CDMO Tech Transfer: Semi-Solids & Injectables

Technology transfer to a contract development and manufacturing organisation (CDMO) for semi-solid or sterile injectable pharmaceutical products is a structured, multi-stage programme through which a product’s formulation, manufacturing process and quality control methods are formally conveyed from a sending organisation to a receiving manufacturing site. When executed correctly, it enables the receiving site to reproduce a product that consistently meets its approved quality specifications, at the required scale and under full Good Manufacturing Practice (GMP) compliance. Adragos Pharma provides CDMO services for semi-solid and injectable programmes across a network of GMP-certified facilities in Germany, Switzerland and France, supporting transfers from clinical development through to large-scale commercial supply.

What Technology Transfer Means in a CDMO Context

In pharmaceutical contract manufacturing, technology transfer is not a simple handover of documents. It is a controlled, step-wise programme that transfers product and process knowledge from a sending organisation to a receiving site, while demonstrating that the receiving site can reproduce the product’s critical quality attributes within validated parameters.

The programme is governed by internationally recognised frameworks. The International Council for Harmonisation (ICH) Q10 guideline on Pharmaceutical Quality Systems provides the overarching framework for knowledge management and transfer. ICH Q8 (Pharmaceutical Development) and ICH Q11 (Development and Manufacture of Drug Substances) inform the depth of process understanding expected of the sending party. In Europe, the EU GMP guidelines (EudraLex Volume 4) establish specific obligations for both the sending and receiving sites across three domains:

• Process knowledge transfer: Manufacturing methods, batch records, critical process parameters and in-process control ranges
• Analytical method transfer: Quality control methods, reference standards, acceptance specifications and method validation data
• Quality and regulatory documentation: Dossier summaries, stability data, validation reports and post-approval change strategies

A technology transfer programme that is poorly scoped, under-resourced or lacking senior scientific oversight introduces risk at every subsequent stage of development and supply. Selecting the correct CDMO partner — and understanding the full scope of what transfer requires — is therefore a strategic decision, not a procedural one.

How to Qualify a CDMO Partner for Technology Transfer

Before any transfer activity begins, the pharmaceutical company must conduct a thorough technical and quality qualification of its prospective CDMO. A mismatch in manufacturing scale, dosage form expertise or regulatory standing creates programme risk that is difficult to remediate once a transfer is underway.

GMP Certification and Regulatory Standing

The receiving site must hold a valid GMP manufacturing authorisation issued by the relevant competent authority for each market in which the product will be commercialised. For European markets, EU GMP certification is mandatory. For products with global distribution requirements, certifications from the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) significantly simplify regulatory filings across those markets.

Dosage-Form-Specific Infrastructure

Semi-solid and injectable manufacturing require fundamentally different facility designs, equipment and environmental controls. No amount of general pharmaceutical experience compensates for the absence of validated, dosage-form-specific manufacturing capability. A CDMO must be able to demonstrate active, validated operation in the specific dosage form being transferred, not theoretical capacity.

Quality Management System Maturity

A CDMO’s quality management system must demonstrate robust deviation management, formal change control procedures, structured risk management and a consistent record of regulatory inspection readiness. Inspection outcomes and client audit frequency are reliable indicators of operational quality culture. A site receiving twelve client audits per year, for example, demonstrates a level of transparency and confidence in its quality systems that is difficult to replicate in a site with limited audit history.

Scientific and Technical Team Competence

The expertise of the receiving site’s scientists and manufacturing specialists directly determines the success of the transfer. Experience in formulation development, process characterisation and process validation for the relevant dosage form, accumulated across a significant number of active programmes, is essential and should be verified during qualification.

Good Manufacturing Practice Obligations Governing Technology Transfer

Under EU GMP, technology transfer activities are subject to Chapter 6 (Quality Control), Chapter 7 (Outsourced Activities) and relevant EMA guidance on technology transfer. Annex 15 of the EU GMP guidelines (Qualification and Validation) governs the validation activities that the receiving site must complete prior to commercial manufacture.

Key GMP obligations during a technology transfer include:

• A formal Technology Transfer Protocol defining scope, responsibilities, acceptance criteria, escalation routes and timelines
• A Transfer Report documenting all experimental outcomes, deviations, investigations and sign-off approvals
• Analytical method transfer studies demonstrating that the receiving laboratory can reproduce results from the sending site within pre-established acceptance criteria
• Process validation at the receiving site, structured around the stages defined in Annex 15: Installation Qualification, Operational Qualification, Performance Qualification and, following commercial launch, Continued Process Verification
• Qualified Person oversight and batch release at every GMP manufacturing stage, including for clinical investigational medicinal products

Change control procedures must be invoked whenever a process parameter, material specification or in-process test deviates from what was defined in the Technology Transfer Protocol. Regulatory notification requirements depend on the nature and scope of the change relative to the approved dossier.

