).
- By dissolving glucose from enzymes, the process of glycolysis produces energy.
- The purification and recovery of biosynthetic products, notably pharmaceuticals, from natural sources like animal or plant tissue or fermentation broth, as well as the recycling of salvageable components and efficient waste handling and disposal, is referred to as downstream processing.
- In downstream processing, multi-step procedures are employed to recover and purify desired products.
- Enhancing product recovery while lowering production costs is the most crucial downstream processing objective from a business perspective.
What are the Types of Bioprocessing?
There are three primary types of industrial fermentation processes: batch, fed-batch, and continuous fermentation.
In a batch process, all nutrients are given at the start of the cultivation without any additional additions during the following bioprocess. Only control substances like gases, acids, and bases are added during the entire bioprocess; it is a closed system. The bioprocess continues after that until the nutrients are ingested. For quick investigations like strain characterisation or nutrient media optimization, this approach is appropriate. This convenient method's limitation in biomass and product yields is a drawback. The bacteria often do not spend a long time in the exponential growth phase since the carbon source and/or oxygen transfer are usually the limiting factors.
Fed-batch has long dominated the bioprocessing industry. In contrast to the conventional batch technique, the fed-batch method adds nutrients gradually to maximize cell growth. To assist initial cell growth, a basic volume of medium is added to the bioreactor. When necessary, the feed material is supplied to replenish nutrients lost due to the growing cell population. The bioreactor still contains the cells and their byproducts after the conclusion of the run. With this configuration, the addition of feed media can be automatically controlled in accordance with nutritional levels or viable cell density.
- Continuous Fermentation
Continuous fermentation involves the continuous feeding of one or more feed streams containing nutrients and the continuous removal of the effluent stream, which contains the cells, products, and residuals. By maintaining the same volumetric flow rate for the feed and effluent streams, a steady state is maintained. The space-time yield of the bioreactor can be increased much further in a continuous process as opposed to a fed-batch operation. However, the prolonged incubation period also raises the possibility of contamination and permanent culture alterations.
Advantages and Benefits of Single-Use Bioprocessing.
Below are some of the key advantages of single-use bioprocessing.
- The cost of complex processes like sterilization, cleaning, and maintenance of steel-based bioreactor systems and accessories is decreased thanks to the disposable equipment.
- The direct cost savings in terms of low labor and material costs are one of the main benefits of single-use technology in pilot and full-scale manufacturing.
- When compared to equivalent stainless steel hardware systems, single-use systems (SUS) have lower direct labor costs during assembly as well as lower water and chemical costs.
- Due to cost savings, the usage of single-use bioprocessing equipment improves manufacturing processes' productivity.
- Increase automation complexity and do away with the necessity for changeover cleaning/validation in between activities.
- Single-use systems are thrown of after use, do not need the same level of sanitization, and the material required to make them is easily disposed of or burned.
- The usage of water and energy is actually reduced by switching from conventional equipment to a single-use system.
- For a quicker setup and less need for space, a single-use solution should be ergonomically built to accommodate integrated single-use flow channels.
Challenges in Bioprocessing
One of the biggest issues facing the (bio)pharmaceutical industry, manufacturers, and suppliers of single-use technologies is the lack of a standardized method for verifying single-use systems. The following challenges faces by pharmaceutical businesses actually exist
- The absence of a repeatable production procedure
- The impossibility of evaluating the quality and accuracy
- Inefficiency brought on by a lack of instruction regarding the use of the various single-use components
- Inconsistent practices across several production sites.
- Flexibility limitations during implementation due to poor interoperability. Not every single-use component can be merged due to a lack of standards.
- Current challenges include technological advancements and industry uptake of innovations, modeling of bioprocesses, seamless downscaling of processes, and other elements expected and even required by regulatory agencies.
How Single-Use Systems are Used in Bioprocessing
Single-use systems (SUS) are pieces of biopharmaceutical manufacturing (bioprocessing) equipment that are meant to be used just once (or for a single manufacturing campaign) and then thrown away. The majority of SUS equipment is often made of plastic parts that have been gamma irradiated, sealed, and sterilized.
The main advantages of SUS over traditional stainless steel (or less frequently used glass in bioprocessing) are that the equipment comes sterilized, allowing avoidance of cleaning, sterilization, and validation of sterilization prior to use; and avoidance of related complex steam, WFI, and other plumbing installed throughout bioprocessing facilities with large fixed stainless steel components. As opposed to reusable stainless steel equipment, which requires weeks of cleaning, sterilization, and validation, SUS equipment is effectively plug-and-play, allowing for significantly speedier process turnaround and setup of new processing lines.
What are Single-use Systems or Bioprocessing Equipment
Bioprocess equipment contains all key processing systems and tools for a particular bioprocess. Test tubes, incubators, spectrophotometers, and other equipment are used to create and run an entire bioprocess setup.
The predominant paradigm for pre-commercial (preclinical and clinical supply) manufacturing of biopharmaceutical goods is single-use systems (SUS)-bioprocessing machinery made for one-time use or a single product manufacturing campaign (1). Approximately 85% of pre-commercial upstream bioprocessing presently uses single-use equipment exclusively or mostly for manufacture. SUS is currently only being used in small-scale, commercial manufacturing.
What are Key Considerations for Validating Single-Use Systems?
Pharmaceutical businesses' perspectives on their validation process are shifting as a result of the use of single-use production methods. This is due to the fact that the convoluted supply chain for the many parts of single-use systems is not usually simplified. When employing comparable stainless steel production systems, we are used to a certain set of validation issues that suppliers and end users of single-use systems must overcome.
Additionally, pharmaceutical firms have tougher processes in place to lessen hazards associated with the development and manufacturing of drugs. How can a (bio)pharmaceutical company manage all of these variables? the solution is by delegating validation responsibilities to the other supply chain nodes.