Streamline Innovation with BioBoston Consulting Technology Transfer Services

Overview

Technology transfer ensures reliable, compliant movement of product and process knowledge from development to commercial manufacturing or between manufacturing sites. BioBoston Consulting delivers structured, risk‑based technology transfer services that preserve product quality, accelerate scale‑up, and maintain regulatory compliance.

Core Technology Transfer Services

• Transfer planning and strategy including roadmaps, timelines, and site capability assessments.
• Process and analytical method transfer with protocol development and tech transfer packages.
• Equipment qualification and process validation including IQ OQ PQ execution and qualification reporting.
• Documentation and SOP alignment with master batch records, control strategies, and traceability.
• Training and knowledge transfer for operations, quality, and analytical teams.
• Regulatory support for submissions, inspections, and change control documentation.

Why Technology Transfer Matters

• Regulatory compliance ensures manufacturing meets FDA EMA and global requirements.
• Product consistency maintains safety, efficacy, and batch-to-batch reproducibility.
• Operational efficiency reduces scale‑up delays, errors, and costs.
• Market readiness accelerates time‑to‑market through reliable production transfers.
• Risk mitigation identifies and resolves issues before they impact product supply.

Technology Transfer Best Practices

Adopted best practices include robust transfer project management, early alignment on critical quality attributes and control strategies, comprehensive analytical method validation, and thorough site readiness assessments. These practices minimize transfer risk and improve reproducibility during scale‑up and site changesFDA Database.

Industries and Use Cases

• Small molecule pharmaceuticals and sterile injectables.
• Biologics and cell and gene therapies.
• Medical devices and combination products.
• Contract manufacturing organization (CMO) onboarding and supplier transfers.
• Process scale‑up from pilot to commercial manufacturing.

Partner with BioBoston Consulting to execute risk‑based, compliant technology transfers that enable scale and market readiness. Contact BioBoston Consulting now to schedule a technology transfer assessment, request a tech transfer package template, or start a site qualification plan.