Bilthoven Biologicals Drug Substance and Drug Product Facilities

Bilthoven Biologicals Drug Substance and Drug Product Facilities

Multi-product GMP facilities for Drug Substance and Drug Product

About the plant

EU-based GMP manufacturing DS/DP facilities for biologics

1. Drug Substance: multi-purpose, single-use facility for (viral vector) vaccines and biologics, capability for adherent and suspension , cell culture (2x trains), USP with 3x 2,000L scale SUBs and DSP (2x trains) with single-use technology
2. Drug Product: multi-purpose filling line for syringes and vials

These are new state-of-the-art facilities with much flexibility for viral vector, vaccines and other biologicals, fully supported by QA/QC/QP

As a strategic partner to BBio, the following benefits are available

• Access to fully operational GMP facilities for DS and DP in EU
• Flexibility to manufacture clinical and commercial material in EU
• Support with QA/QC/QP infrastructure of BBio for release of clinical and commercial material
• Lease GMP facilities with GMP trained staff, without substantial CAPEX investment required to establish GMP certified infrastructure
• A long-term strategic collaboration, with GMP manufacturing infrastructure in EU ensured

 

 

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Compliance

• EMA (EU GMP)

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Activity

• Cell therapy derivatives / Secretomes, Vaccines, Injectables, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, BIOLOGICS, SERVICES manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): N/A
• Controlled substance: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets: EMA (EU), MHRA (UK)

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Batch Size / Reactor

• Small, Medium, Large, Batch, 2000 - 5000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Clean room rental, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, Drug Product – Liquid

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