Using advanced transfer learning methods, we can quickly develop processes by understanding how they behave across different scales and products. Hybrid models are particularly useful because they combine data with process knowledge, making the development process more cost-effective as less experiments are required. We will showcase a new method for learning across different products and how it can be applied in digital twins to aAgendaccelerate process development.

In the car industry, different variants of cars were crashed to determine the safest configuration. Nowadays, the optimization for crash safety is done on the computer, and one car is crashed to validate the simulation. The same should be true for scale-ups in the biotech industry: Based on a reactor characterization in the lab scale, a computer simulation can determine the ideal process parameters for the production-scale reactor. One batch determines the validity of the simulation-based scale-up. The production is started immediately afterward. All the intermediate scale-up volumes are skipped, thereby reducing the experimental load and the time-to-market. In this presentation, you will see how close we are to this vision.

Both before and throughout the recent COVID pandemic, preparedness to ensure business continuity in the event of supply disruption has been paramount to ensure the continued availability of patient therapies and uninterrupted business operations. The BioPhorum ‘Best Practice Guide to Business Continuity Management in the Biologic Supply Chain’ is based on ongoing industry collaboration with subject matter experts and provides consensus recommendations to enhance the resilience of the biologics industry. It provides a framework based on internationally recognized standards. By systematically implementing these principles, which can be adapted to the scale and breadth of any individual company, companies can improve their business continuity management systems, supporting industry growth and meeting regulatory requirements. This presentation shares how the guide promotes a consistent approach throughout the supply chain, benefiting patients, companies, and the industry as a whole, and details how to use the associated questionnaire and evaluation tool. Companies supporting the biologics supply chain are strongly encouraged to review existing practices alongside the proposed recommendations, in order to ensure effective management of disruptions, improve communication within the supply chain, and ultimately benefit patients, companies, and the industry as a whole.

Virus inactivation is a critical operation in therapeutic protein manufacturing. Low pH buffers are a widely used strategy to ensure robust enveloped virus clearance. However, aggregation of certain protein products at low pH presents a challenge. One of the classical methods for viral inactivation (VI) is the detergent treatment step in the manufacturing of various drug modalities, including antibodies, plasma-derived products, and AAV. Additionally, detergent-based processes can be performed upstream of downstream steps, thereby increasing the viral safety of the overall process. In this presentation, we will discuss the application of a novel biodegradable detergent to enhance VI while in compliance with the regulation. An extensive study with different model viruses demonstrated its capability of providing >6.5 Log of viral inactivation and high virus-killing kinetics independent of operational temperatures (4 ⁰C to RT). Other benefits of using this detergent include no environmental toxicity, and no impact on product stability or process performance. This detergent can easily be removed from the product and detected by a simple analytical assay.

There is a widely recognized need to transform biopharmaceutical development and manufacturing to reduce costs, increase the flexibility of equipment and facilities to accommodate an extremely diverse and changing portfolio of products. This presentation will focus on recent developments in membranes as alternatives to column chromatography for product capture and purification in a wide variety of different applications including protein therapeutics, vaccines and cell and gene therapy.

Based on product development and the manufacturing experience, many examples are known where HCPs could severely impact patient safety. Therefore, the tight control of HCPs is an important issue for many product classes. The removal and control as well as the characterization of HCPs are important measures to guarantee high quality and safe biomedicines. This primary goal is supported by EU and US guidelines providing effective tools to circumvent hurdles during the licensing process. State-of-the-art control strategies during product development and throughout the product life cycle are required to be implemented. An HCP risk assessment should complement the studies. In this presentation, the understanding of the regulatory decisions will be facilitated by case studies.

Significant effort has been made to launch the novel Planova filter—Planova S20N—using superior regenerated cellulose with improved pressure resistance to meet challenges in the production of biopharmaceuticals. Planova S20N does not require the Gold Particle Test (GPT) due to resistance to high pressure, similar in its concept to Planova BioEX, making process development experiments optimal in terms of efficiency and cost. Planova S20N shows higher throughput, robust virus removal capability, and stable protein filterability at higher operating pressures while achieving stable filtration over a wide range of solution conditions, inherited from Planova 20N. The characteristics and the results of internal studies will be discussed in this presentation.

There is a huge need to produce vegan cheese, which has the same taste and stretchiness as the classical one. However it needs to reach cost parity. Fermify is developing in fully digitalized continuous production platform to achieve scalability and cost effectiveness. This contribution will identify the main ingredients…such as the unique combination of continuous biomanufacturing, digital twins and PAT paired with bioprocess technology domain knowledge.