Protect Your Brand™

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Protect Your BrandTM

Is a unique offering designed to support pharma-biotech companies pursuing a dual source strategy. Under this program, Alcami will support tech transfer and validation of products in advance of potential manufacturing needs without any long-term commitment or minimum annual volume. It's that simple. This service can be used for drug substance, drug product and for clinical supplies, launch quantities, and commercial supply. Alcami can be ready quickly to bridge unexpected gaps in your critical supply needs.

Secure Your Supply Chain

As supply chain complexity grows, risks continue to mount. From quality issues and drug shortages to warning letters and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Alcami makes securing your supply easier than ever with Protect Your Brand.

  • Technology Transfer start within 1 month of inquiry
  • No Annual Purchase Obligation
  • No Long Term Contract
  • Annual Product GAP Assessment
  • Ongoing Readiness and Emergency Responsiveness
  • Clinical and Commercial Supply
  • Drug Substance, Drug Product and Packaging
  • Biologics and Small Molecules

The Alcami Advantage

When developing a dual sourcing strategy, validation of processes with a trusted and reliable supplier, like Alcami, protects against supply chain disruptions.

  • Broad in-house technical and regulatory expertise
  • Innovative solutions for timelines and technical challenges
  • Excellent track record of regulatory compliance across numerous agencies
  • Full service, integrated CDMO who works on >200 molecules annually
  • Flexibility and agility to respond to your needs quickly
  • Successful CDMO approval for all filings to date
  • State of Alcami Readiness™ Proprietary Scoring System

Complete Offerings From Start to Finish

Protect Your Brand offers three distinct dual supply solutions to prevent disruptions
from occurring at the earliest concept through to post-commercial production.

Concept to Clinic Commercial Post-Commercial / Secondary Supply
Formulation
Process
Scalability
Stability
Supply Chain Security
Line Extension
• Raw Material Vendor Qualification
• Methods Transfer Report
• Clinic Ready Product
• IND Update Support
• Product GAP Assessment
• Raw Material Vendor Qualification
• Methods Transfer Report
• Registration Batches for Filing
• Regulatory Filing Support
• Product GAP Assessment
• Raw Material Vendor Qualification
• Methods Transfer Report
• Validation Batches for Filing
• Regulatory Filing Support
• Line Extension Support
• Product GAP Assessment

  

Assess Your Risk, Assign Our Readiness

All products are unique and every process carries its own risks. Protect
Your Brand allows you to determine the ideal State of Alcami Readiness.
By responding quickly, Alcami can minimize the effects of a supply disruption,
helping to prevent shortages and delays. We do this by using our proprietary
State of Alcami Readiness scoring system and cover it in our annual state of
readiness meeting.

Annual State of Readiness Meeting Topics:

Inputs:
Client defines desired Process

GAP Assessment of the Defined Process

  • Technical Review of Process for Facility Fit
  • Review of Analytical Methods and Fit for Purpose
  • Review of Batch Records for State of Readiness
  • Regulatory Change/Process Validation Assessment
  • Supply Chain/Vendor Status Assessment
  • Trending of available Stability Data

State of the Product

  • Filing Status
  • Demand Profile

Outputs:

  • Current Risk Level and Readiness Summary
  • Alcami provides strategy for each State of Alcami Readiness level
  • Alcami and Client determine desired State of Alcami Readiness level
  • Execute plan to reach desired State of Alcami Readiness level

State of Alcami Readiness Proprietary Ranking System assesses:

Readiness of:

  • Raw materials and Vendor status
  • Test methods and specifications
  • Process and Facility Fit

Risk Factors:

  • Client’s Current SituationPYB_Lifesaver.png
  • Product Phase
  • Capacity Needs
  • Client Supplied Material Availability

    Download Our Protect Your Brand™ Brochure