< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net FUJIFILM Corporation – Atara Biotherapeutics T-Cell facility FUJIFILM Corporation has offered $100 million to acquire a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. Located in Thousand Oaks, California, the facility is readily expandable with the flexibility to produce both clinical and commercial cell therapies including allogeneic T-cell and CAR T immunotherapies and will help expand FUJIFILM’s advanced therapies CDMO. UCB – Zogenix Another large deal, this one numbering $1.9 billion, will see Belgium-based UCB acquire rare disease drugmaker Zogenix. Famed for their treatments for epilepsy, UCB believe that Zogenix will make for a rare strategic fit and help them better treat more unique and unusual forms of epilepsy. Castle Creek Biosciences – Novavita Thera In an undisclosed agreement, Castle Creek have acquired Novavita, a preclinical gene therapy company focused on metabolic and rare liver diseases. The acquisition expands Castle Creek’s technology platform by adding in vivo capabilities to its existing ex vivo approach and will help them delve deeper into rare liver diseases and means of treating them. Takeda – Adaptate Biotherapeutics Another acquisition for an undisclosed 08-11.qxp_Layout 1 14/02/2022 08:47 Page 3Pharma Business International 11 www.pbiforum.net M&A ROUND-UP © st ock. adobe .com/Mur rst ock amount, Takeda have added Adaptate’s novel antibody-based delta T-cell engager platform to Takeda’s already well-known and respected immune- oncology range. In addition, Takeda will also be acquiring Adaptate’s preclinical candidate and discovery pipeline programs. Kriya Therapeutics – Warden Bio Kriya Therapeutics has acquired Warden Bio, a start-up with strong ties to Duke University, in a deal with an undisclosed value. Warden Bio co- founder Kunal Kishnani, an Elon University alumnus, will become the president of Kriya’s newly formed rare disease division as well as lead overall strategic, development, and partnership activities. Warden’s work has been geared toward rare disorders and is a clear sign that Kriya Therapeutics wishes to add such to their portfolio. Merck KGaA – Exelead Germany’s Merck has strengthened its mRNA business with a deal worth $780 million to acquire Exelead, a contract development manufacturing organisation, that specialises in injectable formulations. Univercells – SynHelix A final undisclosed-value acquisition in the early stages of 2022, Univercells has acquired SynHelix, a DNA synthesis biotechnology company, in a move that will see Univercells break into the synthetic biology field. 08-11.qxp_Layout 1 14/02/2022 08:47 Page 4PUMPS AND FLUIDS 12 Pharma Business International www.pbiforum.net The single-use revolution The single-use revolution 12-15.qxp_Layout 1 14/02/2022 08:48 Page 1Pharma Business International 13 www.pbiforum.net PUMPS AND FLUIDS Pumps are one of the main components of any pharmaceutical manufacturing plant, they allow products to be moved around, mixed, and dispensed efficiently and safely. But because of their importance, the right pump is essential to ensure the best, safest and fastest results. Pharmaceutical manufacturing companies have two priorities: maintain good manufacturing standards and improving time to market, and because of the nature of their role, pumps need to be safe, sterile and able to maintain high hygienic conditions throughout the whole processing line, while still being able to handle high temperature and corrosive materials and procedures and ensure good manufacturing times and performances. In order to do so, companies have to select the right equipment, and right materials that will allow them to produce drugs and medicine safely, avoiding contaminations and at a reasonable speed. While for a very long time pharmaceutical manufacturing companies have been prioritising the use of stainless steel for the equipment used in the plants, including pumps, now single-use equipment has been introduced and companies are evaluating the costs and benefits of using one or the other. Stainless steel pumps have been the go-to for a very long time. Stainless steel is reliable, durable, able to endure high temperatures and corrosive chemical reactions, and highly hygienic. However, it is arguable that clean in place and steam in place practices are lengthy and, in a way, damaging for the pump. Even if steel is resistant to aggressive cleaning procedures, in the long term, sterilisation can have an impact on the material, and on the plant and have consequences on the performance of the pump. Single-use pumps are just now starting to reach the pharmaceutical industry with a series of benefits that intrigue manufacturing companies. Single-use equipment, and pumps in particular, have been proved to improve productivity, capacity and flexibility, which are all important elements in a time when most if not all manufacturing companies are shifting to automated production plants. Single-use pumps chambers, made mostly of polypropylene, require less to no cleaning, as they are substitute in between the production of different products, which results in a reduction of downtime and maintenance times and costs. They are easier to set up, so there will also be a reduction of facility set up costs and implementation timeline. Additionally, with stainless steel pumps there is always a risk of cross contamination in between batch productions and processing of different products if they are not cleaned and sterilised properly, while single-use pumps can easily be discarded and replaced to ensure good hygiene conditions. Because they are so easy to maintain and replace, single-use pumps will provide lower long-term maintenance, upkeep and downtime costs and improve facility flexibility, as a company can easily replace a pump chamber with another depending on the requirements of the material used. One of the main issues that comes with the selection of a pump is the need to find a flexible and yet reliable piece of equipment. When it comes to pumps, it rarely is a one-fit-all solution, as every material has its own characteristics and needs, and one type of pump cannot accommodate the requirements of all. Single-use pumps chambers can Is single-use equipment really the key to a better, more efficient and safer pharmaceutical manufacturing industry? Is it time to swap stainless steel pumps for single-use polypropylene ones to ensure better results? It might be. 14 Á © st ock. adobe .com/ xmagics 12-15.qxp_Layout 1 14/02/2022 08:48 Page 2PUMPS AND FLUIDS 14 Pharma Business International www.pbiforum.net facilitate that need for flexibility, and provide companies with different types of features that will accommodate the requirements of the different types of products. Flexibility and reduced maintenance costs, resulting in increased productivity and operational efficiency, are the two main benefits of single-use pump chambers. Other influential benefits of using single-use pumps is the high batch success rate and the elimination of potential cross- contamination. By only using the pump chamber once, companies are able to virtually eliminate entirely the risk of cross contamination between one batch and the other, or one product and the other. And because pump chambers are used and discarded in between batches and products and there is no need for clean in place or steam in place practices, it is not just downtime that is reduced, but also there is a significant reduction of waste. Less water is consumed, and corrosive and toxic chemical cleaning procedures are eliminated, resulting in single-use equipment having a smaller footprint. While the continuous discarding of equipment might seem like a waste of resources and material and hence an unethical and polluting practice, single-use equipment is actually more sustainable as they eliminate the need for highly chemical and polluting cleaning products and practices. There are a few disadvantages that come with adopting single-use pump chambers; there is always a chance of breakage and therefore of loss of product. Despite the reduced chance of cross-contamination being one of the main benefits of single-use pumps, in the chance of leakage, material could reach the manufacturing stream and compromise the integrity and safety of the products and machineries, resulting in higher maintenance and cleaning costs and loss of material and profits. Due to the novelty of the materials and practices and the lack of competition between manufacturers, single-use pump chambers are still not necessarily adaptable to all types of fluids and requirements, and the costs of their disposable replacement are still significantly high. Overall, whether stainless steel or single-use pump chambers are better and more efficient is still to be decided. Manufacturing companies are evaluating the pros and cons of both equipment types and at the moment they are using a as needed approach, optimally mixing the two practices in order to increase safety, cost effectiveness and operational efficiency and aiming to increase speed of clinical trials and obtain faster and less capital-intensive paths to drug production. The market of single-use pump chambers is still growing and, despite their potential, single-use pump chambers are in need of further developing. However, the introduction of single-use materials in the pharmaceutical manufacturing industry and of single-use pumps specifically, has been revolutionary as it allows to speed production times and increase productivity while ensuring great safety standards. 12-15.qxp_Layout 1 14/02/2022 08:48 Page 3Pharma Business International 15 www.pbiforum.net PUMPS AND FLUIDS © st ock. adobe .com/ neznamo v1984 12-15.qxp_Layout 1 14/02/2022 08:48 Page 4MICROBIOLOGY AND R&D 16 Pharma Business International www.pbiforum.net sterility Testing for 16-19.qxp_Layout 1 14/02/2022 08:49 Page 1Pharma Business International 17 www.pbiforum.net MICROBIOLOGY AND R&D Testing is at the core of pharmaceutical and it is a fundamental element of any process within the industry; from research and development, to manufacturing, pharmaceutical companies carry out all kind of tests to make sure their products are safe, effective and ready to reach the shelves. There is a wide range of tests that need to be carried out and performed throughout the supply chain that involves both the products and the environment within the manufacturing plants. Testing products and environment in pharmaceutical is the most important step throughout the entire supply and production chain due to the delicate nature of the products and it is a pharmaceutical company’s responsibility to make sure their products are safe for consumers to use and will cause no harm. In order to make sure products and environments are safe, it is fundamental to make sure everything is sterile within the supply chain. Sterility is an essential condition in pharmaceutical that needs to be preserved to make sure medicinal drugs and products are safe to use; companies need to make sure both products and environments and machinery are sterile and there is no The key objective for the pharmaceutical industry is making sure products are safe for human consumption and sterility is the main condition companies need to prioritise. Sterility testing in pharmaceutical is a market that has been flourishing and that is meant to grow even further because of its importance. 