HIPRA BIOTECH SERVICES | Amer

HIPRA BIOTECH SERVICES | Amer

End-to-end internal capabilities from cell line development to commercial manufacturing

About the plant

HIPRA Biotech Services is HIPRA’s CDMO division, bringing over 50 years of scientific and technical excellence to pharmaceutical and biotechnology companies, offering comprehensive contract development and manufacturing services in a wide range of biologics technologies and modalities.

• We have capacity available now to start development, clinical supply and commercial manufacturing projects in mammalian, microbial, and aseptic fill & finish.
• We are able to hit 12 months from Gene/Strain to Drug Substance as demonstrated by BIMERVAX® (which we adapt each year in 4-6 months) and our typical lead times demonstrated in dozens of programs in Animal Health
• We have been EMA approved for almost 30 years with an excellent inspection track record, and we are getting ready for FDA approval by mid-2026

 

Our AIGUAVIVA campus features our R&D labs and our Microbial DS manufacturing expansion.  

Our AMER campus offers our Microbial DS, Mammalian DS, Aseptic F&F, and QC services.

 

DEVELOPMENT (AIGUAVIVA campus)

From early discovery to clinical manufacturing production, we accelerate each stage of biologics drug development with expertise and flexibility.

Our AIGUAVIVA Development labs feature high-throughput bioreactor systems (Ambr®15 and Ambr®250) for design of experiments, small- and mid-scale benchtop bioreactors, Cobas® analyzers (for clinical chemistry and immunochemistry assays), and advanced tools for cell line development, complemented by a specialized area for process development and a dedicated GMP area for early-phase clinical batch production.

MANUFACTURING (AMER and AIGUAVIVA campuses)

We provide robust and flexible pharmaceutical manufacturing and quality control services at our state-of-the-art GMP certified facilities.

Our AMER DS facilities feature top-of-the-line single-use 500L cell culture bioreactors, 2000L microbial fermentation single-use bioreactors and stainless-steel fermenters, single-use chromatography, tangential flow filtration, and centrifuges.

Our AIGUAVIVA DS expansion facility features 2000L microbial fermentation single-use bioreactors and stainless-steel fermenters, single-use chromatography, tangential flow filtration, and centrifuges.

Our AMER DP facility features a high-speed isolator liquid vial filling line with 100% IPC.

Our AMER QC labs feature a wide variety of equipment enabling a wide range of methods; equipment is the same as used in the Analytical Methods development lab.

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Certifications

• EMA (EU GMP)
• World Health Organization (GMP / HACCP)

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Activity

• Abs (Antibodies), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, Injectables, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• DEA: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets: EMA (EU)

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Batch Size / Reactor

• Small, Medium, Large, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L

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Services

• Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, 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, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP

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