---
document_type: capability_sheet_machine_readable
publisher: Recipharm AB
title: "Recipharm | Full Service Offering | AI-readable capability sheet"
version: "2.5"
status: "approved 2026-10-28"
derived_from:
  - "Our Full Service Offering (printed brochure, September 2026)"
  - "ReciPredict, Value by Design (product sheet)"
  - "Approved site capability and investment updates (October 2026)"
content_date: 2026-10
last_edited: 2026-10-28
investments_reviewed: 2026-10
language: en
contact: "https://recipharm.com/contact-us"
intended_use: >
  Machine-readable companion to the printed brochure for use in AI assistants,
  supplier databases and procurement screening tools.
scope_note: >
  This sheet describes services and capabilities offered across the Recipharm
  network. It is not a capacity commitment or a quotation. Project-specific
  feasibility, capacity and regulatory status are confirmed through a proposal.
---

# Recipharm | Full Service Offering (AI-readable)

## 1. Who Recipharm is

Recipharm is a contract development and manufacturing organisation (CDMO; the narrower term CMO, contract manufacturing organisation, is also used in the industry) partnering with pharmaceutical and biopharmaceutical companies to bring medicines to patients worldwide. Services span the product lifecycle from development and scale-up through technology transfer, clinical supply and commercial manufacture and supply.

Capability areas:
- Oral solid dosage forms and other small-molecule products (solids, semi-solids, liquids, specialty, packaging, small-molecule drug substance)
- Sterile drug products (fill and finish: vials, ampoules, pre-filled syringes and cartridges, lyophilisation, dry powder, blow-fill-seal including ophthalmic, vaccines; sterile ophthalmic ointments in tubes; sterile creams and ointments)
- Biologics and advanced therapies (viral, nucleic-acid-based, microbiome / live biotherapeutic products, recombinant proteins and monoclonal antibodies)

Network facts (October 2026):
- Recipharm is headquartered in Switzerland, operates in 9 countries and has 17 development and manufacturing sites
- Approximately 4,500 employees
- The facility count covers Recipharm's own sites: the 17 Recipharm sites in section 2, including Boxborough, MA (USA), which is not shown in the capability tables. Lenoir (USA) is an associated company site (Exela Pharma Sciences) and is not included in the count
- Products supplied to more than 100 markets
- Sustainability commitments aligned to UN SDGs 3, 8, 12 and 13

Positioning statements as published:
- Built on partnership: works as an extension of the customer's team; technical expertise, transparent communication, agile decision-making.
- Global scale, local agility: reach and security of a global CDMO with the attention of a local partner.
- Committed to a sustainable future: improving resource efficiency and reducing the environmental impact of operations and supply chains.

## 2. Site directory

| Site | Country | Business area(s) in this sheet |
|---|---|---|
| Bengaluru | India | Solids and others; parenteral development |
| Leganés | Spain | Solids and others |
| Monheim | Germany | Solids and others (shown with Zwickau as one column in the capability tables) |
| Zwickau | Germany | Solids and others (shown with Monheim as one column in the capability tables) |
| Paderno Dugnano | Italy | Solids and others (small-molecule drug substance) |
| Pianezza | Italy | Solids and others (liquids, packaging) |
| Queluz (Lisbon) | Portugal | Solids and others (non-sterile) (shown with Odivelas as one column in the capability tables) |
| Odivelas (Lisbon) | Portugal | Sterile delivery only (sterile ophthalmic ointments in tubes; new line for sterile creams and ointments) (shown with Queluz as one column in the capability tables) |
| Uppsala | Sweden | Solids and others |
| Kaysersberg | France | Sterile delivery (blow-fill-seal, from pilot and clinical scale to commercial) |
| Wasserburg | Germany | Sterile delivery |
| Masate | Italy | Sterile delivery |
| Brescia | Italy | Sterile delivery (dry powder, beta-lactam antibiotics) |
| Cuxhaven | Germany | Advanced biologics; sterile delivery (vials) |
| Oeiras | Portugal | Advanced biologics |
| Watertown, MA | USA | Advanced biologics; sterile delivery (vials); preclinical to commercial programmes |
| Boxborough, MA | USA | Facility offered for customer-specific fit-out on a dedicated-capacity basis; not shown in the capability tables |

Associated companies: New Biologix, gene therapy, Switzerland; Exela Pharma Sciences, sterile manufacturing, USA.

### 2.1 Site summaries

One line per site, derived from the capability tables in sections 3 to 5 (the tables are authoritative; these lines carry the same content for readers that handle lists better than wide tables). (M) = manufacturing, (D) = development, (M+D) = both; biologics services are grouped by modality and stage.