18 Á © st ock. adobe .com/Dmitriy K uzmiche v © st ock. adobe .com/K admy 16-19.qxp_Layout 1 14/02/2022 08:49 Page 2MICROBIOLOGY AND R&D 18 Pharma Business International www.pbiforum.net presence of extraneous viable contaminating microorganisms in products that are meant for human use. There are three ways of testing for sterility, membrane filtration, direct inoculation and product flush, and because the different methods are used in determined circumstances and on determined products or surfaces, it’s essential to select the appropriate one depending on the specific need. Because sterility testing applies to environments and devices used during production, research and development, as well as products, different methods will be more or less appropriate to use on devices or products. Membrane filtration methods are used for pharmaceutical products that contain preservatives and that are bacteriostatic and fungistatic, and hence prevent the growth of bacteria and fungi. With the membrane filtration method the concept is that the microorganisms will collect onto the surface of a sub-micron pore size filter. This filter is segmented and transferred to appropriate media. Direct filtration methods are more appropriate to use for medical devices that are in direct contact with test media during incubation periods. Viable microorganisms that may remain in or on a product after sterilization have an ideal environment within which to grow and proliferate. This is especially true with damaged microorganisms where the damage is due to a sub-lethal sterilization process. Product flush testing methods are reserved for products that have hollow tubes such as transfusion and infusion assemblies where immersion is impractical and where the fluid pathway is labelled as sterile. Test results are usually analysed for suitability and validated in order to decide whether the development of a drug can move further. It is of great importance this type of testing is carried out in the most reliable and secure way due to the delicate nature of pharmaceutical products and equipment. Maintaining good research and development first, and manufacturing standard is a priority for pharmaceutical companies; they need to make sure the products that reach people are not just effective, but also safe to use and will cause consumers no harm. The presence of microorganisms © st ock. adobe .com/K admy 16-19.qxp_Layout 1 14/02/2022 08:49 Page 3Pharma Business International 19 www.pbiforum.net MICROBIOLOGY AND R&D like bacteria or fungi on products or surfaces during the supply chain, could compromise the integrity of the product, alter its efficacy and have consequences, in the best cases, on the sales and profits and, in the worst cases, it can affect people’s health. The importance of sterility is not limited only to the research and development phase, or the manufacturing processes, sterility needs to be reached and maintained throughout the whole process, to ensure stable and constant levels of results. The lack of sterility could potentially compromise the integrity of the products and of the company itself, and despite if it might be difficult if not impossible to maintain complete sterility, it should always be a priority to follow guidelines to make sure the environment and machineries are sterile and, hence, the products are too. There usually is a less than one in a million chance a product or an environment are contaminated with a replicating microorganism, and this is usually related to either new products or new changes or implementations in experimental conditions. However, in the chance of contamination, further testing needs to be carried out in order to achieve sterility and restore the regular functioning of the company. Pharmaceutical sterility testing was valued 833.1 million USD in 2020 and it is predicted to value over 1351.7 million USD by 2027. There are several external businesses that today offer sterility testing to pharmaceutical manufacturing companies and specialise in the different methods to offer companies greater services and results. Lately, many companies are switching to single-use equipment to ensure good levels of sterility and reduce costs of cleaning and sterility practices; the switch is, in the long run, meant to increase efficiency and improve productivity while maintaining good manufacturing standards. Sterility is a core condition in the pharmaceutical industry and it is fundamental to ensure products and environments are safe. Testing for sterility is a routine practice, but it is also fundamental for companies who want to maintain good manufacturing standards and provide consumers with the best quality, and therefore needs to be carried out in the best and most reliable way. © st ock. adobe .com/ dipr oduc tion 16-19.qxp_Layout 1 14/02/2022 08:49 Page 4Next >