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Digital Enablement

From the start, AmplifyBio has embraced technology's potential to transform advanced therapy development. We continuously invest in cutting-edge IT systems to streamline operations and ensure data integrity. This digital focus fuels our efficiency, minimizes compliance risks, and ultimately speeds up the delivery of groundbreaking therapies to patients.

AmplifyBio’s commitment to digitalization is rooted in its drive for excellence and dedication to delivering exceptional results. By harnessing the full potential of advanced IT systems, the company has reimagined traditional workflows, optimized processes, and fostered operational agility. This approach has improved operational efficiencies and paved the way for increased productivity, streamlined data management, and enhanced decision-making capabilities.

Operational Benefits

Internal

🗹 Faster execution turnarounds

🗹 Inherent data integrity controls

External

🗹 Prompt delivery of data reports and analyses

🗹 Compressed cycle times

A Facility Built for Advanced Therapy Manufacturing

Featuring an integrated Electronic Document Management System (eDMS), streamlining document control, collaboration, and quality processes for improved transparency, compliance, and accessibility.

A fully digital and validated equipment lifecycle management system, including automated calibration and preventative maintenance.

Our advanced EMS, equipped with smart sensors, delivers real-time laboratory insights, preemptively safeguards experiments, and ensures data integrity through continuous monitoring.

Our integrated LIMS and Electronic Lab Notebooks (ELN) equip researchers and laboratory operators with robust tools, enabling them to concentrate on scientific endeavors by facilitating effortless data capture, collaboration, sample tracking, and adherence to compliance standards.

A cutting-edge MES, thoroughly validated, featuring electronic batch records (eBRs) with expedited quality event reviews (review-by-exception). This enhances visibility, control, and traceability across the entire production process, streamlining paperless releases with built-in data integrity checks.

Our supply chain inventory management solution enables end-to-end visibility into every stage of the supply chain. It provides complete traceability of all raw materials and products flowing through our facilities. This visibility enables smart and streamlined planning, scheduling, and purchasing.

Paperless and workflow-driven Validation Lifecycle Management System (VLMS) that reduces errors, mitigates compliance and data integrity risks, and increases process velocity and throughput.

Incorporating automated pipelines for seamless data acquisition from laboratory equipment expedites our research process. Automating intricate analyses enables us to produce reports within weeks, rather than months, leading to substantial cost savings and quicker turnaround times. This empowers our scientists with streamlined data access, accelerating project timelines and mitigating risks to data integrity.

Business analytics dashboards drive our daily operations, transforming data into actionable insights for stakeholders. This empowers informed decision-making, process optimization, and innovation.

ADOC

AmplifyBio Discovery, Optimization, and Characterization

An outsourced R&D solution for benchmarking next-generation therapeutics

ASET

AmplifyBio Safety, Efficacy and Toxicology

A preclinical CRO built for the future on a decades-long foundation of expertise and experience

AMEC

AmplifyBio Manufacturing Enablement Center

A manufacturing partnership for multiple modalities, offered in flexible contract staffing models to fit varied requirements

Contact Us

Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing available in an integrated, innovation-rich environment that goes beyond the value proposition offered by traditional CDMO and PDMO contract models.