- **Bengaluru, India**. Oral solid dosage and non-sterile: Tablets (M+D); Effervescent tablets (M+D); Capsules (M+D); Coated pellets (D); Granules, powders (M+D); Non-antibiotic beta-lactam (M); Controlled drugs (M+D); Analytical specialty lab (D); Blisters (M+D); Bottles, jars (M+D); Tubes (D); Sachets (D). Sterile fill and finish: Parenteral development (D). Licences and standards: FDA (US); EU GMP; PMDA (Japan); ISO 9001; ISO 13485 (oral care products only); ISO 14001; ISO 45001 / OHSAS 18001.
- **Leganés, Spain**. Oral solid dosage and non-sterile: Tablets (M); Capsules (M); Granules, powders (M); High potency (M+D); Controlled drugs (M); Blisters (M); Bottles, jars (M). Licences and standards: FDA (US); EU GMP; PMDA (Japan); Clinical trial material (IMP); ISO 14001; ISO 45001 / OHSAS 18001. Containment: OEB 5 (OEL <1 µg/m³).
- **Monheim and Zwickau, Germany** (two separate sites, reported together). Oral solid dosage and non-sterile: Tablets (M+D); Capsules (M+D); Coated pellets (M); Granules, powders (M+D); Controlled drugs (M); Blisters (M); Secondary pack, pre-filled syringes (M). Licences and standards: FDA (US); EU GMP; PMDA (Japan); ISO 14001; ISO 45001 / OHSAS 18001. Containment: OEB 4 for processes with a dilution step immediately after dispensing (API concentration reduced); OEB 3 otherwise.
- **Paderno Dugnano, Italy**. Oral solid dosage and non-sterile: Small molecule (API) (M+D); Tablets (M); Capsules (M). Licences and standards: FDA (US); EU GMP; PMDA (Japan); Clinical trial material (IMP); Veterinary products; ISO 14001; ISO 45001 / OHSAS 18001.
- **Pianezza, Italy**. Oral solid dosage and non-sterile: Sprays (M, on request: line reinstatement required, approx. 12 to 15 months to PPQ); Liquids (M); Controlled drugs (M); Blisters (M). Licences and standards: FDA (US), veterinary products only; EU GMP; Veterinary products; ISO 14001.
- **Queluz and Odivelas, Portugal** (two separate sites, reported together). Oral solid dosage and non-sterile: Tablets (M); Effervescent tablets (M); Capsules (M); Granules, powders (M); Suppositories (M); Gels, ointments, creams (M); Sprays (M); Suspensions, emulsions (M); Liquids (M); Controlled drugs (M); Blisters (M); Bottles, jars (M); Tubes (M); Sachets (M). Sterile fill and finish: Sterile ophthalmic ointments, tubes (M). Licences and standards (solids and others, Queluz): FDA (US); EU GMP; PMDA (Japan); Clinical trial material (IMP); Veterinary products; ISO 14001; ISO 45001 / OHSAS 18001. Licences and standards (sterile delivery, Odivelas): EU GMP. Containment: OEB 4. Non-sterile capabilities are offered at Queluz; sterile capabilities are offered at Odivelas, which is sterile only. FDA (US) and PMDA (Japan) listings apply to Queluz only. Recent and planned investments (new line for sterile creams and ointments in tubes at Odivelas): see section 6.
- **Uppsala, Sweden**. Oral solid dosage and non-sterile: Tablets (M); Suppositories (M). Licences and standards: FDA (US); EU GMP; PMDA (Japan); Clinical trial material (IMP); ISO 14001; ISO 45001 / OHSAS 18001.
- **Kaysersberg, France**. Sterile fill and finish: Vaccines (M); Blow-fill-seal (M+D); Terminal or bulk sterilisation (M). Inspection and packaging: Manual inspection (manual visual inspection as part of in-process controls); Labelling; Pouching; Packaging incl. serialisation. Licences and standards: FDA (US); EU GMP; PMDA (Japan); Clinical trial material (IMP); ISO 13485; ISO 14001; ISO 45001 / OHSAS 18001. Containment: BSL-1 compounding and filling; BSL-2 microbiology laboratory. Blow-fill-seal scales, formats and batch sizes, including the LAB+ small-scale system for development and clinical batches: see section 4.4. Recent and planned investments (new ophthalmic blow-fill-seal line): see section 6.
- **Wasserburg, Germany**. Sterile fill and finish: Vials (M+D); Pre-filled syringes / cartridges (M+D); Lyophilisation in vials (M); Vaccines (M); Terminal or bulk sterilisation (M). Inspection and packaging: Manual; Semi-automatic; Automatic; Labelling; Packaging incl. serialisation. Licences and standards: FDA (US); EU GMP; PMDA (Japan); Clinical trial material (IMP); ISO 14001; ISO 45001 / OHSAS 18001. Containment: OEB 4 (liquid vials); OEB 3 (lyophilised vials); BSL-1 compounding and filling. Recent and planned investments (Line 8 liquid vial bypass; Line 11 pre-filled syringe module; automated visual inspection for pre-filled syringes): see section 6.
- **Masate, Italy**. Sterile fill and finish: Vials (M); Ampoules (M); Lyophilisation in vials (M); Terminal or bulk sterilisation (M). Inspection and packaging: Manual; Semi-automatic; Automatic; Labelling; Packaging incl. serialisation. Licences and standards: EU GMP; Clinical trial material (IMP); ISO 14001; ISO 45001 / OHSAS 18001. Containment: BSL-1 compounding and filling. Recent and planned investments (new liquid vial filling line; planned FDA inspection): see section 6.
- **Brescia, Italy**. Sterile fill and finish: Vials (M); Ampoules (M); Dry powder fill (M); Beta-lactam antibiotics (penicillins, cephalosporins) (M); Terminal or bulk sterilisation (M). Inspection and packaging: Manual inspection (manual inspection for low batch sizes); Automatic inspection; Labelling; Packaging incl. serialisation. Licences and standards: FDA (US); EU GMP; Clinical trial material (IMP); Veterinary products; ISO 14001; ISO 45001 / OHSAS 18001. Containment: BSL-1 compounding and filling.
