1. Planning for Liquid and Lyo Formulations in Parallel & A Risk Management Approach to Lyo Cycle Robustness Study Design by Kevin Ward

Planning for Liquid and Lyo Formulations in Parallel:

The primary use of lyophilization is to stabilize products that do not exhibit sufficient shelf stability in the liquid state. However, this is not always limited to the final product itself. For example, it may be employed strategically to provide material for pre-clinical and early clinical studies for an investigative medicinal product, while work continues in parallel on the longer term goal of developing a stable liquid formulation. This presentation will explore the reasons, concepts and practicalities of developing liquids and lyo formats in parallel.

A Risk Management Approach to Lyo Cycle Robustness Study Design:

Historically, the demonstration of robustness for a lyo cycle was never demanded as part of the drug filing paperwork for a (bio)pharmaceutical product. However, it is now expected that some robustness of the process is evidenced as part of the supporting documentation, although there is no harmonized guidance on how this might be approached. This presentation will explore and contrast two classical approaches – the iterative approach and the ‘Quality by Design’ (QbD) approach – and will introduce a ‘hybrid’ approach that incorporates a formal risk management element into the iterative approach, which may represent a workable solution with enhanced data output.

2. The use of AI and Machine Learning Algorithms in Lyophilisation & The Power of DoE for Formulation Design by Sam Woodyard

The use of AI and Machine Learning Algorithms in Lyophilisation:

Current AI and Machine Learning models such as ChatGPT, Co-pilot and DeepSeek are revolutionising how we approach problem solving, not just in the pharmaceutical, biotech and diagnostic industries, but across every sector in the world. In lyophilization, there is a clear benefit to their use in formulation design and cycle development. However, as advantageous as these systems are, there are definitive shortcomings that can lead to inaccuracies in cycle design and even batch failure. In this presentation, we will explore the contrast between these off-the-shelf systems and how Biopharma Group is leveraging 25 years of expertise and real-life datasets to design a customized Machine Learning platform specifically targeted towards the development of lyophilized products.

The power of Design of Experiments for Formulation Design:

Formulation design in lyophilization is a key factor in producing a stable product with a long shelf-life and good activity in the liquid state post-reconstitution. The traditional one-factor-at-a-time approach to formulation design can deliver a workable formulation, but may not yield the most optimum design.  Design of Experiments (DoE) software applies statistical/factorial experimental methods to calculate the quickest and most effective route to identifying the optimum formulation for a lyophilized product by enabling the identification of critical factors, interactions, and optimal conditions that drive product stability and performance. This presentation will explore the benefits of the typical DoE approach and what is required to identify the ‘optimum freeze-drying formulation. 

3. Continuous and Controlled Freeze Drying According GMP by Jos Corver

After showing the background of the RheaVita technology, we are going to present results from the GMP-ready prototype including process data. This will demonstrate the power of process control at the individual vial level. Next we will give an outlook towards the embedding of the technology into an industrial manufacturing environment, including the integration with grade A environment pre and post freeze drying.

4. Process Analytical Technology and Metrology: Developments in TDLAS for Process Development and Control by Emily Gong

This work presents the development of a Process Analytical Technology (PAT) enabled freeze-dryer that automatically designs and controls lyophilization cycles using real-time sensor data and predictive modeling. The system integrates tools such as Tunable Diode Laser Absorption Spectroscopy (TDLAS), manometric temperature measurement, thermocouples, and pressure gauges to continuously adjust drying conditions based on the warmest vial temperature, addressing both intra- and inter-batch variability. Tested with sucrose and proprietary drug formulations at both lab and pilot scale, the algorithm successfully maintained product temperatures below critical limits with minimal safety margins, adapted to anomalies like pressure loss and vial overfilling, and automatically determined drying endpoints. Scale-up was achieved by incorporating vial heat transfer data and resistance models, enabling accurate prediction and control of product temperature throughout the process. This approach supports rapid process development, robust control, and efficient scale-up in freeze-drying of biopharmaceuticals.

