NextPharma Technologies - Contract Manufacturing and Development, Regulatory and Analytical Services, Cold Chain and Logistics

NextPharma is a leading pharmaceutical, biotech and veterinary contract manufacturing and development organisation (CMO), with sites in Europe and the US for worldwide markets, including Japan and FDA-regulated markets. We offer a full-service one-stop shop supply or independent optional services, including regulatory, clinical trials, analytical services, cold chain and logistics.

In addition to its medical device manufacturing capabilities, NextPharma Technologies produces all classic pharmaceutical dosage forms such as:

• Solids (tablets, capsules, powders and controlled released pellets)
• Liquids (suspensions, syrups and solutions)
• Sterile liquids (ear, eye and nasal drops)
• Parenterals (vials and lyophilisation)

NextPharma Technologies also performs special containment production for:

• Injectable cytotoxics
• Hormones (solid and semi-solid)
• Narcotic controlled drugs
• Beta-lactam antibiotics (solids, liquids and dry syrups)
• Biologics (monoclonal antibodies, peptides, etc.)

Regulatory

Our plants in Braine (Belgium) and Waltrop (Germany) are FDA approved, our Göttingen (Germany) plant will follow later this year and the others in 2012. The PDMA has approved our Braine plant. Our plants Braine, Waltrop, Bielefeld and Göttingen are also approved by ANVISA. Together with approval from EMEA, Gulf States and South Africa, NextPharma is able to serve all major markets.

NextPharma undertakes special containment production of the following products.

Injectable cytotoxics – lyophilisation and vial solutions

We develop, manufacture and pack injectable cytotoxics vials (lyophilised or solution) at our site in Braine (Belgium). We perform formulation and manufacturing of clinical batches in our Sterile Product Development Centre (SPDC).

Semi-solid and solid hormone production

Our FDA-approved plant in Waltrop (Germany) performs development, manufacturing and packaging of hormonal drugs such as sexual hormones, thyroid gland hormones and corticosteroids.

Our packaging facility provides specialised blistering and filling into bottles of tablets, hardgel capsules and softgel capsules containing sexual hormones.

Ointments, creams and gels manufactured are filled in aluminium tubes, aluminium canisters and stick packs.

Beta-lactam antibiotics manufacturing services

We manufacture and pack cephalosporins and penicillins in solid (tablets, capsules, sachets and powder dry syrups) or liquid forms in our plants in Germany, which have gained experience over the years as Allphamed-Pharbil entities.

We are also equipped with specific climatic requirements to ensure production of amoxicillin-clavulanic acid drugs. Our packaging lines can ensure alu-alu blistering.

Narcotics and controlled drugs manufacturing services

We are experienced in manufacturing, packaging, and quality assurance requirements for controlled drugs with logistic-adapted warehousing.

Biologics development

We develop biologics in our Sterile Product Development Centre (SPDC), such as monoclonal antibodies.

NextPharma performs classic production of the following products.

Solids development and manufacturing

NextPharma offers development, clinical trials, manufacturing, packaging, cold chain and logistics of:

• Tablets
• Film-coated tablets
• Effervescents
• Pellets / micro-granules / DDS-modified released drugs
• Hard gelatine capsules
• Sachets
• Filling of powders / granules / tablets / capsules in bottles
• Alu-alu blister

We can perform aqueous or organic granulation, and we are ATEX-equipped to handle alcohol or solvents.

Development and manufacture of parenterals

Development, clinical trials, manufacturing, packaging, cold chain and logistics of injectable vials and lyophilised products for conventional APIs are performed in Belgium.

Our industrial plant produces lyophilisation and solutions, both in vials.

In our Sterile Product Development Centre (SPDC), we can start from very early stage of the lifecycle, from the molecule itself, to formulate the appropriate pharmaceutical form or to optimise existing formulations to get appropriate lyophilisation cycles (for instance) and then gain productivity for further industrial batches and therefore save costs of API and save time in the market supply chain.

The centre is able to work on liposomes and poorly soluble APIs as well as highly viscous products such as hyaluronic acid. Filling can be done in vials or syringes.

Development and manufacture of sterile products

We develop, manufacture and pack sterile products such as ophthalmic drops in plastic multi-dose vial, and nasal and ear drops.

Development and manufacture of liquid pharmaceuticals

We develop, manufacture and pack batch sizes up to 10,000l of syrups, solutions and suspensions. NextPharma is equipped to handle alcohol or solvents. We can fill in plastic or glass bottles:

• Pump sprays
• Drops
• Sachets
• Drinkable ampoules

We can also insert spoons, dosage cups, pipettes or paediatric syringes into the packs.

Development and manufacture of semi-solids

We develop, manufacture and pack semi-solids forms such as gels, creams, ointments and suppositories.

Our plant in Germany is FDA-approved.

Our offering is based on a one-stop shop concept, enabling our customers to have within a single partner the possibility to save time to market access, costs and risks.