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Solutions for Biotechnology

Biotechnology

Overcome your validation challenges and drive efficiency, compliance, and cost savings with Kneat

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Biogen Inc.

Biogen’s lab of the future

Biogen digitalized analytical instrument validation to deliver their “Lab of the Future” vision, achieving greater efficiency, data integrity, and compliance.

use cases

  • Analytical Instrument Validation Analytical Instrument Validation

A top 10 biotech leader

Transforming traceability to improve risk mitigation

The customer, a rapidly expanding biotechnology company with over 45,000 employees achieved an 88% time saving on URS, reducing the cycle time from 2 months...

use cases

  • Commissioning & Qualification Commissioning & Qualification
  • Equipment Validation Equipment Validation

ElevateBio

Enabling ElevateBio’s industry-disrupting business model

ElevateBio reduced cycle times by 50%, accelerated manufacturing changeovers, and delivered top-tier quality assurance with Kneat.

use cases

  • Commissioning & Qualification Commissioning & Qualification
  • Computer System Validation Computer System Validation
  • Equipment Validation Equipment Validation

Multinational Biopharma

Digitalizing validation worldwide

A global biopharma leader digitalized validation with Kneat Gx across 25+ global sites and thousands of users, achieving 24/7 visibility, audit-friendly processes, and faster product...

use cases

  • Analytical Instrument Validation Analytical Instrument Validation
  • Cleaning Validation Cleaning Validation
  • Commissioning & Qualification Commissioning & Qualification
  • Computer System Validation Computer System Validation
  • Equipment Validation Equipment Validation
  • Method Validation Method Validation
Biogen’s lab of the future

Biogen digitalized analytical instrument validation to deliver their “Lab of...

Transforming traceability to improve risk mitigation

The customer, a rapidly expanding biotechnology company with over 45,000...

Enabling ElevateBio’s industry-disrupting business model

ElevateBio reduced cycle times by 50%, accelerated manufacturing changeovers, and...

Digitalizing validation worldwide

A global biopharma leader digitalized validation with Kneat Gx across...

Trusted By

Common Validation Challenges

Solving Biotech validation challenges

Process variability

Biotechnology processes often involve living organisms, introducing inherent variability. Validation professionals must develop strategies to control and minimize this fluctuation to ensure consistent product quality. Kneat enables best-practice controls for variability.

Analytical method complexity

Complex molecules require sophisticated analytical techniques that produce more data, increasing testing burden. Kneat’s powerful, automated data management features de-risk, simplify, and streamline method validation.

Scalable processes

Transitioning processes from laboratory scale to full-scale manufacturing without compromising product quality or efficacy requires thorough validation to address potential scale-up issues. Kneat enables efficient verification to enable the fastest possible testing during expansion.

Compliance for novel therapies

The rapid rise of therapies like gene and cell therapies often outpaces regulation. Documentation must be flexible to navigate these uncharted areas to ensure compliance with evolving frameworks. Kneat provides the flexibility to easily update templates and workflows as needs change.

The flexibility of Kneat is huge ... if we want to onboard a new client, it’s a 15-minute meeting between us, and we set it up how we want. We update our process mapping document, and we move on.

- Laura Berberian, Manager, Quality Assurance Validation, ElevateBio

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Solutions by industry

Our expert team and industry-leading solution help pharma quality assurance and validation teams overcome compliance and operational challenges every day.

Get more products to market faster without compromising quality. Improve the efficiency of the entire validation lifecycle for all your consumer health products.

Overcome complexity across process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations.

Transform the efficiency and compliance of design, process, software, cleaning, equipment, packaging, sterilization, and test method validation.

Accelerate release to production and ensure customer confidence with more efficient, transparent documentation. Perform technology transfer and meet deadlines faster and easier.

Revolutionize your validation

Digitalize validation your way, with the validation platform trusted by the world’s leading life sciences companies.

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