HWI group

The HWI group is an innovative and independent partner of the pharma, medtech and biotech industries. Today we offer our services for active ingredients, medical devices and associated products at our sites in Rülzheim and Frankfurt (HWI pharma services GmbH), Appenweier (HWI development GmbH) and Planegg (HWI regulatory services GmbH).

Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Quality control

In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

Development

The active ingredient is at the heart of our risk-based formulation development. Its properties have a critical influence on the quality of the product. In our ultra-modern clean rooms we can also work with highly potent active ingredients. By using statistical design of experiment (DoE) we offer an efficient pharmaceutical development that completely fulfils the requirements of quality by design.

Drug development

HWI Campus
Technology platforms

Technology platforms

Our technology platforms for lean product development, troubleshooting or other complex matters relating to medicinal products.

We offer:

Analysis platform

Broad range of established and innovative chemical and physical measurement methods
For chemical, biological and herbal active ingredients and ready-to-use products
Rapid results in product development
Quality control for batch release and stability testing
Strategies to identify contaminants
Rapid troubleshooting of medicinal-product quality problems

Technology platform for prolonged-release tablets

HWI formulation technology for delayed active-ingredient release from the tablet
The retardation matrix is adjusted to the chemical and physical properties of the active ingredient
For chemical and herbal active ingredients
Optimum retardation matrix using design of experiment (DoE) concept
State-of-the-art analytical methods to monitor success

Technology platform for poorly soluble active ingredients

Solubility improvement for poorly soluble chemical and biological active ingredients
Micronisation and nanonisation technologies, silica carrier
Efficient screening to select the suitable technology

Technology platform for the appropriate administration route

The aim is to achieve the greatest possible bioavailability of the active ingredient
For chemical, biological and herbal active ingredients
Rapid or delayed active-ingredient release, sustained-release forms
Formulation choice:
- Oral: tablets, capsules, granules, pellets, gels
- Parenteral: solutions, microsuspensions, nanosuspensions
- Nasal: sprays, gels
- Pulmonary: dry powder inhalers (single-dose inhalers)