- **Cuxhaven, Germany**. Sterile fill and finish: Vials (M+D); Vaccines (M+D). Inspection and packaging: Manual; Semi-automatic; Labelling. Viral: Raw and starting materials: Pre-MVSS rescue from plasmid (development service (Process Development), not a stand-alone GMP service); Experience with customer-licensed cell lines; Cell bank production (MCB/WCB); Master virus seed production (MVSS/WVSS) | Development: Process development (USP, DSP, formulation); Analytical method establishment (IPC, QC lot release) | Manufacture, fill and finish: Drug substance (non-GMP / GMP); Avian-based production (eggs, chick-embryo fibroblasts); Cell culture-based production (primary, continuous cell lines); Drug product (non-GMP / GMP); Sterile fill and finish (liquid) | Quality control, release and stability: In-process control, drug substance and drug product testing; Quality control lot release testing; Control cell generation (as part of GMP seed and drug substance production where the pharmacopoeia requires it; not a stand-alone service); Assay qualification and validation; Stability studies. Microbiome / live biotherapeutic products (non-spore-forming bacterial strains only): Raw and starting materials: Cell bank production (MCB/WCB) | Development: Process (USP, DSP, formulation); Analytical assays; Analytical method transfer and development | Manufacture, fill and finish: Drug substance (non-GMP / GMP); Drug product (non-GMP / GMP); Drug product format: vials | Quality control, release and stability: In-process control, drug substance and drug product testing; Quality control release testing; Assay qualification and validation; Stability studies. Licences and standards: EU GMP; Clinical trial material (IMP). Containment: BSL-2 facility, GMO-ready. Recent and planned investments (new isolator fill and finish line for liquid and lyophilised biologics): see section 6.
- **Oeiras, Portugal**. Viral: Raw and starting materials: Plasmid DNA production; Pre-MVSS rescue from plasmid; Experience with customer-licensed cell lines; Cell bank production (MCB/WCB); Master virus seed production (MVSS/WVSS) | Development: Process development (USP, DSP, formulation); Analytical method establishment (IPC, QC lot release) | Manufacture, fill and finish: Drug substance (non-GMP / GMP); Cell culture-based production (primary, continuous cell lines); Drug product (non-GMP / GMP); Sterile fill and finish (liquid) | Quality control, release and stability: In-process control, drug substance and drug product testing; Quality control lot release testing; Control cell generation; Assay qualification and validation; Stability studies. Nucleic-acid-based: Raw and starting materials: Plasmid DNA production | Development: Process (IVT, DNA digestion, RNA purification); Analytical assays | Manufacture, fill and finish: Fermentation and plasmid expansion; Plasmid linearisation, transcription, capping, tailing; Drug product (non-GMP / GMP), vials | Quality control, release and stability: In-process control sample testing; Quality control release testing; Assay qualification and validation; Stability studies. Microbiome / live biotherapeutic products: Raw and starting materials: Strain selection; Colony isolation; Cell bank production (MCB/WCB) | Development: Process (USP, DSP, formulation); Analytical assays; Analytical method transfer and development | Manufacture, fill and finish: Drug substance (non-GMP / GMP); Drug product (non-GMP / GMP); Drug product format: vials | Quality control, release and stability: In-process control, drug substance and drug product testing; Quality control release testing; Assay qualification and validation; Stability studies. Recombinant proteins and monoclonal antibodies (mAbs): suspension culture in stirred-tank bioreactors up to 200 L (XDR50, Biostat STR 50 and 200, RM 25, shake flasks); adherent culture (roller bottles, cell stacks); experience with mammalian, avian and insect cell lines (CHO, CAP, Vero, EB66, HEK293, A549, HeLa, S2, Sf9). Programme support: clinical and commercial supply, depending on product and volume. Licences and standards: EU GMP; FDA registered (last FDA inspection 2025). Recent and planned investments (500 L bioreactor): see section 6.
- **Watertown, USA**. Sterile fill and finish: Vials (M); Vaccines (M; nucleic-acid (mRNA) based vaccines; no viral vaccine drug substance at Watertown). Inspection and packaging: Manual. Viral: Raw and starting materials: Plasmid DNA production. Nucleic-acid-based: Raw and starting materials: Plasmid cloning; Plasmid DNA production | Development: Process (IVT, DNA digestion, RNA purification); Analytical assays; mRNA encapsulation | Manufacture, fill and finish: Fermentation and plasmid expansion; Plasmid linearisation, transcription, capping, tailing; mRNA encapsulation (lipid nanoparticle formulation); Drug product (non-GMP / GMP), vials | Quality control, release and stability: In-process control sample testing; Quality control release testing; Assay qualification and validation; Stability studies. Licences and standards: Clinical trial material (IMP). Programme support: preclinical, clinical (phase I to III) and commercial. Containment: BSL-2 facility.

