Preformulation & formulation development
Material properties, formulation options and product-specific development questions.
PlannedCatalogue scope
Capabilities · Planned catalogue
Planned capabilities for a pharmaceutical plant.
The catalogue organises, by family, the manufacturing, analytical, regulatory and supply services under consideration for the Boten project. A planned catalogue for scoped evaluation. Inclusion does not establish installed, qualified, licensed or available capability.
Planned capabilitiesPlanned
One catalogue. Every line Planned.
13 families and 75 named planning entries. 7 entries belong to the initial project scope documented in the 15 June 2026 plan; the others are catalogue scope, a proposed expansion that requires confirmation.
Catalogue reviewed · no service carries a launch date
- Service status
- Planned throughoutNone available
- Initial project basis
- Two modules · 15 June 2026Initial project scope
- Wider catalogue
- Proposed expansionScope confirmation required
- Facility roadmap
- First commercial batch target Q1 2028 · indicativeNot a service date
01 · Reading the catalogue
Two labels on every line.
Each entry shows its status and its basis, so a planned line is never read as an available one.
- Planned
- Every entry is a planning entry. No service is available, installed or qualified.
- Initial project scope
- The entry corresponds to the two modules and five presentation families documented in the 15 June 2026 project plan.
- Catalogue scope
- A proposed expansion for technical discussion. Scope confirmation is required before the entry could be offered.
- Facility roadmap
- The project roadmap is separate. First commercial batch target Q1 2028 · indicative; it is not a service date.
Catalogue boundary
A planned catalogue for scoped evaluation. Inclusion does not establish installed, qualified, licensed or available capability. Counts on this page are planning entries computed from the catalogue, not capability counts.
02 · Catalogue
Thirteen families of planned services.
75 planning entries in 13 families. Open a family to read its entries.
Product & process development5 planning entries · all Planned
Product & process development
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Process development & scale-up
Process definition, scale considerations and the evidence needed for transfer.
PlannedCatalogue scope
Container-closure development
Compatibility, presentation and container-closure questions for the exact product.
PlannedCatalogue scope
Lyophilisation cycle development
Product-specific cycle design and evidence requirements.
PlannedCatalogue scope
Clinical & investigational supply development
Study-specific manufacturing, packaging and documentation requirements; permissions remain separate.
PlannedCatalogue scope
Oral solid dosage forms6 planning entries · all Planned
Oral solid dosage forms
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Tablets
Compression, coating and tablet-presentation scope.
PlannedCatalogue scope
Hard capsules
Powder, granule or multiparticulate capsule presentations.
PlannedCatalogue scope
Soft capsules
Formulation, encapsulation and stability scope.
PlannedCatalogue scope
Powders & granules
Blending, granulation, unit-dose sachets and bulk presentations.
PlannedCatalogue scope
Pellets & multiparticulates
Particle-based presentations and their process-control needs.
PlannedCatalogue scope
Modified-release & oral films
Product-specific release design and film presentations; performance cannot be inferred.
PlannedCatalogue scope
Liquid dosage forms4 planning entries · all Planned
Liquid dosage forms
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Oral solutions & syrups
Solution preparation, handling and filling considerations.
PlannedCatalogue scope
Suspensions & emulsions
Dispersion, mixing, homogeneity and filling scope.
PlannedCatalogue scope
Oral drops
Dropper presentation and container compatibility.
PlannedCatalogue scope
Topical solutions & washes
Liquid topical presentations with product-specific controls.
PlannedCatalogue scope
Semi-solids & specialised presentations4 planning entries · all Planned
Semi-solids & specialised presentations
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Creams & ointments
Mixing, homogenisation, transfer and tube or container filling.
PlannedCatalogue scope
Gels & lotions
Rheology, uniformity and presentation-specific handling.
PlannedCatalogue scope
Suppositories & pessaries
Moulded presentations and their formulation and process requirements.
PlannedCatalogue scope
Transdermal patches
Patch presentation, drug-delivery design and product-specific evidence.
PlannedCatalogue scope
Sterile products & aseptic filling10 planning entries · all Planned · 6 in the initial project scope
Sterile products & aseptic filling
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Aseptic filling of vials
Product preparation, filling, closure and visual-inspection scope.