The Technology Transfer Process: A Step-by-Step Overview

A structured technology transfer for semi-solid or injectable manufacturing proceeds through defined stages, each of which must be completed and formally reviewed before the next begins.

Stage One: Feasibility Assessment and Gap Analysis

The programme begins with a technical feasibility review. The CDMO assesses whether its facility, equipment portfolio and process knowledge are compatible with the product being transferred. A gap analysis identifies all differences between the originating and receiving sites that must be resolved before experimental work begins.

For semi-solid products, gap analysis addresses mixing and homogenisation equipment compatibility, available batch size ranges, filling equipment formats for the specific primary container and environmental controls for temperature-sensitive formulations. For sterile injectables, gap analysis covers aseptic process design, container closure systems, lyophilisation cycle parameters, filling line compatibility and the regulatory filing requirements across each target market.

Stage Two: Technical Package Review and Documentation Transfer

Once feasibility is established, the sending party provides a comprehensive technical package. This includes master batch records, process descriptions, analytical methods, raw material specifications, stability data, regulatory dossier summaries and validation reports. The receiving site’s technical and quality teams review this documentation in its entirety to identify any gaps, ambiguities or updates required before laboratory or manufacturing work commences.

Stage Three: Analytical Method Transfer

Quality control methods must be formally transferred and verified at the receiving site’s laboratory before any batch manufacture begins. Transfer studies involve comparative testing or co-validation experiments designed to demonstrate equivalent analytical performance between the sending and receiving laboratories within defined acceptance criteria.

For injectable products, this includes sterility testing, endotoxin testing, bioburden determination and High Performance Liquid Chromatography (HPLC) method validation. For semi-solid products, method transfer typically encompasses viscosity determination, pH testing, assay methodology and, where applicable, dissolution or release testing.

Stage Four: Pilot Batch Manufacture

Pilot batches produced at a representative scale allow the receiving site to verify process reproducibility before full-scale manufacture. These batches confirm that equipment parameters, processing conditions and in-process control procedures consistently produce a product meeting the quality specifications established at the originating site. All deviations are formally documented, investigated and resolved through the change management procedures agreed upon at the outset of the programme.

Stage Five: Process Validation and Scale-Up

Process validation at the receiving site must demonstrate that the manufacturing process, when operated within its defined parameter space, consistently produces a product of the required quality. For scale-up programmes, critical process parameters must be evaluated at the intended commercial batch scale to confirm that the product’s critical quality attributes are maintained as equipment geometry, fluid volumes and heat transfer profiles change.

Stability studies initiated during this stage support the regulatory variation or supplement submission required to authorise manufacture at the new site. The scope and filing pathway for that variation will depend on the product’s existing approval status and the regulatory agencies with jurisdiction.

Stage Six: Commercial Supply and Continued Process Verification

Following process validation approval and the resolution of any regulatory filing requirements, the site transitions to routine commercial manufacturing. Continued Process Verification activities monitor process performance data on an ongoing basis to detect trends or signals of process drift, supporting the validated state and the long-term control strategy.

Technical Considerations for Semi-Solid Technology Transfer

Semi-solid pharmaceutical products including creams, gels, ointments and healing pastes present specific technical challenges during technology transfer. Their rheological behaviour, physical stability and in-process characteristics are sensitive to manufacturing variables that do not scale linearly between sites or between batch sizes.

Product Type	Key Technical Challenges at Transfer	Critical Process Parameters
Creams and emulsions	Droplet size distribution, phase separation risk, emulsification efficiency at scale	Temperature during emulsification, mixing speed, homogeniser intensity, cooling rate
Gels	Polymer hydration uniformity, air entrapment, viscosity consistency across batch volume	Hydration time and temperature, mixing sequence, pH adjustment point
Ointments	Active Pharmaceutical Ingredient (API) dispersion uniformity, waxy base behaviour at scale	Temperature of API incorporation, mixing time, batch homogeneity sampling
Healing pastes	High-viscosity handling, equipment shear tolerance, filling accuracy at increased viscosity	Mixing speed, temperature profile, filling pressure and speed

Scale-Dependent Mixing and Homogenisation Behaviour

The fluid dynamics of a semi-solid preparation change materially with increasing batch scale. Shear rates, mixing times and heat transfer rates that produce a given microstructure at pilot scale may not replicate at a larger vessel without process re-characterisation. The receiving site must have the analytical and process development capability to determine appropriate parameter ranges at the intended commercial scale, rather than simply transcribing those from the originating site.

