Consulting Services

Alkemy Innovation, Inc., an engineering company with a well-developed acumen in crafting process analytical technology (PAT) and data analytics solutions for the pharmaceutical, life science and related industries. The company works with clients to identify opportunities to implement these solutions that will ultimately drive innovation and growth while reducing costs. 

Alkemy Innovation provides technical support for design, implementation, and execution of science-based solutions that provide specific technical guidance.

 

Example Services:

  • Provide an effective, business-aligned, data handling, analysis, and reporting strategy to support the business portfolio.

    • Development of an fffective data management and analytics strategy

    • Design and implementation of a Proof-of-Concept project to assess the value of a solution (hardware and/or software)

    • Engineering analysis of specific data sources for a specific project need, Including data historian options

  • Perform Process Analytical Technology (PAT) Assessments

  • Process Model Development: cell-focused, process-focused, business-focused; First principles or multi-variate approaches

Example Activites:

  • Design

    • Architecture for Data Management Strategy; Design visual layout, including plan for access/use of data.

    • Tool Selection Strategy; Review and recommend tools for data collection/management.

    • Measurement Approach;  Develop on-line/at-line measurement strategy to support predictive model development. Includes review of planned hardware purchases (e.g., new bioreactor installation).

    • Modeling Approach;  Define physical situation, inputs required, and plan for model verification/validation.


  • Implementation/Start-up

    • Data Management Architecture; Implement to enable full data access and visualization.

    • Development of Predictive Models; Utilize data scientist approach to develop models

    • Technology Assessments; Support implementation of new technologies.


  • Longer Term Execution

    • Tuning of Existing Models;  Enable further improvements in product quality and process robustness.

    • Creating “Golden Batch” Monitors; Leverage the tools implemented (e.g., add early warning detection).

    • Automation of Repetitive Tasks; Utilize existing architecture to automate key reporting.

    • Support for Tuning Installation; Automation of repeated analysis tasks and reporting for
      future reference (software focus).

On the Products front:

We have also partnered to develop the Biotech Lab Module and the Pharma Engineering Module for scientists and engineers wanting to access, analyze, and summarize non-continuous, batch- focused data to have: 

  • Effective Work Processes: Support workflows execution through analysis and reporting.   

  • Knowledge Creation and Knowledge Management: Streamline cross-group access to maximize use of existing data and share results.

  • Optimized Use of Time and Key Resources: Minimize rework or avoid unnecessary experimentation.

  • Better Science and Engineering: Ask the right questions at the right time.

Designed to support both Business & Scientific Leadership and R&D and Manufacturing Teams

Consider the Biotech Lab Module or the Pharma Engineering Module as your solutions to needing the ability to rapidly analyze and derive insight from batch data produced from online and offline process and analytical instruments. 

For more information about the Biotech Lab Module and the Pharma Engineering Module, please contact us at alkemy@alkemyinnovation.com

Resources:

  • "A Model-Based Methodology for Spray-Drying Process Development" (Link)
  • "Data Integration Methodology that Couples Novel Bioreactor Monitoring Tools; Automated Sampling and Applied Mathematics to Redefine Bioproduction Processes" (Link)
  • "Insights into Monitoring Changes in the Viable Cell Density and Cell Physiology Using Scanning, Multi-Frequency Dielectric Spectroscopy" (Link)

From Data to Direction.

Contact Info

Alkemy Innovation
alkemy@alkemyinnovation.com
541-408- 4175
Bend, OR