• Development
  • Drug development

Drug development

Our systematic approach to medicinal-product development has proven successful when selecting product components and when determining the optimum process for product manufacture.

Focus on the active ingredient

The starting point of our development activities is always to precisely and comprehensively characterise the active pharmaceutical ingredient or combination of multiple active ingredients.

Optimum project planning and execution helps us achieve your defined objectives. We also work with development tools from lean management and lean development and consistently implement the methods and processes of this lean management.

 

We have the expertise!

Active pharmaceutical ingredients

The quality of active pharmaceutical ingredients is identified by a series of chemical and physical characteristics, which have a critical impact on the stability and efficacy of a medicinal product. Knowing the chemical and physical nature of the active ingredient and optimising as required is vital for successfully developing a medicinal product.

We also investigate the following parameters:

  • Content or activity
  • Chemical degradation products, light sensitivity
  • Particle sizes, particle shapes
  • Polymorphism, crystallinity
  • Compatibility of active ingredients and excipients
  • Solubility
  • Stability

If a certain quality of an active pharmaceutical ingredient needs to be sought and applied, we can offer our customers the following services:

  • Active pharmaceutical ingredients sourcing in accordance with current regulatory requirements (e.g. generic API in accordance with EP and USP)
  • Active pharmaceutical ingredients obtaining (with partners)
  • Active pharmaceutical ingredients-IP search

 

Product

We are specialised in the development of solid, semi-solid and liquid dosage forms with chemically defined and biological active ingredients. These include oral, topical, inhalational and parenteral medicinal products.

Interconnecting services in formulation, medicinal-product analysis and marketing authorisation within the HWI group enables us to offer medicinal-product development as a complete package or in individual modules.

Product development covers:

  • New development of medicinal products and related products
  • Development of innovative products for poorly soluble active ingredients or new applications
  • Product optimisations
  • Generic developments
  • Development of herbal medicinal products
  • Development analysis
  • Manufacture, packaging, release and distribution of clinical test samples
Development analysis

Analysis is a vital core element of medicinal-product development and monitors the success of individual steps in formulation development. We can provide you with all aspects of development analysis:

  • Test-method development/validation
  • Stress tests, stability testing
  • Batch-release testing
  • Updates to specifications and test methods as well as regulatory processing (variation management)

We use the following methods and technologies to perform our analytical work:

  • Differential scanning calorimetry (DSC)
  • Laser light scattering (LLS)
  • Chromatography (HPLC, UPLC, LC-MS, GC, GC-MS)
  • In vitro dissolution according to EP and USP (apparatus 1, 2, 4)
  • Infrared spectroscopy (FT-IR)
  • Biological analyser
  • New generation impactor (NGI, testing of powder inhalers according to EP and USP)
  • RAMAN spectroscopy (RAMAN CI), with partner
  • X-ray microtomography (XMT), with partner
  • X-ray diffractometry (XRPD), with partner
  • Electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX), with partner
  • Troubleshooting analysis in the event of active ingredient, formulation or product issues
Risk-based development

Upon request we can develop medicinal products in accordance with the current requirements of the ICH-Q8 to ICH-Q10 guidelines. Not only will you gain an in-depth understanding of the process, you will also benefit from the rigorous science- and risk-based development concepts. This approach, also known as quality by design (QbD), in medicinal-product development is based on a prospectively defined target product quality profile. The medicinal-product development is focused on critical quality attributes and the influence of all steps in the manufacturing process on these quality attributes. By using the principles of static design of experiment (DoE), we generate the data sets that can be used to define a corridor within which flexible and reliable process management is possible.

Our services include:

Preparation of proposals, which may include the following:

  • Milestone-based activities
  • Performance of risk analyses
  • Creation and selection of suitable DoE models, also as part of a QbD
  • Model implementation of feasibility studies
  • Statistical evaluations of formulation results
  • Scale-up of prototype formulations, also from DoE studies
  • Stability testing of prototype formulations, also from DoE studies
  • Definition of the design space
  • Scale-up of confirmation batches
  • Production of validation and stability batches
Dosage forms

In our technical centre we can develop and produce solid and liquid formulations for oral use as well as semi-solid formulations according to ICH guidelines in small to medium-sized batches. We can also conduct work on highly toxic substances or substances with unknown toxicity.

  • Solid dosage forms: tablets, coated tablets, sugar-coated tablets, hard capsules, pellets, granules, powder
  • Semi-solid dosage forms: creams, gels, emulsions
  • Liquid oral dosage forms: solutions, suspensions
  • Dosage forms with modified active-ingredient release: rapid release, delayed release and enteric-coated dosage forms
  • Parenteral dosage forms in cooperation with external partners

Dr. Alexandra Keilbach-Bermann
Drug Development & Production / Quality

Phone: +49 7805 401-502
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0