Enabling industry 4.0: field-deployable real-time measurements and data sciences.

Expert Services

Data Sciences

Multivariate analysis, machine learning, and chemometric model development, validation and implementation. Particular expertise in data analysis of large spectral datasets (Raman, IR/NIR, LIBS, etc.) to include the compilation of complicated datasets and associated metadata.

Process Control

Expert QbD and lean sigma consultation for multifaceted process variation understanding and development of process control strategies across process streams for biopharmaceutical, chemical, and food & beverage.

Analyzers & Sensors

Facilitate selection of commercially viable for real-time monitoring sensors and analyzers to enable feedback-feedforward control and continuous process verification across biopharmaceutical and chemical manufacturing unit operation. Selection and optimization of sensors and analyzers also includes field applications such as environmental, geological, and unmanned ground vehicles (UGV). Design and commercialization of novel real-time measurement systems. Design of fit for purpose unit operation mechanical/IT integration approaches.

Material scienceS

Material assessment, selection, and specification (e.g., CoA). Security of supply or material supply redundancy and just-in-time real-time quality release.

Analytical Automation

Multifaceted autonomous measurement system design, development, and commercialization to include sampling, data management, traceability, analysis, and reporting.

Software Engineering

Development of industrialized GUI or augmented capabilities for data acquisition, enhanced data analysis, fit for purpose automated performance verification, and integration with other supporting systems
(e.g., Historians, SCADA, PLC etc.).

Chem-Bio Threat Assessment

Facility and personnel chemical and biological threat assessment, mitigation approaches, and consequence management services.

Industries Served

  • Upstream, downstream purification, and formulation process development and commercialization along with process monitoring and automated controls underpinned by QbD and lean sigma principle.  Support recombinant proteins, mRNA-LNP, and conjugated biomolecules.

  • Upstream production, downstream purification, and formulation process development and commercialization along with process monitoring and automated controls underpinned by QbD and lean sigma principle.  Support Inhaled, solid oral dose, injectable and cream/onement based small molecule pharmaceuticals.

  • Development, optimization, and manufacture of fine chemicals and polymers along with process monitoring and controls and supporting laboratory quality analytics.

  • Development and optimization of robust mobile automation skids, sensors, and analyzers to support real-time environmental monitoring and mining operations.  Examples of real-time analytics developed or optimized include fluorescence sensors, Raman, and LIBS along with robust fit for purpose multivariate calibration models.

  • Facility and personnel chemical and biological threat assessment, mitigation approaches and consequence management services.

  • Personnel chemical and biological threat assessment, mitigation approaches (monitoring and PPE), and consequence management services.

Example Projects Delivered

  • Led the selection, development, and implementation of handheld Raman capability for rapid raw material identification (ID) for 100 biopharmaceutical materials that enabled on demand or just-in-time manufacturing across several production facilities.

  • Designed a state-of the art material sciences laboratory to assess biopharmaceutical raw material variation that enabled implementation of several mitigation control strategies.  The laboratory monitored numerous impurity and compositional attributes that are not assessed by conventional compliant specification modalities. The laboratory drove a significant reduction of batch failures and CAPA occurrences across both clinical and commercial assets.

  • Designed, qualified, and implemented several laboratory automation skids that expanded sample throughput and traceability to support various longitudinal cohort metabolomic studies.

  • Led the selection, development, and deployment of multiple rapid and sensitive toxic vapor phase autonomous monitoring capabilities that supported consequence management operations to ensure appropriate level of personal protective equipment (PPE) utilization.

  • Specified, fabricated, developed, and deployed a rapid autonomous infrared vapor phase multipoint  monitoring system in 3 months to support production of a fine chemical that involved toxic starting materials.  

  • Oversaw upstream production and downstream purification development of disparate immunogens (recombinant/conjugated proteins and mRNA/LNP) for HIV, coronavirus, and influenza that enabled cGMP production to support phase I clinical trials.

  • Adapted a fluorescence sensor that enabled at-line rapid and low dose monitoring of a solvatomorph in solid oral dosage forms.  The fluorescence sensor was pivotal as offline laboratory quality release and analytical methods were insufficient to mitigate solvatomorph formation.

Contact

Accelerate Nova LLC.
Durham, NC
(919) 802-8503