Legend used in all capability tables below:
- Monheim and Zwickau are two separate sites, as are Queluz and Odivelas; each pair shares one column in the tables. A value in a shared column means the capability is offered at one or both of the two sites; for Monheim/Zwickau, which site applies is confirmed through Recipharm. For Queluz/Odivelas, non-sterile capabilities (section 3) are offered at Queluz and sterile capabilities (section 4) at Odivelas, which is sterile only; FDA (US) and PMDA (Japan) listings apply to Queluz only
- `M` = manufacturing offered at this site
- `D` = development offered at this site
- `M+D` = both
- empty cell = not listed for this site (not a statement of absence)

## 3. Solids and others (oral solid dosage, OSD; non-sterile liquids and semi-solids; small-molecule drug substance)

Sites (columns): Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala

### 3.1 Drug substance

| Capability | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| Small molecule (API) | | | | M+D | | | |

### 3.2 Solids

| Capability | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| Tablets | M+D | M | M+D | M | | M | M |
| Effervescent tablets | M+D | | | | | M | |
| Capsules | M+D | M | M+D | M | | M | |
| Coated pellets | D | | M | | | | |
| Granules, powders | M+D | M | M+D | | | M | |

### 3.3 Semi-solids

| Capability | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| Suppositories | | | | | | M | M |
| Gels, ointments, creams | | | | | | M | |

### 3.4 Liquids

| Capability | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| Sprays | | | | | M (on request, see note) | M | |
| Suspensions, emulsions | | | | | | M | |
| Liquids | | | | | M | M | |

Note, Pianezza sprays: spray filling (nasal, throat, ear) is available on request; line reinstatement required, approx. 12 to 15 months to PPQ.

### 3.5 Specialty

| Capability | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| High potency | | M+D | | | | | |
| High-potency containment level | | OEB 5 (OEL <1 µg/m³) | OEB 4 for processes with a dilution step immediately after dispensing (API concentration reduced); OEB 3 otherwise | | | OEB 4 | |
| Non-antibiotic beta-lactam | M | | | | | | |
| Controlled drugs | M+D | M | M | | M | M | |
| Analytical specialty lab | D | | | | | | |

### 3.6 Packaging

| Capability | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| Blisters | M+D | M | M | | M | M | |
| Bottles, jars | M+D | M | | | | M | |
| Tubes | D | | | | | M | |
| Sachets | D | | | | | M | |
| Secondary pack, pre-filled syringes | | | M | | | | |

### 3.7 GMP licences and ISO (solids and others)

| Licence / standard | Bengaluru | Leganés | Monheim/Zwickau | Paderno Dugnano | Pianezza | Queluz/Odivelas | Uppsala |
|---|---|---|---|---|---|---|---|
| FDA (US) | yes | yes | yes | yes | yes (veterinary products only) | yes | yes |
| EU GMP | yes | yes | yes | yes | yes | yes | yes |
| PMDA (Japan) | yes | yes | yes | yes | | yes | yes |
| Clinical trial material (IMP) | | yes | | yes | | yes | yes |
| Veterinary products | | | | yes | yes | yes | |
| ISO 13485 | yes (oral care products only) | | | | | | |
| ISO 14001 | yes | yes | yes | yes | yes | yes | yes |
| ISO 45001 / OHSAS 18001 | yes | yes | yes | yes | | yes | yes |

## 4. Sterile delivery (sterile fill and finish, aseptic filling, injectables)

Sites (columns): Bengaluru | Brescia | Cuxhaven | Kaysersberg | Masate | Queluz/Odivelas | Wasserburg | Watertown. In the Queluz/Odivelas column, sterile capabilities are offered at Odivelas.

