Advanced Therapy Medicinal Products (ATMPs)—such as gene therapies, somatic cell therapies, and tissue-engineered products—involve living cells, patient-specific processes, and highly sensitive biological components, making production both intricate and costly. Scaling up from small-batch, personalized treatments to commercial manufacturing, while ensuring consistency, safety, and regulatory compliance, adds further complexity. Addressing these manufacturing challenges is crucial for making ATMPs more accessible, cost-effective, and scalable to meet growing patient demand.
Key Challenges for Advanced Therapy Manufacturing
Apperture understands the unique challenges of ATMP manufacturers—regardless of product lifecycle. From establishing a technology infrastructure and information security, through the management of equipment, documents, and materials, to facilitating the use of data for analytics and visualization, we have the expertise and knowledge to support a variety of solutions to meet your needs.
Click to explore our solutions to these challenges.
Automation & Scalability
Developing Advanced Therapies involves labor-intensive processes, such as cell culture, genetic modification, and tissue engineering—all which are difficult to scale efficiently. Many manufacturing steps are still manual and not automated, increasing variability and production time. By utilizing automation to support production scale-up, our solutions help ATMP manufacturers meet these challenges to ensure consistent quality and performance.
Explore Our Solutions:
▶ SCADA |
▶ Electronic Batch Records |
▶ Electronic Logbooks |
|---|
Data Integrity & Compliance
Advanced Therapies are often derived from living cells, which introduce variability that is hard to control. Current quality control methods may not be sensitive or robust enough to detect subtle variations in ATMP products. Lack of standardized methodologies for testing further complicates quality assurance efforts. Our solutions ensure the process is accurate, consistent, and reliable—facilitating data integrity and regulatory compliance throughout the product development and production lifecycle.
Solutions:
▶ ETL Pipelines |
▶ Electronic Batch Records |
|
|---|---|---|
▶ QMS Integration |
▶ Electronic Logbooks |
|
Process Agility
The ATMP market is consistently striving for agility and flexibility to quickly adapt, respond, and pivot during the research, development, and production phases of Life Sciences products, all while maintaining compliance, quality, and safety standards. Our consultants can help ATMP clients navigate improvements in process agility—reducing delays and improving development timelines in a competitive market.
Solutions:
▶ Electronic Batch Records |
||
|---|---|---|
▶ Digital Twin |
||
Data Management & Digital Infrastructure
Capturing real-time data from Life Sciences processes is challenging, yet critical, for optimization and compliance. Our solutions are designed to help ATMP clients capture, contextualize and analyze manufacturing data to ensure product quality, regulatory compliance, and operational efficiency. By leveraging advanced digital technologies—such as cloud computing, AI, data analytics, and real-time data monitoring—ATMP clients can enhance decision-making. As the industry continues to evolve, these systems will become increasingly more sophisticated, helping to bring innovative treatments to patients more quickly and safely.
Solutions:
▶ Digital Dashboards |
▶ Data Contextualization/UNS |
▶ ERP/LIMS Integration |
|---|---|---|
▶ Data Warehousing |
▶ Edge Computing |
▶ Data Analytics |
▶ ETL Data Pipeline |
||
Supply Chain Logistics
Chain of Identity and Custody are key to successful commercialization of Advanced Therapies. Ensuring accurate tracking of patient specific ATMPs (e.g., autologous cell therapies) throughout production and delivery requires sophisticated digital solutions like blockchain or RFID. Our consultants can help tailor a solution that will provide operations and maintenance scheduling in real time, while facilitating electronic work processes to drive compliance and enable real time release, streamlining the drug product supply chain.
Solutions:
▶ Real-time Operations Scheduling |
▶ Electronic Batch Records |
▶ Material Tracking/ Management |
|---|
Artificial Intelligence & Machine Learning
AI and ML are transforming ATMP manufacturing by optimizing processes, enhancing quality control, and improving supply chain efficiency. Predictive modeling and digital twins refine bioprocess conditions, while AI-driven automation reduces manual intervention and batch failures. Machine learning enables real-time monitoring, predictive quality assessments, and faster batch release, ensuring consistency and regulatory compliance. Our solutions incorporate a variety of AI and ML functions to help ATMP manufacturers reduce costs, scale production, and improve treatment accessibility.
Solutions:
▶ Data Contextualization/UNS |
▶ PAT (Process Analytics) |
|
|---|---|---|
▶ Edge Computing |
▶ Digital Twin |
|