PlannedInitial project scope
Aseptic filling of ampoules
Filling, sealing and inspection of ampoule presentations.
PlannedInitial project scope
Single-chamber cartridges
Cartridge presentation, filling and closure interfaces.
PlannedInitial project scope
Dual-chamber cartridges
Separated components and the presentation-specific filling sequence.
PlannedInitial project scope
Prefilled syringes
Syringe filling, component compatibility and closure controls.
PlannedCatalogue scope
Lyophilisation
Freeze-drying as part of a product-specific manufacturing process.
PlannedInitial project scope
Sterile powders for injection
Powder processing and filling with the required containment and contamination controls.
PlannedCatalogue scope
Oil-based vial injections
Product-specific compounding and vial-filling requirements.
PlannedInitial project scope
Large-volume parenterals
Container, process and sterilisation-route assessment.
PlannedCatalogue scope
Terminal sterilisation
Suitability of the product, container and proposed sterilisation process.
PlannedCatalogue scope
Ophthalmic, inhaled & other delivery forms5 planning entries · all Planned
Ophthalmic, inhaled & other delivery forms
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Ophthalmic preparations
Eye-drop, gel or ointment presentations and required contamination controls.
PlannedCatalogue scope
Otic & nasal preparations
Drop or spray presentations with product-specific delivery requirements.
PlannedCatalogue scope
Nebuliser solutions
Solution, container and delivery-interface requirements.
PlannedCatalogue scope
Metered-dose & dry-powder inhalers
Device interfaces, dose delivery and formulation-specific development.
PlannedCatalogue scope
Combination products & injector devices
Drug-device interfaces, assembly and presentation-specific verification.
PlannedCatalogue scope
Drug substance & biological inputs5 planning entries · all Planned · 1 in the initial project scope
Drug substance & biological inputs
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Protein raw-material production & purification
A separate planned module identified in the initial Boten project brief.
PlannedInitial project scope
Small-molecule active ingredients
Proposed synthesis, isolation and purification domains; scope confirmation required.
PlannedCatalogue scope
Fermentation & biological processing
Proposed upstream and downstream processing domains.
PlannedCatalogue scope
Peptide & oligonucleotide processing
Proposed specialist synthesis and purification domains.
PlannedCatalogue scope
Biological drug-substance development
Proposed biological process and material-characterisation scope.
PlannedCatalogue scope
Specialist manufacturing domains4 planning entries · all Planned
Specialist manufacturing domains
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Highly potent & cytotoxic products
Dedicated risk, containment and facility-segregation assessment.
PlannedCatalogue scope
Sensitising compounds & beta-lactams
Product-family segregation and contamination-control assessment.
PlannedCatalogue scope
Hormonal products
Product-specific containment, cleaning and segregation assessment.
PlannedCatalogue scope
Controlled-substance handling
Separate legal permissions, security and material-accountability requirements.
PlannedCatalogue scope
Packaging, assembly & serialisation6 planning entries · all Planned
Packaging, assembly & serialisation
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Primary packaging
Blisters, bottles, sachets, tubes and presentation-specific container systems.
PlannedCatalogue scope
Secondary packaging
Cartoning, labelling, leaflet insertion and pack configuration.
PlannedCatalogue scope
Device assembly
Assembly interfaces for delivery devices and combination presentations.
PlannedCatalogue scope
Serialisation & aggregation
Identification, data exchange and market-specific pack traceability.
PlannedCatalogue scope
Artwork & labelling control
Artwork versioning and presentation-information control.
PlannedCatalogue scope
Packaging qualification
Packaging suitability, compatibility and distribution-related evidence.
PlannedCatalogue scope
Analytical & stability services8 planning entries · all Planned
Analytical & stability services
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Analytical method development
Product-specific test methods and analytical development questions.
PlannedCatalogue scope
Method transfer & validation
Transfer protocols, method performance and agreed acceptance criteria.
PlannedCatalogue scope
Raw-material & finished-product testing
Material identity, specifications and product-specific test scope.
PlannedCatalogue scope
Microbiological testing
Methods, materials and facility conditions relevant to the proposed activity.
PlannedCatalogue scope
Sterility, endotoxin & particulate testing
Product-specific methods, laboratories and applicable evidence requirements.
PlannedCatalogue scope
Stability studies
Study design, conditions, sampling and product-container relevance.
PlannedCatalogue scope
Container-closure integrity testing
Presentation-specific integrity questions and the supporting method.
PlannedCatalogue scope
Impurities & extractables / leachables
Product, material and packaging-related analytical questions.
PlannedCatalogue scope
Technology transfer & contract manufacturing6 planning entries · all Planned
Technology transfer & contract manufacturing
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Technology transfer
Product knowledge, process information and responsibilities for a proposed transfer.
PlannedCatalogue scope
Contract development
A scoped programme for formulation, process and analytical development.
PlannedCatalogue scope
Contract manufacturing
Future product-specific manufacturing arrangements, subject to readiness and permissions.
PlannedCatalogue scope
Clinical & commercial batch programmes
Distinct batch purposes, controls and applicable permissions.
PlannedCatalogue scope
Process & cleaning validation support
Defined scope, protocols, acceptance criteria and evidence packages.
PlannedCatalogue scope
Quality & technical agreements
Responsibilities, information exchange and decision boundaries for a proposed arrangement.
PlannedCatalogue scope
Regulatory & documentation support6 planning entries · all Planned
Regulatory & documentation support
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Regulatory dossier support
Product-specific document structures and evidence requirements.
PlannedCatalogue scope
Manufacturing & quality documentation
Controlled technical records for the intended manufacturing scope.
PlannedCatalogue scope
Registration data packages
Assembly and review of evidence for a defined product and destination.
PlannedCatalogue scope
Lifecycle & variation support
Change-related documentation and the applicable product pathways.
PlannedCatalogue scope
Inspection & audit preparation
Evidence organisation and readiness questions; no certification outcome is implied.
PlannedCatalogue scope
Post-market quality & safety interfaces
Future responsibilities for complaints, defects and safety information.
PlannedCatalogue scope
Materials, logistics & supply support6 planning entries · all Planned
Materials, logistics & supply support
Scope for technical discussion. Listing these entries does not establish installed equipment, accepted work or service availability.
Material sourcing & supplier assessment
Material identity, traceability and proposed supplier-evidence requirements.
PlannedCatalogue scope
Qualified storage & warehousing
Storage conditions, status segregation and supporting system evidence.
PlannedCatalogue scope
Cold-chain & distribution planning
Product-specific temperature, route and handling requirements.
PlannedCatalogue scope
Clinical supply packaging & logistics
Study-specific packaging, identification and distribution scope.
PlannedCatalogue scope
Import / export documentation support
Destination, product and responsible-party documentation requirements.
PlannedCatalogue scope
Returns, recalls & disposal coordination
Future lifecycle responsibilities and appropriate controls.
PlannedCatalogue scope
03 · Scoping process
How a catalogue question is scoped.
- 01 · Define
Product & purpose
Identify the product, presentation, development stage and destination.
- 02 · Scope
Technical fit
Compare the question with the planned modules and the catalogue entry.
- 03 · Evidence
Readiness questions
Name the documents, systems and permissions the activity would require.
- 04 · Decide
Next step
Agree whether a technical discussion, a due-diligence request or no further step fits.
Generic process context
This sequence describes how a scoping discussion is structured. It is not an operating procedure and does not represent installed equipment.
04 · Boundaries
A catalogue line is not a service offer.
Project milestones and service availability are different subjects. The facility roadmap gives indicative project quarters; no individual service inherits a date from it.
| Subject | What the catalogue records | What remains separate |
|---|---|---|
| Service entry | A planned service interest with its basis label | Installed equipment, qualification and availability |
| Initial project scope | A line documented in the 15 June 2026 plan | Commissioning, validation and authorisation |
| Catalogue scope | A proposed expansion for technical discussion | Scope confirmation for the product, process, site and jurisdiction |
| Facility roadmap | Indicative project quarters | Any service launch date or supply commitment |
Professional enquiries
Discuss a planned capability.
Name the product or presentation, the service family, the development stage and the destination. A technical discussion does not establish service availability or supply.