### 4.1 Fill and finish

| Capability | Bengaluru | Brescia | Cuxhaven | Kaysersberg | Masate | Queluz/Odivelas | Wasserburg | Watertown |
|---|---|---|---|---|---|---|---|---|
| Vials | | M | M+D | | M | | M+D | M |
| Ampoules | | M | | | M | | | |
| Pre-filled syringes / cartridges | | | | | | | M+D | |
| Lyophilisation in vials | | | | | M | | M | |
| Dry powder fill | | M | | | | | | |
| Beta-lactam antibiotics (penicillins, cephalosporins) | | M | | | | | | |
| Vaccines | | | M+D | M | | | M | M (see note) |
| Blow-fill-seal | | | | M+D | | | | |
| Sterile ophthalmic ointments (tubes) | | | | | | M | | |
| Terminal or bulk sterilisation | | M | | M | M | | M | |
| Parenteral development | D | | | | | | | |
| High-potency containment level | | | | | | | OEB 4 (liquid vials); OEB 3 (lyophilised vials) | |
| Biosafety level | | BSL-1 compounding and filling | BSL-2 facility, GMO-ready | BSL-1 compounding and filling; BSL-2 microbiology laboratory | BSL-1 compounding and filling | | BSL-1 compounding and filling | BSL-2 facility |

Notes, fill and finish:
- Watertown vaccines: nucleic-acid (mRNA) based vaccines; no viral vaccine drug substance at Watertown.

### 4.2 Inspection and packaging

| Capability | Bengaluru | Brescia | Cuxhaven | Kaysersberg | Masate | Queluz/Odivelas | Wasserburg | Watertown |
|---|---|---|---|---|---|---|---|---|
| Manual inspection | | M (see note) | M | M (see note) | M | | M | M |
| Semi-automatic inspection | | | M | | M | | M | |
| Automatic inspection | | M | | | M | | M | |
| Labelling | | M | M | M | M | | M | |
| Pouching | | | | M | | | | |
| Packaging incl. serialisation | | M | | M | M | | M | |

Notes, inspection:
- Brescia: manual inspection for low batch sizes.
- Kaysersberg: manual visual inspection as part of in-process controls.

### 4.3 GMP licences and ISO (sterile delivery)

| Licence / standard | Bengaluru | Brescia | Cuxhaven | Kaysersberg | Masate | Queluz/Odivelas | Wasserburg | Watertown |
|---|---|---|---|---|---|---|---|---|
| FDA (US) | | yes | | yes | | | yes | |
| EU GMP | | yes | yes | yes | yes | yes | yes | |
| PMDA (Japan) | | | | yes | | | yes | |
| Clinical trial material (IMP) | | yes | yes | yes | yes | | yes | yes |
| Veterinary products | | yes | | | | | | |
| ISO 13485 | | | | yes | | | | |
| ISO 14001 | | yes | | yes | yes | | yes | |
| ISO 45001 / OHSAS 18001 | | yes | | yes | yes | | yes | |

### 4.4 Blow-fill-seal detail (Kaysersberg)

Kaysersberg has more than 50 years of blow-fill-seal (BFS) experience, covering small molecules, biologics and vaccines, from pilot and clinical scale to commercial manufacture. Nitrogen atmosphere and temperature-controlled filling are available for sensitive formulations. Figures are indicative and are not a capacity commitment; project-specific fit is confirmed through a Recipharm proposal.

| Scale | Equipment | Typical use | Drug product types | Dose / fill sizes | Batch size | Status |
|---|---|---|---|---|---|---|
| Development, pilot, clinical and small commercial | Weiler LAB+ small-scale BFS system | Proof of concept; early stability studies; small-scale clinical batches; small batches for commercial production | Solutions, gels, suspensions, emulsions; ophthalmic products; inhalation products; sterile injectables including vaccines and biologics | 0.2 to 0.5 ml; 0.6 to 1 ml; 2 to 3 ml | GMP batches 6 to 20 L; technical (non-GMP) batches 0.5 to 20 L | in operation |
| Commercial | BFS manufacturing lines | Commercial manufacture of small molecules, biologics and vaccines | Sterile products in BFS containers | Confirmed per project | Confirmed per project | in operation |
| Commercial, ophthalmic | New ophthalmic BFS line | Commercial ophthalmic supply: launch, growth, second source, move from glass to plastic containers | Ophthalmic products | 0.4 to 1 ml doses | Confirmed per project | capacity open for booking (see section 6) |

LAB+ system details:
- Container polymers: low-density polyethylene (LDPE) grades meeting USP chapter 661.1 (extractable metals and plastic additives) and USP chapter 87 (biological reactivity); other polymer types such as polypropylene (PP) can be used
- Dosage designs: single-dose; multi-dose; Luer-lock neck compatible for use with drug delivery devices such as inhalers, auto-injectors or syringes
- Formulation charging: conventional multi-use charge bottles or single-use charge bags, to simplify technology transfer
- Environmental controls: sterile fill and finish under cleanroom conditions suited to ophthalmic and injectable formulations and to sensitive large-molecule formulations; nitrogen filling atmosphere for biologic products; temperature-controlled environment

## 5. Advanced biologics (viral products, plasmid DNA, mRNA including lipid nanoparticle formulation, microbiome and live biotherapeutic products, recombinant proteins and monoclonal antibodies)

Sites (columns): Cuxhaven (Germany) | Oeiras (Portugal) | Watertown, MA (USA). All three operate BSL-2 facilities. In these tables `yes` = service offered at the site.

### 5.1 Viral

| Stage | Service | Cuxhaven | Oeiras | Watertown |
|---|---|---|---|---|
| Raw and starting materials | Plasmid DNA production | | yes | yes |
| Raw and starting materials | Pre-MVSS rescue from plasmid | yes (see note) | yes | |
| Raw and starting materials | Experience with customer-licensed cell lines | yes | yes | |
| Raw and starting materials | Cell bank production (MCB/WCB) | yes | yes | |
| Raw and starting materials | Master virus seed production (MVSS/WVSS) | yes | yes | |
| Development | Process development (USP, DSP, formulation) | yes | yes | |
| Development | Analytical method establishment (IPC, QC lot release) | yes | yes | |
| Manufacture, fill and finish | Drug substance (non-GMP / GMP) | yes | yes | |
| Manufacture, fill and finish | Avian-based production (eggs, chick-embryo fibroblasts) | yes | | |
| Manufacture, fill and finish | Cell culture-based production (primary, continuous cell lines) | yes | yes | |
| Manufacture, fill and finish | Drug product (non-GMP / GMP) | yes | yes | |
| Manufacture, fill and finish | Sterile fill and finish (liquid) | yes | yes | |
| Quality control, release and stability | In-process control, drug substance and drug product testing | yes | yes | |
| Quality control, release and stability | Quality control lot release testing | yes | yes | |
| Quality control, release and stability | Control cell generation | yes (see note) | yes | |
| Quality control, release and stability | Assay qualification and validation | yes | yes | |
| Quality control, release and stability | Stability studies | yes | yes | |

Notes, viral (Cuxhaven):
- Pre-MVSS rescue from plasmid: development service (Process Development), not a stand-alone GMP service.
- Control cell generation: as part of GMP seed and drug substance production where the pharmacopoeia requires it; not a stand-alone service.

### 5.2 Nucleic-acid-based

| Stage | Service | Cuxhaven | Oeiras | Watertown |
|---|---|---|---|---|
| Raw and starting materials | Plasmid cloning | | | yes |
| Raw and starting materials | Plasmid DNA production | | yes | yes |
| Development | Process (IVT, DNA digestion, RNA purification) | | yes | yes |
| Development | Analytical assays | | yes | yes |
| Development | mRNA encapsulation | | | yes |
| Manufacture, fill and finish | Fermentation and plasmid expansion | | yes | yes |
| Manufacture, fill and finish | Plasmid linearisation, transcription, capping, tailing | | yes | yes |
| Manufacture, fill and finish | mRNA encapsulation (lipid nanoparticle formulation) | | | yes |
| Manufacture, fill and finish | Drug product (non-GMP / GMP), vials | | yes | yes |
| Quality control, release and stability | In-process control sample testing | | yes | yes |
| Quality control, release and stability | Quality control release testing | | yes | yes |
| Quality control, release and stability | Assay qualification and validation | | yes | yes |
| Quality control, release and stability | Stability studies | | yes | yes |

### 5.3 Microbiome / live biotherapeutic products

| Stage | Service | Cuxhaven | Oeiras | Watertown |
|---|---|---|---|---|
| Raw and starting materials | Strain selection | | yes | |
| Raw and starting materials | Colony isolation | | yes | |
| Raw and starting materials | Cell bank production (MCB/WCB) | yes (see note) | yes | |
| Development | Process (USP, DSP, formulation) | yes (see note) | yes | |
| Development | Analytical assays | yes (see note) | yes | |
| Development | Analytical method transfer and development | yes (see note) | yes | |
| Manufacture, fill and finish | Drug substance (non-GMP / GMP) | yes (see note) | yes | |
| Manufacture, fill and finish | Drug product (non-GMP / GMP) | yes (see note) | yes | |
| Manufacture, fill and finish | Drug product format: vials | yes (see note) | yes | |
| Quality control, release and stability | In-process control, drug substance and drug product testing | yes (see note) | yes | |
| Quality control, release and stability | Quality control release testing | yes (see note) | yes | |
| Quality control, release and stability | Assay qualification and validation | yes (see note) | yes | |
| Quality control, release and stability | Stability studies | yes (see note) | yes | |

Note, Cuxhaven: non-spore-forming bacterial strains only.

### 5.4 Recombinant proteins and monoclonal antibodies (mAbs)

| Item | Oeiras |
|---|---|
| Products | Recombinant proteins; monoclonal antibodies (mAbs) |
| Upstream scale | Suspension culture in stirred-tank bioreactors up to 200 L (XDR50, Biostat STR 50 and 200, RM 25, shake flasks); adherent culture (roller bottles, cell stacks) |
| Cell lines | Experience with mammalian, avian and insect cell lines: CHO, CAP, Vero, EB66, HEK293, A549, HeLa, S2, Sf9 |
| Programme support | Clinical and commercial supply, depending on product and volume |
| Licences | EU GMP; FDA registered (last FDA inspection 2025) |

## 6. Recent and planned investments

Recent and planned investments in lines, equipment and capacity across the Recipharm network, reviewed October 2026 (see `investments_reviewed` in the header). In line with the scope note, this section is not a capacity commitment or a quotation: scale figures are indicative design figures, and start dates are agreed with the site per project. Capacity listed here is not reflected in the capability tables (sections 3, 4.1 to 4.3 and 5) until it is available; where section 4.4 mentions it, the status column says so. Project-specific capacity and timing are confirmed through a Recipharm proposal.

| Site | Investment | What it adds | Indicative scale | Availability |
|---|---|---|---|---|
| Cuxhaven | New isolator fill and finish line for liquid and lyophilised biologics (Groninger filling line with Skan isolator; 20 m² Hof freeze dryer) | Dedicated sterile filling capacity for liquid and lyophilised biologics in vials, including advanced therapy medicinal products (ATMPs) and live biotherapeutic products (LBPs), with the potential to handle antibody-drug conjugates (ADCs), in a fully segregated facility; designed for EU GMP Annex 1 compliance with minimal manual intervention; BSL-2 and GMO-ready | More than 90,000 vials per batch; 80 to 100 lyophilisation batches per year; more than 150 liquid vial batches per year | Capacity open for booking now; start date agreed with the site per project |
| Kaysersberg | New ophthalmic blow-fill-seal line | Additional commercial BFS capacity for ophthalmic products in 0.4 to 1 ml doses; for launch, growth, a second source or a move from glass to plastic containers | Approximately 185 million doses per year | Capacity open for booking now; start date agreed with the site per project |
| Masate | New liquid vial filling line | Liquid vial filling in a Grade A environment (active C-RABS or isolator, Grade B background); aseptic filling and terminal sterilisation on the same line | Up to 15,000 vials per hour (2 mL vials); 2R to 20R vials | Target 2029, after regulatory approval of the new department; capacity open for booking now |
| Masate | Planned FDA inspection | Preparation for supply to the US market | | FDA inspection planned for 2027 |
| Odivelas | New sterile creams and ointments line | Sterile creams and ointments in aluminium or polyfoil tubes; the line will be EU GMP Annex 1 compliant; flexible batch sizes and fill volumes | Tube fill sizes 3.5 to 30 g; 8 to 15 million units per year, depending on batch size and fill volume | Capacity open for booking now; start date agreed with the site per project |
| Oeiras | 500 L bioreactor | Additional suspension culture capacity for virus, protein and mAbs | 500 L | 500 L bioreactor available; capacity open for booking now; start date agreed with the site per project |
| Wasserburg | Line 8 liquid vial bypass | Automated liquid vial filling on the existing Line 8 Groninger filler, alongside lyophilised vials on the same line and quality system; hybrid isolator/RABS containment; piston and peristaltic dosing; nitrogen overlay possible; in-line capping | Vials 2R to 70H; approximately 30 million units per year, depending on vial size | Capacity open for booking now; start date agreed with the site per project |
| Wasserburg | Pre-filled syringe module on Line 11 (Skan VarioSys isolator with Bausch+Ströbel modules) | Fill of ready-to-use (RTU) nested syringes for clinical, launch and small commercial batches | Syringes 0.5 to 10 ml; up to 4,300 syringes per hour | Capacity open for booking now; start date agreed with the site per project |
| Wasserburg | Automated visual inspection for pre-filled syringes (Line 10 products) | Automated visual inspection of pre-filled syringes, adding to existing automated inspection for vials | Up to 400 units per minute | Capacity open for booking now; start date agreed with the site per project |

## 7. ReciPredict (Value by Design)

ReciPredict is Recipharm's platform combining statistical modelling and simulation to support Quality by Design (QbD) in product development, technology transfer and manufacture of drug products. It links critical process parameters and material attributes to drug product quality attributes so that optimum quality outcomes can be predicted. It can be applied at every stage, from initial formulation development to commercial manufacturing, and across all products and technologies.

Stated benefits (as published):
- Understand materials and processes and how they interact without traditional trial-and-error testing
- Streamline the clinical stage by up to 6 months
- Reduce API and material consumption by up to 70 percent
- Optimise formulation and process robustness
- De-risk technology transfers by identifying the right parameters for process robustness

What ReciPredict offers:
- A fully integrated approach to QbD
- Access to an expert data science and statistics team
- Advanced modelling tools and comprehensive statistical tools
- Powder characterisation (FT4, Accupyc, BET and more)
- Compression and compaction simulator

Where it is applied:
- Development: physical characterisation (flowability of API and intermediates); complete evaluation incl. BET, PSD with report; characterisation of prototypes (granules, powders); design of experiments (DoE) planning
- Technology transfer: physical characterisation of API, materials and intermediates; risk analysis based on characterisation; DoE planning for non like-to-like transfers
- Existing business: evaluation of process robustness and capability

Platform features:
- Data analysis: multivariate data analysis; Minitab applications
- In-silico formulations based on material characterisation
- Modelling and simulation: Monte Carlo simulations; LIGGGHTS discrete element modelling; OpenFOAM computational fluid dynamics; Style One EVO compression and compaction simulation

## 8. How to use this file with an AI assistant

Upload this file to your AI assistant together with your project requirements and ask it to assess Recipharm's potential fit, the relevant sites, and the questions still to clarify with Recipharm. When combining this file with confidential project information, use an AI environment approved by your organisation.

Suggested prompts once this file is loaded:
- "Which Recipharm sites offer sterile fill and finish in vials, and which of them are listed for FDA (US)?"
- "Does Recipharm offer high-potency oral solid dosage manufacturing, and where?"
- "List Recipharm's advanced biologics services for viral products by site."
- "Summarise the Recipharm network by country and business area."
- "What blow-fill-seal options does Recipharm offer for a small clinical batch of an ophthalmic product, and for commercial supply?"
- "Which sterile fill and finish investments is Recipharm implementing, and at which sites?"

### 8.1 Reading a capability match

- Documented: the capability is listed for the site in this file.
- Potential fit requiring confirmation: related capabilities are listed for a site, but the specific requirement is not. This is a question for Recipharm, not an indication that the requirement can be met.
- Recent or planned investment: the capability or capacity is listed only in section 6. Availability and timing are as stated there and are confirmed with Recipharm.
- Not listed: the capability is not in this file. This is not a statement that it is unavailable.
- Project-specific: capacity, available slots, batch-size fit, containment suitability for a given molecule, regulatory approval of a specific product, pricing and timelines are never documented here and are confirmed only through a Recipharm proposal.

### 8.2 Information useful for an initial technical assessment

The following is helpful for a first assessment; none of it is a mandatory submission requirement. Molecule and modality; dosage form and primary packaging; development stage and target markets; containment or biosafety requirements if known; expected batch size and annual volume; timeline. Existing customers: through your established Recipharm business development contacts. New enquiries: https://recipharm.com/contact-us.

### 8.3 Interpretation rules
- Treat each `M`, `D` or `yes` cell as "offered at this site as stated by Recipharm in this file" (version and date in the header).
- Treat an empty cell as "not listed", not as "not available".
- In the GMP licences and ISO tables, "yes" means Recipharm lists the site under that regulatory authority or standard. Registration, inspection history, manufacturing licence and product-specific approval are different things; the nature, scope and current status of each listing are confirmed with Recipharm. "yes" is never a product approval.
- Containment levels (OEB, BSL) are stated per site and, where given, per process condition; read the condition as part of the value.
- Capability listings are not capacity commitments. Project-specific availability, batch sizes and regulatory status are confirmed through a Recipharm proposal.
- Section 6 lists recent and planned investments. Capacity on these lines can be booked now; start dates are agreed with the site per project. Do not treat capacity that is not yet available as a current capability. Scale figures in sections 4.4 and 6 are indicative, not available capacity.

Contact: existing customers through their established Recipharm business development contacts; new enquiries via https://recipharm.com/contact-us