Bielefeld is NextPharma’s Centre of Excellence for modified-release products, with a dedicated focus on Modified Release (MR) technology since 1992. Formulation development, technology transfer and commercial manufacturing are all on the same site, so a controlled-release product moves from early formulation through scale-up to commercial supply without a facility change.
NextPharma Bielefeld covers the process steps that complex modified-release forms depend on:
Pellet production by extrusion and spheronisation, and by layering onto non-pareils
Granulation
Film coating and enteric coatings
Tabletting of pellets: MR matrix and pellet-in-tablet forms
Encapsulation of multiple components in one capsule: various pellets; pellets with powders or granules; pellets with tablets
Aqueous and organic film coating
Packaging: blisters and stick packs with secondary packaging
Multi-component capsules and pellet-in-tablet forms require combined pelletising, coating and assembly capability in one place. Splitting these steps across sites introduces variability that MR release profiles are sensitive to. Keeping extrusion, layering, coating and assembly under one roof is what makes reproducible release profiles achievable at commercial scale.
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NextPharma Bielefeld takes a controlled-release product through a defined sequence on one site:
Pre-formulation: API characterisation and excipient compatibility
Analytical development: method development, validation and transfer, including dissolution and stability-indicating methods
Formulation: pellet, matrix and coated MR forms; release-profile design
Process development: extrusion, spheronisation, layering and coating parameters
Clinical supplies: production of clinical batches under GMP
Scale-up: process robustness, validation and cleaning verification
Industrialisation: registration batches, full validation and ICH stability studies conducted on site to support registration and commercial release
Most CDMOs separate formulation development from commercial manufacturing, which means the coating conditions and process parameters that define a release profile have to be re-established at a receiving site after tech transfer. At NextPharma Bielefeld, that transfer does not happen: the same site that develops the MR formulation scales it up and produces it commercially.
The process parameters and coating conditions established during development carry directly into commercial batches. For products where release-profile reproducibility is the critical quality attribute, this continuity materially reduces development and validation risk. For broader context on how development and manufacturing connect across the network, see Pharmaceutical Development and the Commercial Manufacturing and Packaging hub.
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Manufacturing and analytical work at Bielefeld are performed according to EMA, FDA-approved analytical services, ANVISA and ICH requirements.
Commercial sites network and capabilities
Commercial activities are supported by specialist centres of excellence across Europe, each aligned to specific technologies and dosage forms.
Scoping an MR project starts with the release mechanism, target dosage form and intended scale. Talk to our modified-release team at Bielefeld to discuss formulation strategy, coating approach, scale-up and commercial manufacture for your controlled-release product.
Whether it's development, manufacturing or supply. Tell us about your project and our experts will get back to you.
