CDMO: an industrial approach for low volumes

Petits lots - maladie rare

Small-scale manufacturing requires a specific type of organization: more agile and responsive, yet equally rigorous.

At Unither Pharmaceuticals, we leverage our industrial expertise and flexible model to support your small-batch manufacturing projects. Whether you need to produce an orphan drug, a seasonal treatment or a hospital product, or launch a specialty, we adapt our resources to your challenges.

Our strength: an infrastructure designed to meet specific demands or project-specific constraints, without over-engineering the process and offering great flexibility, and always in compliance with the most stringent quality standards.

pédiatrie

A dedicated CDMO for rare-disease drugs

Manufacturing drugs for rare diseases, a pediatric treatment, or compassionate use is never an ordinary operation.

At Unither Pharmaceuticals, we have developed specific expertise in small-batch production for drugs targeting rare diseases and high-value therapeutic treatments.
Every batch counts.

For these patients with no alternative, we mobilize all our rigor, quality requirements, and responsiveness. For us, manufacturing is much more than an industrial act: it means providing a vital response to patients.

vétérinaire

Small veterinary batches: same requirements, same flexibility

Our low-volume manufacturing capacities are also available to the veterinary sector, where the need for targeted commercial batches is increasingly common.

We support laboratories specializing in the development and production of specific veterinary products.

Find out more about our services for veterinary treatments

Low-volume manufacturing, beyond rare diseases

Our organization ensures efficient and adapted production, including for very small series, while preserving quality and regulatory compliance.

Our low-volume manufacturing capacities are also suited to other use cases:

Phased launches, in one or more markets

Seasonal products and products for occasional distribution

Specific products for hospitals or low-volume distribution

A dedicated site in France for small series

Bordeaux

Our Bordeaux site, in France, is specifically designed for low-volume production:

  • Manufacturing for sterile and non-sterile liquid, semi-solid, and solid formats
  • Flexible volumes from a few hundred liters, grams, or units
  • Equipment dedicated to small series, with high adaptability
  • High responsiveness, adapted project management, simple and direct management

Why choose UNITHER for your small commercial batches?

Solid experience in orphan diseases and specialized drugs

Flexible production capacities, adapted to small series for sterile and non-sterile, semi-solid and solid formats

A personalized approach, designed for each product and indication

A high level of quality compliance and traceability

An integrated CDMO, from pre-formulation to commercial production

FAQ - manufacturing for small pharmaceutical batches and drugs for rare diseases

Unither has expertise in the development and production of solid, liquid, and semi-solid forms, offering tailored solutions for each project. This includes the development and production of placebos that are perfectly identical in appearance, taste, and texture to the active products. This ability is particularly important in the case of double-blind clinical trials, where the level of resemblance of placebos is a key success factor.

 

 

An orphan disease, also known as a rare disease, is a condition affecting a very limited number of patients. In Europe, it is defined as a disease affecting fewer than one in 2,000 people.
These diseases often require specific, scarcely available treatments, necessitating tailored pharmaceutical production in low volumes.

Small commercial batches involve low-volume production for drugs that are typically intended for niche markets, small numbers of patients (rare diseases, pediatric programs), or phased launches. At Unither, we can produce batches as small as just a few hundred units.

Unither has developed considerable expertise in the production of drugs for rare diseases.

Although our industrial capacities are primarily scaled for large-scale production, we have made the strategic choice of maintaining a site dedicated to small-batch production.

This allows us to effectively meet the specific needs of these rare treatments, with high standards and a strong commitment to helping the patients concerned.

Yes. Unither has a dedicated site in Bordeaux, France, that is specifically designed for small-batch commercial production, including for orphan drugs.

This site offers a high level of flexibility and operates in compliance with regulatory requirements, ensuring compliant manufacturing tailored to small volumes.

Yes. Unither develops and manufactures small batches prior to industrial scale-up to ensure product performance and efficient industrialization.

Small volumes are handled at a dedicated, flexible site designed for small-batch production, in strict compliance with international pharmaceutical standards (GMP).
This approach allows you to verify the formulation, stability, and industrial feasibility of a product before transfer to our commercial production sites.