5. Validation Experience with Lyophilization by David Fencil

In developing a new product or a modified product, one must convince themselves and the regulatory bodies that the processes used to produce said product consistently and reproducibly yield product that conform to specifications. This session will discuss experience with validating mixing and freeze-drying of this product. This enzyme product is used as one step in disaggregating skin cells from a small skin sample for reapplication to a prepared burn wound, and must be reliable every time. To ensure this, the mixing, filling, and lyophilization processes were validated. We will briefly discuss the basics of validation (IQ, OQ, PQ) then take a deeper dive into how we approached this process. After this session the participants should know how to approach validation of lyophilization, how this was performed in one case, and begin thinking toward how they might do the same, as necessary.

6. Automated Visual Inspection Solutions for High Potency Drugs and Antibody-Drug Conjugates (ADCs)
by Dan Cremer

The growing adoption of highly potent drugs and antibody-drug conjugates (ADCs) presents unique challenges for pharmaceutical manufacturing, particularly in inspection and quality assurance. ADCs are designed with powerful cytotoxic payloads, making operator safety and containment critical considerations. Traditional manual and semi-automated inspection methods expose staff to unnecessary risk, create ergonomic burdens, and struggle to maintain consistent quality at scale.

This presentation examines evolving industry trends in ADC production, including Occupational Exposure Limit (OEL) and Occupancy Exposure Band (OEB) requirements, batch size considerations, and the limitations of legacy inspection approaches. It then introduces the ATS PharmaScan HiPo automated visual inspection platform, developed to meet the stringent demands of high-potency drug handling. Key features include robotic vial singulation, non-glass-to-glass handling to minimize breakage, automated reject segregation, and ATS SmartVision technology for high-speed, single-pass defect detection. Integrated isolator containment further reduces operator exposure while maintaining throughput and regulatory compliance.

By combining advanced automation with validated high-potency handling, the PharmaScan HiPo enables manufacturers to improve safety, efficiency, and product quality. The session highlights how automation redefines inspection for ADCs—delivering a safer, more cost-effective, and future-ready solution for high-value biopharmaceuticals.

7. Challenges in Transferring a Legacy Lyophilisation Processes to a New Manufacturing - Conforming to Regulatory Expectations by Zak Yusoff

Transferring legacy products comes with its unique challenges. This presentation will explore some aspects of transfer that should be considered prior to, during and after the transfer process to ensure a successful and compliant transfer of your product to a new manufacturing line. Consideration to processes, equipment, facility, and capability which will have some impacts to the transfer will be explored. We will discuss a few transfer scenarios and case studies to demonstrate the regulatory expectations.

8. Lyophilization of Nucleic Acid Extraction Reagents by Cristina Ivy

Lyophilization plays a critical role in Grifols’ operational and product development strategies, offering multiple advantages that enhance efficiency and reliability across workflows. This freeze-drying technique ensures room temperature stability of nucleic acid extraction reagents which is important in significantly extending shelf life and simplifying storage requirements. By streamlining preparation steps, lyophilization also reduces time to result, accelerating diagnostic and analytical processes. Furthermore, it minimizes instrument consumable waste, contributing to more sustainable laboratory practices. The flexibility it introduces into nucleic acid extraction workflows allows for greater adaptability in diverse testing environments, reinforcing Grifols’ commitment to innovation and operational excellence.

9. Humidity-Induced Collapse in Freeze Dried Cakes by Dynamic Vapor Sorption by Sean Seefeld

As the number of freeze-dried therapeutics increase, the role of water on the long-term stability, activity, structure, and drug-carrier interactions becomes increasingly critical to the successful development of biopharmaceuticals. For instance, water may have a range of effects on proteins including: hydrolysis, oxidation, deamidation, and folding. Each of these interactions affect the bioactivity and stability of the formulation. In particular to freeze-dried formulations, changes in moisture content may cause a glass transition and/or crystallization event of the formulation resulting in a loss of stability. This presentation will overview Dynamic Vapor Sorption (DVS) as a technique to study moisture sorption behavior on freeze-dried materials and provide multiple case-studies. 

Biopharma Group Speakers:

Guest Speakers: