How Single-use Technology is Transforming Pharma Manufacturing

Pharmaceutical businesses are incorporating single-use technology (SUT) into their manufacturing procedures today. As more members of the industry become aware of the fantastic benefits of this technology, this change is continuing. High-level processes can be facilitated at a wider scale by SUT-powered bioreactors. Additionally, the technique enables the production of more dependable goods, doing away with the need to sterilise containers. Pharmaceutical businesses that already use SUT report quicker turnaround times, streamlined operations, and decreased maintenance processes. Setting up equipment that runs on SUT is simple, taking only a few hours as opposed to several days for stainless installations. In addition, sterilisation validations, annual cleaning, and minimal monitoring are not required, making system maintenance reasonably simple. Single-use procedures lessen the possibility of product cross-contamination, making it simple to keep a manufacturing area sterile. Despite being a relatively new technology, SUT has several advantages that pharmaceutical firms cannot ignore. In this article we have combined four promising trends in SUT that is expected to have a lasting impact on the pharmaceutical industry.

Single-use Fermentors In the manufacturing of pharmaceuticals, single-use technologies provide a number of advantages, such as decreased time and expense, increased productivity, and simple disposal. Polymer bags are used as single-use fermentors in place of the conventional steel containers. For each test, these bags may be modified, and they are designed for high oxygen mass transfer. A proprietary fermentor technology is being developed by US-based firm New Horizon Biotech for adaptable and economical biopharmaceutical manufacturing. Single-use horizontal fermentors, also known as SUHFs, are pressurised, low volume, modular, and scalable fermentors. It has agitation impellers, aerators, and a bag retention vessel. Additionally transportable, the fermentor has a production capacity that may range from 50 to 300 litres.

Conventional Single-Use Assembling Since typical bioreactors need to be cleaned and sterilised after each run, the turnaround time between batches is long. By providing sterile, ready-to-use equipment, single-use assembly streamlines the procedure and enables biopharma entrepreneurs to create products more quickly. Additionally, by doing away with the need for cleaning and sterilisation, it saves money on chemicals. Single-use assembly and other bioprocessing technologies are provided by the Indian firm OmniBRx. The start-up offers disposable bioreactors that may be operated in a matter of minutes by one person. Due to the increased operational flexibility, time to market is shortened, and profit margins are raised.

Bioprocess Development for low-volume manufacturing Low-volume production also uses bioreactors and fermentors for one-time usage. This involves the creation of small quantities of customised medications or the pilot testing of biopharmaceuticals. Single-use technologies provide a quick fix for bioprocess development in autologous cell therapy, which uses a patient's own cells to cure ailments. French producer and contract development of gene treatments is called Yposkesi. It carries out process analysis and optimization in bioreactors with 2 to 10 litre capacity. The start-up employs a single-use bioreactor for scale-up studies up to 200 litres. Adeno-associated virus (AAV) and lentiviral therapy manufacturing is accelerated by the startup's platforms.

Advance Fill & Finish Pharma entrepreneurs leverage single-use technology in production as well as other processes where sterility is crucial. This includes the lengthy aseptic fill and finish processes that are necessary to guarantee total product sterility. The fill and finish process is automated by single-use equipment to speed up the process and lessen the unpredictability brought on by manual processing. CMAB BioPharma, a Chinese start-up, offers filling and lyophilization solutions in addition to process development and good manufacturing practise (GMP) manufacturing services. It designs the contact surfaces of the filling apparatus to be single-use only. To further reduce exposure, the filling procedure is carried out in an open restricted access barrier system (oRABS).

Future with SUT The importance of single-use technology in the manufacture of biopharmaceuticals has grown significantly worldwide. SUT's lack of uniformity and comparability with conventional systems—a flaw that impacts all process levels and the single-use systems required for them—is a significant drawback. It is thus because there isn't a design and usage advice for single-use facilities or systems. Additionally, there are no regulatory standards for single-use systems across the whole biotechnology process, nor has the industry seen any testing to evaluate the integrity of single-use systems before adoption. Additionally, there are no validated analytical techniques with leachables and extractables acceptance criteria. Therefore, it is projected that SUT will soon be employed in industries other than biopharmaceuticals (such as food, cosmetics, and algae) and animal cell culture, such as microbes, plant cell and tissue cultures, and cosmetics.