Container and Closure System Compatibility

Semi-solid products are filled into aluminium tubes, plastic tubes and laminate tubes across a range of fill weights. The receiving site must operate validated filling equipment that is compatible with the specific container format, fill weight range and sealing mechanism required. Line clearance procedures and in-process fill weight controls must be aligned with the product’s specifications from the outset.

Environmental and Temperature Controls

Many semi-solid formulations require controlled temperature conditions during bulk manufacture, transfer and filling. The manufacturing facility must demonstrate validated environmental control systems that maintain the required conditions throughout each stage of the process.

Physicochemical Stability and Acceptance Testing

Rheological properties including spreadability, consistency, appearance and phase homogeneity are key quality attributes for semi-solid products and must be incorporated into the stability programme initiated at the receiving site. Stability chambers must be qualified to support the ICH climate zones relevant to the target markets.

Technical Considerations for Sterile Injectable Technology Transfer

Sterile injectable manufacturing operates within the most demanding regulatory and technical environment in pharmaceutical production. Technology transfer for liquid vials, lyophilised vials, prefilled syringes and ampoules requires precise process characterisation and rigorous contamination control at every stage.

Injectable Format	Key Technical Challenges at Transfer	Critical Considerations
Liquid vials	Sterility assurance, container closure integrity, particulate control	Aseptic process design, fill volume accuracy, stopper compatibility
Lyophilised vials	Cycle transfer between freeze-dryers of differing geometry and capacity	Collapse temperature data, residual moisture targets, shelf temperature uniformity
Prefilled syringes	Container system compatibility, plunger functionality, breakloose and glide force	Syringe barrel material, silicone level, tip cap and needle integration
Ampoules	Sealing integrity, particulate generation during sealing, terminal sterilisation compatibility	Fill volume control, sealing conditions, pinhole detection validation

Aseptic Process Design and Simulation

For products requiring aseptic manufacture, the receiving site must operate within a validated aseptic processing environment and demonstrate its sterility assurance through formal Aseptic Process Simulation, commonly referred to as a media fill study. The design of the filling environment, including the use of Restricted Access Barrier Systems (RABS) or isolator technology, must be evaluated for compatibility with the specific product’s viscosity, filling volume and container format.

Lyophilisation Cycle Development and Transfer

For freeze-dried products, the lyophilisation cycle is a critical process parameter set that must be fully characterised at the receiving site. Differences in freeze-dryer shelf area, condenser capacity, vacuum system performance and control system architecture between the originating and receiving equipment may require cycle re-development and formal comparability studies. Residual moisture targets and collapse temperature data established during development must be reproduced under the receiving site’s conditions.

Container Closure Integrity Evaluation

The combination of primary container and closure must be evaluated for compatibility with the product formulation and validated for integrity across the intended shelf life. For prefilled syringes, this includes assessment of the syringe barrel material, plunger configuration, tip cap and, where relevant, the attached needle system. Container closure integrity testing methodology and acceptance criteria must be established and validated at the receiving site.

Regulatory Variation and Dossier Submissions

A change of manufacturing site for a sterile injectable product requires a regulatory variation or supplement submission to each authority with jurisdiction over the approved product. The classification of that variation, and therefore the data package required, depends on the product’s regulatory history, the nature of the change and the market concerned. CDMOs with active regulatory affairs experience across the relevant geographies provide meaningful support in scoping, preparing and filing these submissions.

Controlled Substance Handling

Where the injectable product contains a controlled substance, the receiving site must hold the appropriate national narcotic handling licence and demonstrate validated procedures for secure storage, weighing, dispensing and reconciliation throughout the manufacturing process. Regulatory authorities require full accountability records across all controlled substance operations.

How Adragos Pharma Supports Technology Transfer in Practice

Semi-Solid and Non-Sterile Liquid Manufacturing: Adragos Leipzig, Germany

The Leipzig facility was founded in 1926 and operates across 13,300 m² of production area. The site holds EU GMP certification for both human and animal pharmaceutical products and specialises in semi-solid and non-sterile liquid manufacturing.

For semi-solid products, two production lines equipped with Marchesini and Norden machinery support batch sizes from 15 to 1,250 litres across creams, gels, ointments and healing pastes. Packaging capability includes aluminium tubes (2 g to 150 g), plastic tubes (25 g to 200 g) and laminate tube formats. For non-sterile liquid products, three production lines (Dovema, Groninger and Würschum) support batch sizes of up to 4,000 litres. Plastic and glass bottle formats from 20 mL to 700 mL are available. The site also handles controlled substances.

