Customer Newsletter

NextPharma New Sterile Product Development Centre (SPDC)

Braine l'Alleud - Brussels from Mid 2007

This new facility will support customers’ projects through pre-formulation work, formulation development and through to clinical development with scale-up capability in our Braine l’Alleud manufacturing facilities, in accordance with the highest regulatory requirements.

All clinical materials will be manufactured and supplied in accordance with the requirements of FDA, EMEA and other regulatory agencies.

The facility’s analytical laboratories will also provide a full range of biological and small molecular drug testing and conduct stability programmes according to ICH guidelines.

Product Development Services (PDS)

Our PDS capabilities include:

• Formulation, development and scale-up of a wide range of sterile, solid, semi-solid and liquid dosage forms with specialization in cytotoxics, hormones and antibiotics
• Development of line extensions and novel product presentations
• Development and validation of analytical methods for raw materials and finished products as well as for impurity profiling
• Stability studies in accordance with ICH
• Pharmacokinetic profiling of oral dosage forms
• Preparation of documentation and compilation of technical section of dossiers for registration
• Packaging and manufacturing of clinical trial materials, including for special drug classes
• Organisation of study protocol, distribution and return programmes for clinical trial supplies
• Full service approach to development of drug dosage forms

Pharmaceutical Development

Services:

• Development of formulations, manufacturing procedures and analytical methods
• Product optimisation and scale up
• Pilot batches and product transfer
• Packaging design
• Stability testing

Capabilities:

• Innovative product development and line extensions

Analytical Services

Services:

• Development and validation
• Documentation for registration purposes
• Storage of stability batches in different climatic zones
• Stability testing
• Quality control of raw materials, bulk and finished products

Microbiology and Hygiene Service

Microbiological control of:

• Sterile products (cat. 1)
• Oral products (cat. 3A and 3B)
• Topical products (cat. 2)
• Water for pharmaceutical purposes
• Special products (e.g. foils, transdermal products)
• Cosmetics

Clinical Trial Packaging (CTP)

Services:

• Assistance in the implementation of packaging design including aspects of safety, compliance and premarketing
• Requirements planning and purchase of packaging materials as well as sourcing comparative medication
• Blinding of solid dosage forms in capsules and blinding of other forms
• Bulk manufacture of active and placebo products
• Deblistering of commercial products
• Filling, packaging and labelling including randomisation
• Label printingDrawing up of randomisation lists and emergency letters
• Analytical and stability testing during studies
• Compared release of blinded forms
• Processing of controlled substances
• International distribution and shipping

Specialty:

• Blister cards