Drug development
HWI has been a leading company in drug development for many years. Our experts take innovative therapeutic approaches from conception to market launch. As a CDMO, we also develop and manufacture for our customers on a contract basis. Our services include formulation development and manufacture as well as analytical method development and characterisation for for solid, semi-solid and liquid medicinal products.
Innovative technologies in drug development
With our many years of experience and state of the art technological equipment, we offer both galenic and analytical drug development for a wide range of dosage forms. In addition to traditional manufacturing processes, we rely on innovative technologies. Nanotechnology in particular represents a key focus area.
Our aim is to optimise the bioavailability and efficacy of drugs while minimising side effects.
An overview of our technological equipment can be found here: Formulation equipment
CMC development
We focus on the development and manufacturing of small to medium-sized batches of different dosage forms for oral, topical, nasal and parenteral use. In our clean rooms we are able to work with high potent active ingredients (up to OEL4 / OEB 5) as well as with substances of high or unknown toxicity. Interlinked formulation development, analytical testing and regulatory services within HWI group enable us to offer drug development as a complete package or in individual modules.
Drug development services include:
- Development of new drug products
- Development of innovative products for poorly soluble active ingredients or new applications
- Optimisation and reformulation of existing products
- Generic developments
- Development of herbal medicinal products
- Analytical method development and validation
- Manufacturing, primary and secondary packaging, release testing and release as well as distribution of clinical trial medication
We help you develop, manufacture and characterise the following dosage forms:
Liquid dosage forms
Solutions, micro- and nanosuspensions, emulsions and lyophilisates are developed for oral, nasal and parenteral use.
Semi-solid dosage forms
Semi-solid dosage forms such as creams, oleogels and hydrogels, emulsions and self-emulsifying systems (SEDDS, SMEDDs) are used for topical application.
Solid dosage forms
Tablets, coated tablets, hard capsules, pellets, granules and powders are the most common solid dosage forms for oral use.
Can't find the dosage form you are interested in? Or does your product need a special manufacturing process? Feel free to get in touch with one of our experts about our customised solutions.
Drug development
Our drug development is based on the precise and comprehensive characterisation of the active pharmaceutical ingredient, whether as a single substance or in combination with other ingredients. For this purpose, we draw on a wealth of experience, a highly qualified team of experts and a wide range of analytical methods.
The quality of active pharmaceutical ingredients has a significant influence on the stability and bioavailability 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 therefore examine the following parameters, among others:
- Content or activity
- Chemical degradation products, light sensitivity
- Particle size distribution, particle shape and morphology
- Polymorphism, crystallinity
- Compatibility of active ingredients and excipients
- Solubility
- Stability of active ingredient and drug product
If a specific quality of active pharmaceutical ingredient needs to be sourced, we can offer our customers the following services:
- Active pharmaceutical ingredient sourcing in accordance with current regulatory require-ments (e. g. generic API in accordance with EP and USP)
- Active substance development / advancement and production (with partners)
- Patent and property right research for active substances
In addition to conventional manufacturing processes, we also offer innovative technologies to meet the requirements of new active ingredients. With customised solutions, we develop the necessary prototypes for your product in the initial development steps and a robust formulation for the clinical development and later market phase.
Our technologies – solid dosage forms
- Manufacture of granules, direct blending and capsule filling
- Manufacture of granules, direct blending and processing into tablets and film-coated tablets
- Manufacture of pellets and filling into capsules
- Manufacture of ODTs
- Manufacture of buccal tablets
- Primary (bottles, blister packs, containers) and secondary packaging of powder mixtures, tablets and capsules
Our technologies – semi-solid and liquid dosage forms
- Manufacture of solutions and suspensions (via wet bead milling and high pressure homoge-nisation)
- Production of emulsions
- Manufacture of oleo- and hydrogels
- Manufacture of lyophilisates
- Production of PLGA-based sterile microparticles
- Primary (vials, syringes, cartridges, bottles, tubes, tins) and secondary packaging of liquid and semi-solid dosage forms
- Manufacture of oral solutions and emulsions and filling into hard capsules
In drug development, analysis is an essential core element in monitoring the success of each step in the formulation process in order to ensure the quality, safety and bioavailability of a medicinal product. This includes the identification and quantification of active ingredients, excipients and any impurities that may be present in a medicinal product.
We offer the following analytical development services:
- Analytical method development and validation
- Stress and stability testing (e. g. according to ICH)
- Batch release testing
- Updating of specifications and analytical test methods and regulatory support (e. g. variation management)
We have access to the following analytical methods and technologies, among others
- Chromatography (HPLC, U(H)PLC, LC-MS, GC, GC-MS) with a wide range of detection options for small and large molecules
- Electrophoresis
- In vitro dissolution according to EP and USP (apparatus 1, 2, 4)
- Differential scanning calorimetry (DSC)
- Laser diffraction for the determination of particle size distributions (PSD) (Malvern Mastersizer 3000)
- Dynamic light scattering (DLS) and zeta potential (Malvern Zetasizer)
- Laser diffraction for the determination of droplet size distributions (DSD) (Sympatec Helos-BR-SPRAYER-ROTOR)
- Bioanalyzer
- Infrared spectroscopy (FT-IR)
- UV/VIS photometer
- Electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)
- Nuclear magnetic resonance spectroscopy (NMR, qualitative and quantitative)
- Scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM-EDX)
- RAMAN spectroscopy (RAMAN CI)
- X-ray microtomography (XMT)
- X-ray diffractometry (XRPD)
- Titration (water analysis, ion-selective electrodes)
- Atomic absorption spectroscopy with graphite tube and flame atomizers (AAS)
Would you like to know more about the analytical capabilities of HWI? Then take a look at our analytical section: Laboratory services
Contact us. We’re happy to help!
Katja Klein
Sales Manager
Phone: +49 7272 7767-2735
Email: k.klein@hwi-group.de
Dr. Philipp Wissel
Frankfurt Site Manager
Phone: +49 7272 7767-0
Email: p.wissel@hwi-group.de