Technology transfer services at Leipzig encompass:

• Galenical development and transfer management
• Pilot batch manufacture
• Global raw material procurement
• Production and secondary packaging
• Analytical and batch release testing, including method transfer
• Stability studies for ICH climate zones II, IVa and IVb
• Process validation and product quality reviews
• Serialisation in accordance with the EU Falsified Medicines Directive
• Qualified Person-certified batch release, including for clinical investigational medicinal products

Analytical capabilities include HPLC, Gas Chromatography (GC), GC headspace analysis, ultraviolet-visible spectrophotometry and titration.

Clinical and Commercial Sterile Fill-and-Finish: Adragos Jura, Switzerland

The Jura facility has more than 25 years of specialisation in aseptic fill-and-finish for liquid and lyophilised vials, serving both clinical trial material programmes and small-to-medium scale commercial supply. The site is certified by the EMA, the FDA and Swissmedic, and produces approximately 200 clinical batches per year across a broad client base ranging from large pharmaceutical companies through to early-stage biotechnology firms.

There is no minimum batch size restriction; lyophiliser capacity accommodates up to 74,400 vials across freeze-dryers of 3 m² and 9 m² capacity. Vial formats range from 2R to 30R. The site operates RABS for aseptic processing, supports both peristaltic and rotary piston filling pumps and uses a single-use strategy that reduces cleaning validation burden and cross-contamination risk. A standard turnaround from order to batch is three months, including for programmes involving controlled substance handling.

Technology transfer at Jura is supported across the following stages:

• Technical and GMP feasibility assessment
• Preclinical material preparation and toxicology study support
• Pilot batch manufacture and process alignment
• Full GMP manufacturing, secondary packaging and clinical kit preparation
• GMP storage and temperature-controlled shipment of analytical samples
• Long-term stability storage and testing under ICH conditions

Analytical services include HPLC validation, sterility suitability testing, endotoxin suitability testing and bioburden suitability testing.

Large-Scale Commercial Injectable Manufacturing: Adragos Maisons-Alfort, France

For programmes transitioning from clinical to high-volume commercial injectable supply, the Maisons-Alfort facility in France provides large-scale sterile manufacturing with over 77 years of operational experience. The site holds EU GMP certification and is certified by 12 international health authorities.

Two filling lines equipped with RABS produce prefilled syringes at up to 540 units per minute, with an annual capacity of 150 million units across three syringe formats: Standard, Preventis™ and Eris™. For liquid and lyophilised vials, a single filling line operates at up to 300 vials per minute, supported by two large automated loading and unloading freeze-dryers accommodating up to 74,000 vials. Automated inspection is performed by two Seidenader lines at up to 600 units per minute. The site operates with Clean-In-Place and Sterilise-In-Place systems and provides fully compliant Aseptic Process Simulation services.

Ampoule and Suppository Manufacturing: Adragos Livron, France

The Livron facility, with over 110 years of manufacturing experience, specialises in sterile liquid ampoules and suppositories. Four production lines, two equipped with RABS for aseptic filling and two for terminal sterilisation by heat, provide an annual ampoule capacity of 120 million units. Batch sizes range from 30 to 1,500 litres across ampoule formats from 1 mL to 10 mL. Three fully automated visual inspection lines provide optical, cosmetic and pinhole detection. For suppositories, two filling machines and a packaging line accommodate batch sizes from 100 kg to 2,000 kg, producing suppositories and ovules from 0.9 g to 46 g. Controlled substance handling is available across both product formats.

Selecting the Right Site for Your Technology Transfer Programme

When evaluating CDMO services for a technology transfer programme, site selection should be driven by dosage form expertise, available batch scale, analytical capability and the regulatory certifications required for the target markets. A CDMO operating a network of complementary sites, each with validated capability in its specialist dosage form, provides the additional advantage of continuity: a product can progress from clinical trial material manufacturing through to large-scale commercial supply without the regulatory and operational disruption of changing partner.

Adragos Pharma’s European manufacturing network, spanning Leipzig, Jura, Maisons-Alfort and Livron, provides this continuity across semi-solid, non-sterile liquid and sterile injectable dosage forms. For programmes requiring access to the Japanese market, the Kawagoe facility provides visual inspection and packaging services aligned with the stringent requirements of Japan’s Ministry of Health, Labour and Welfare and the PMDA, acting as a final quality gateway for products entering Japan from European or United States manufacturing sites.

To discuss how the Adragos Pharma manufacturing network can support your technology transfer programme, contact the Adragos team directly.

