[Reducing Time and Cost for Large-scale Biopharma Plant Construction Utilizing Robust and Secure PMI Methodology]
Poster Presenter: Clemens Borkenstein
The poster will explain the current challenges in material traceability by following heat numbers and proposes the use of another technology with many advantages instead. Typically, the heat number of individual components is used as the preferred method of identification and tracking. However, this does not ensure identification security if the heat number is lost during fabrication. There is a faster, cheaper and more secure alternative - positive material identification (PMI) – technique which detects types of stainless steel, with near 100% accuracy, utilizing hand-held x-ray fluorescence (XRF) instruments. The quality of the product contact surfaces, as well as the chemical composition of the steel, is critical for avoiding corrosion for the lifetime of the process systems. XRF Systems allow for this additional monitoring.
The poster will explain the many advantages of the PMI Technology, and show a case study of a large-scale cell culture facility construction project, consisting of 6.3Km of pipes, 9,500 components and 45 vessels (ranging from 100 to 30,000L). This robust method uses XRF innovatively to analyze the chemical ingredients of the stainless steel to guarantee specification.
[Single-Use or Stainless Steel? Hybrid Systems May be the Solution the Industry is Looking For]
Poster Presenter: Lindsay Smart
Single-use assemblies are highly manufacturer specific and if these components do not comply with the individual production process of the API, they can be used only in a limited way, possibly ineffectively, and often at higher costs. Furthermore, there is a risk of contamination from extractables and leachables, which can negatively impact product quality. In contrast, customized stainless steel solutions, which do not have these disadvantages, can tend to be less flexible and require time-consuming cleaning and sterilization processes.
State-of-the-art hybrid solutions are based on well-designed engineering concepts, combining single-use technologies with high-end stainless steel components. Therefore, benefits of both system types can be realized: low investment costs, high flexibility and shorter set-up times of single-use technology are combined with durable stainless steel components, guaranteeing the highest level of process automation, safety, integrity and reproducibility. This presentation will detail how current isolated and stand-alone assemblies can be customized and interconnected with highly sophisticated cross-functionality – from a mechanical and automation perspective – for generic bio-manufacturing plants. This involves customized technical adjustments and optimization of single-use equipment, from replacing single components, such as heating-cooling circuits, gassing stations and automation systems, to complete retrofitting of stainless steel components to the single-use facility.
[Quantitative ß-Globin Expression using RP-UPLC]
Poster Presenter: Agnes Lin
ß-hemoglobinopathies are genetic diseases that affect many patients worldwide. Transfusion-dependent ß-thalassemia (TDT) and severe sickle cell disease (SCD) result from mutations in the ß-globin gene impairing production of functional hemoglobin A (HbA). Gene therapy has the potential to alleviate complications from TDT and SCD by reconstitution of functional red blood cells. LentiGlobin gene therapy contains autologous CD34+ cells transduced ex vivo with the BB305 lentiviral vector (LVV) encoding ß-globin with a T87Q substitution, ßA-T87Q-globin. Following myeloablation and LentiGlobin infusion, transduced HSCs engraft in the bone marrow and differentiate into progenitors that express ßA-T87Q-globin.
A quantitative assay for ßA-T87Q-globin protein is needed to monitor expression of gene therapy-derived Hb. Therefore, the T87Q amino acid substitution needs to be distinguished from wild type ß-globin. We developed an optimized reverse-phase ultrahigh-performance liquid chromatography (RP-UPLC) method to show clear separation of the ßA-T87Q-, ßA- and ßS (sickle)-globin chains. The method has followed ICH Q2 R1 guidelines and will be an important tool to ensure the accurate quantitation of the therapeutic protein expression.
[Vacuum Wastewater Conveyance In Pharmaceutical Applications]
Poster Presenters: Brian Smith & Dan Lonergan
Vacuum wastewater systems are a proven technology and Airvac has been installing them since the early 1970s in the USA. Not
widely known as an alternative to gravity systems, the technology is especially useful in situations involving older infrastructure
where existing plumbing lines may be inaccessible or too disruptive to hook into in an operating facility. In addition, the Airvac system
can literally be installed anywhere with less project labor and business disruption. Airvac is the only known company that has
successfully installed these negative pressure systems in FDA regulated facilities in both the US and Europe. Our system is modern,
internationally available and can transform a facility into a modern structure. In Switzerland, Airvac is commissioning a brand new
modern 10 story building for Roche that will be entirely negative pressure for all the wastewater generated at the site including all
black, gray, autoclave and lab waters. 270 vacuum floor drains are installed that make the facility totally modular where renovations
involving plumbing are totally non disruptive and simple.
[Comparative Assessment of Multi-use Component (Diaphragm Valves and Hygienic Gaskets) Service Life
Poster Presenter: James D. Vogel
Unlike stainless steel and single-use components which have been thoroughly defined and qualified, there has been little attention given to these overlooked components that literally hold your process together. The studies focus on true side-by-side comparisons without the application variabilities by studying different component materials, manufacturers, sizes, and configurations in controlled test conditions – giving hygienic gaskets and diaphragm valves the attention that they have deserved to help you make a more efficient process.
[A Risk-Based Approach to Stainless Steel Equipment Maintenance]
Poster Presenter: Elizabeth Rivera
Considering the risk associated with rouged surfaces, manufacturers would benefit from focusing more attention on treatments that prevent rouge from happening. Some companies take a reactive approach and wait until rouge has been detected or has impacted production before taking corrective action. Process attributes such as elevated temperature, extreme pH solutions, or surface damage (e.g., from poor quality welding) can corrode stainless-steel surfaces (4-7). If a process or surface condition is expected to lead to corrosion at some point during the life of the equipment, then an effort should be made to investigate and prevent that corrosion from occurring.
[Viral Safety of Cleaned Surfaces Using a Risk-Based Approach]
Poster Presenter: Paul Lopolito
Viral cross-contamination of process equipment and small parts is a concern for biopharmaceutical and medical device industries. Viral contamination can lead to costly delays in production, product loss, and regulatory issues. Viral clearance studies focus on viral inactivation or removal steps within the process flow ensuring a theoretical viral log reduction and low viral risk. The viral clearance strategy often overlooks the potential of cross-contamination from equipment surfaces and small parts from one donor, batch or product to another. An effective clean-in-place (CIP), automated part