Drug development
Drug development

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

Active pharmaceutical ingredients (API)

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

Innovative technologies for the manufacturing of medicinal products

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

Analytical development

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

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Q&A

What is drug development?

Drug development involves the chemical and physical characterisation of the desired active substance, development of a suitable formulation, analytical testing, upscaling of the formulation to production scale, and pre-clinical and clinical testing. This is a complex and multi-stage process aimed at developing and producing safe and effective therapeutics for human use.

What are the phases of drug development?

Drug development is divided into different phases in which efficacy, safety, tolerability and dosage are tested. These include the pre-clinical phase and clinical phases 1 to 3.

Who approves clinical trials?

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute are responsible for approving clinical trials. In addition, a favourable opinion from an independent ethics committee is usually required to protect the rights, safety and well-being of trial participants.

How are clinical trials carried out?

Clinical trials are conducted in several phases, each with specific objectives and methods. They may be randomised, placebo-controlled and double-blind to ensure the objectivity and validity of the results.

How long does it take to get a medicinal product approved?

On average, it takes 10-15 years from the discovery of an active ingredient to the approval of a medicine. If a known compound is used in a new medicinal product to be developed, this time is reduced.

What is the difference between a CDMO and a CMO?

In the pharmaceutical industry, a contract manufacturing organisation (CMO) is a contract manufacturer that produces various intermediate products of a medicinal product or the final product on a contract basis.

In addition to manufacturing a product, some companies also provide support in research and development, formulation development and other analytical and pharmaceutical areas. These companies are called contract development and manufacturing organisations (CDMO) or contract manufacturers and developers.