LIFECYCLE STAGE: DESIGN

Author, simulate, and refine your product's manufacturing process early to seamlessly scale-up

The Design Stage incorporates:

Product definition

Recipe creation

Process development digitization

Use case #1: Authoring Product Process

Use case #2: Process Development and Scale-Up

Use case #3: Product Definition

Use case #4: BioPharma Product Lifecycle Management (PLM)

Design Stage use cases

DESIGN STAGE: USE CASE #1

Authoring Product Process

Create, templatize, and parameterize procedure steps for comprehensive batch production — all without code.

Empower Recipe Authors, Master Data Managers, and Control Systems Engineers to collaboratively craft work instructions, SOPs, and drug recipes, utilizing batch parameter groups and object libraries for a high degree of scalability.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$690,981

Large molecule
$68,839

DESIGN STAGE: USE CASE #2

Process Development and Scale-Up

Iterate to find the optimal process and quickly go from from formula, to pilot, to batch.

Enable Product Development Scientists and MSAT Engineers to optimize recipes, redline batches, and compare runs for continuous improvement.

Collaborate on process development to rapidly scale from formulation to pilot to batch.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$287,045

Large molecule
$474,506

DESIGN STAGE: USE CASE #3

Product Definition

Create and manage enterprise product definitions, recipes, and master data directly from one manufacturing platform.

Create a centralized definition of products, recipes, and data that can unify operations across your network of manufacturing sites.

Design a core recipe that can then be shared, accepted, and iterated on by each site.

Foster cross-functional collaboration across teams, sites, and stages, implement data governance from a center of excellence, and analyze trends to streamline operations and automatically perform tech transfers.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$244,045

Large molecule
$404,209

DESIGN STAGE: USE CASE #4

BioPharma Product Lifecycle Management (PLM)

Expedite product development and biopharma pipelines with integrated product lifecycle oversight.

Gain strategic oversight of the entire product journey, from inception to post-market through real-time data insights, integrated workflow management, and cross-site collaboration, accelerating product time-to-market and optimizing the entire lifecycle.

Pharma personas like R&D scientists, product managers, and quality assurance professionals, can collaboratively ensure that the product development and product pipelines are streamlined, efficient, and compliant.

R.O.I.

First-year savings for a site of 25 operators:*

Small molecule
$981,193

Large molecule
$960,463

*ROI calculation assumptions — Small Molecule: Number of batch runs = 500; Payroll burden = 50%; Tech transfers to other sites using Tempo: 1. Large Molecule: Number of batch runs = 50; Payroll burden = 50%; Tech transfers to other sites using Tempo: 3.