Tech Transfer
Seamless Tech Transfers for Semi-Solid and Non-Sterile Liquid Drug Products
Tech-transferring semi-solid and non-sterile liquid products is high stakes, given that small shifts in mixer geometry, shear, heat transfer, or filling can alter rheology, stability, and dose uniformity. Meeting and exceeding leading regulators’ technology transfer expectations, CPL starts with a robust gap and risk analysis, then runs lab, pilot, and commercial-scale batches, conducts appropriate compatibility studies, and ultimately locks in scalable, cGMP-ready processes. This integrated approach is why our product development team, formulators, and analytical scientists work together in the tech transfer process right from the start.
CPL’s Thorough Gap Analysis Mitigates Tech Transfer Risks
At the beginning of every tech transfer project, CPL performs a comprehensive gap analysis to reduce risks early. We assess safety hazards, compare the sending site’s equipment with ours for capacity and capability, material of construction, and operating principles, and review the process to determine differences in scale, equipment capabilities, or containment while linking CPPs to CQAs. We verify that analytical methods, SOPs (standard operating procedures), and MWOs (manufacturing work orders) are reproducible at our facilities, assess team expertise and training needs, and confirm that process histories and flow charts are available to replicate performance.
CPL Experience Spotlight
Complex Nasal Spray Tech Transfer
Dedicated to Excellence
from Molecule to Commercialization
CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.
Pharmaceutical Development Services
Pharmaceutical Development Services
Comprehensive expertise that turns molecules into scalable, compliant, market‑ready semi-solid and non-sterile therapies.
Analytical & Product Testing
Analytical & Product Testing
Robust analytics power confident development and manufacture of topical and non-sterile liquid products.
Clinical & Commercial Manufacturing
Clinical & Commercial Manufacturing
More than three decades of GMP manufacturing experience from clinical supply through commercialization.
Packaging, Labeling & Serialization
Packaging, Labeling & Serialization
Integrated packaging, serialization, and aggregation ensure compliant, continuous commercial supply.
Semi-Solid & Non-Sterile Liquid Expertise
Semi-Solid & Non-Sterile Liquid Expertise
Pure-play CDMO for semi-solids and non-sterile liquids, with advanced micro encapsulation capabilities.
Unique Product Handling Experience
Unique Product Handling Experience
Infrastructure and expertise to manage complex, higher-risk semi-solid and non-sterile liquid products.
FAQs
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Tech transfer in the pharmaceutical industry is the structured handover of product and process knowledge from development or another site into cGMP manufacturing. For semi-solids and non-sterile liquids, it’s essential to maintain rheology, dose uniformity, preservative effectiveness, release profile, and container closure compatibility during tech transfer and scale-up. A robust tech transfer links critical process parameters (CPPs) to critical quality attributes (CQAs), supports process validation, and reduces the risk of failures during clinical supply, registration batch manufacturing, and commercial production.
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CPL follows a rigorous gap and risk-based tech transfer process. We compare sending-site and CPL equipment, containment, utilities, and container closure systems; assess analytical method validation status; and review SOPs, batch records, and historical data to identify gaps before execution. Lab- and pilot-scale batches, polymeric contact-part studies, and scale-up runs define CPPs and establish design spaces. This methodical approach helps avoid surprises during clinical manufacturing, PPQ, and commercial manufacturing of ointments, creams, gels, nasal sprays, and oral suspensions.
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Regulators expect clear evidence that the manufacturing process is understood, controlled, and reproducible. This includes gap/risk assessments, equipment qualification in pharmaceutical industry settings, validated analytical methods, batch records, process validation protocols, and reports linking CPPs to CQAs. For semi-solid and non-sterile liquid products, data on mixing, heating/cooling, filling, microbial control, and container closure integrity are critical. CPL generates audit-ready documentation to support IND, IMPD, NDA, ANDA, and post-approval changes, aligning with Health Canada, FDA, EMA, and ICH expectations for pharmaceutical process validation.
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Collaboration as early as possible allows our teams to review pharmaceutical formulation development data, stability and storage information, and analytical methods, and to design a tech transfer process that supports both clinical trial manufacturing and commercial scale-up. Early involvement helps address pharmaceutical tech transfer challenges before they threaten timelines or regulatory approval. Additionally, CPL’s decades of experience successfully performing tech transfers can guide our customers on what’s required for an effective, efficient transfer that meets regulatory requirements.
Commitment.
Partnership. Legacy.
Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.
