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Advanced Therapy Medicinal Products (ATMPs)

Addressing the Challenges of ATMP Manufacturing is Vital to Bringing Innovative Cell/Gene Therapies & Tissue Engineered Products to Market.

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 culturing, 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. Our solutions help ATMP manufacturers meet these challenges to ensure consistent quality and performance when scaling up production.

Explore Our Solutions:                  

SCADA Solutions

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 ATMPs. Furthermore, lack of standardized methodologies for testing ATMPs complicates quality assurance efforts. Our solutions… 

Solutions:  

ETL Pipelines

Electronic Batch Records

QMS Integration

Electronic Logbooks

Process Agility

Rapid deployment of manufacturing optimizations…

TBD from Josh/Team

 Solutions: 

Electronic Batch Records

Digital Twin

Data Management & Digital Infrastructure

Capturing real-time data from biomanufacturing processes is challenging, yet critical, for optimization and compliance. Our solutions are designed to help ATMPs capture, contextualize and analyze manufacturing data…..

Solutions:   

Digital Dashboards

Data Contextualization/UNS

LIMS/ERP 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 solutions facilitate… 

Solutions:

Real-time Operations Scheduling

Electronic Batch Records

Material Tracking/ Management

Artificial Intelligence & Machine Learning

AI and ML can transform 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. Additionally, AI-driven decision support and training tools enhance workforce efficiency, while personalized medicine benefits from AI-powered patient stratification and dosing models. Ultimately, AI/ML solutions help ATMP companies reduce costs, scale production, and improve treatment accessibility.

Solutions:

Data Contextualization/UNS

PAT (Process Analytics)

EDGE Computing

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