Frequently Asked Questions

What is technology transfer in pharmaceutical manufacturing?

Technology transfer in pharmaceutical manufacturing is the structured, documented process by which a product’s formulation, manufacturing method and quality control procedures are formally conveyed from an originating organisation to a receiving manufacturing site. It is governed by international frameworks including ICH Q8, Q10 and Q11 guidelines and requires formal documentation, analytical method transfer, pilot batch manufacture and process validation at the receiving site before commercial production can commence.

What are the key steps in a CDMO technology transfer for semi-solid and injectable products?

The key steps are: technical feasibility assessment and gap analysis; technical package review and documentation transfer; analytical method transfer; pilot batch manufacture; process validation and scale-up; and transition to commercial supply with Continued Process Verification. Each stage must be formally completed and reviewed before the next begins. The entire programme is underpinned by a Technology Transfer Protocol agreed upon at the outset and a Transfer Report produced at its conclusion.

What GMP regulations apply to technology transfer in Europe?

In Europe, technology transfer activities are governed by the EU GMP guidelines, specifically Chapter 6 (Quality Control), Chapter 7 (Outsourced Activities) and Annex 15 (Qualification and Validation). EMA guidance on technology transfer provides additional procedural requirements. All manufacturing stages require oversight and batch certification by a Qualified Person.

What is the difference between a technology transfer for semi-solid and injectable products?

Semi-solid technology transfer focuses primarily on controlling rheological behaviour, mixing uniformity, homogenisation efficiency and scale-dependent heat transfer. Injectable technology transfer requires sterility assurance through validated aseptic process design, container closure integrity evaluation and, for lyophilised products, freeze-dryer cycle characterisation at the receiving site. Injectable transfers also carry more complex regulatory variation requirements due to the sterile classification of the product and the greater number of critical process parameters involved.

What documentation is required for a pharmaceutical technology transfer?

Required documentation from the sending organisation includes master batch records, process descriptions, analytical methods, raw material specifications, stability data, regulatory dossier summaries and validation reports. The receiving site must produce a formal Technology Transfer Protocol, transfer study reports, analytical method transfer reports and, following pilot batch manufacture, a process validation plan and report. All documentation must meet the standards required by the relevant regulatory authorities for the target markets.

Does Adragos Pharma support both clinical and commercial scale technology transfer?

Yes. Adragos Pharma supports technology transfer programmes at both clinical and commercial scale. The Jura facility in Switzerland handles clinical trial material manufacturing with no minimum batch size restriction and a standard three-month turnaround from order to batch, including for controlled substance programmes. Maisons-Alfort in France provides large-scale commercial sterile fill-and-finish for prefilled syringes and vials. Leipzig in Germany offers semi-solid and non-sterile liquid manufacturing from 15 litres through to 4,000 litres at commercial scale.

What analytical methods are available to support technology transfer at Adragos facilities?

At Adragos Leipzig, analytical methods include HPLC, GC, GC headspace analysis, ultraviolet-visible spectrophotometry and titration, alongside microbiological testing including Total Aerobic Microbial Count and Total Yeast and Mould Count determination. At Adragos Jura, available methods include HPLC validation, sterility suitability testing, endotoxin suitability testing and bioburden suitability testing. Method development, validation and formal transfer are included within the analytical service offering at both sites.

Does Adragos Pharma handle controlled substances during technology transfer?

Yes. Adragos Leipzig handles controlled substances for semi-solid and non-sterile liquid products. Adragos Jura includes controlled drug handling within its standard three-month order-to-batch turnaround for sterile injectable programmes. Adragos Livron also handles controlled substances for ampoule and suppository manufacturing.

What stability testing zones are supported across the Adragos network?

Adragos Leipzig provides stability testing for ICH climate zones II, IVa and IVb, with alarm-controlled temperature and humidity monitoring and a computer-aided scheduling and data management system. Studies are available during both clinical development and post-approval stages. Adragos Jura provides long-term stability storage under ICH conditions, with analytical testing at intermediate and final stability time points, covering the full product lifecycle from development through distribution.

How does Adragos Pharma support market entry into Japan?

Adragos Pharma supports Japanese market entry through its Kawagoe facility in Japan, which provides visual inspection and packaging services to meet the stringent quality requirements of Japan’s Ministry of Health, Labour and Welfare and the PMDA. For pharmaceutical companies manufacturing at European or United States sites, Adragos can manage bulk preparation at the relevant Adragos facility and transfer products to Kawagoe for final visual inspection and packaging in Japan, supporting both co-marketing and Designated Marketing Authorisation Holder arrangements.