Customer Newsletter
Issue 5/09
Welcome to the NextPharma Customer Newsletter
High potency drug development, manufacture and storage at NextPharma
At NextPharma we are aware of the market drivers fuelling demand for oncology and high-potency drugs. Strong growth in anticancer therapies and shifting patterns in drug development towards more complex and potent compounds are key factors driving demand for high-potency production capability.
NextPharma is an expert in the manufacture and development of ‘high potents’ such as cytotoxic, penicillins, cephalosporin and hormone drugs technologies and our people have considerable expertise and experience in this specialist area of production.
We have extended capacity for clinical trials services in line with customer needs and can scale up manufacturing from development to commercial quantities. We can also store and handle high potent products such as narcotics and biologics.
To find out more about how NextPharma can help you with all of your outsourcing needs please contact us on the numbers below.
With kind regards,
Bill Wedlake
CEO, NextPharma
High Potency expertise across NextPharma
Steriles and Cytotoxics
We have considerable ‘know how ‘ in contract manufacturing, packaging and control of cytotoxic products gained over many years at our Belgian site, in Braine l'Alleud.
In the same location - the Sterile Product Development Center (SPDC) operates in dedicated technical and GMP, cytotoxic and non-cytotoxic (bio and conventional) sterile suites, providing product development, clinical trials manufacturing, labelling, packaging and distribution, as well as scale-up services.
The SPDC can provide a seamless transfer to our sterile commercial manufacturing lines through close cooperation with our commercial production team. Our dedicated project managers are assigned to every customer to ensure 'on time - in full' delivery according to customer requirements and we can provide regulatory assistance in regulatory product filing.
At our FDA inspected steriles' facility in San Diego California we can provide bulk formulation, filtration and filling and lyophilization services aseptically and non-aseptically. We can also offer packaging and labelling and validation, documentation services and controlled product storage. Drug services are offered for preclinical/nonclinical, Phase I and Phase II work.
Clinical Trials Services (CTS)
We have extensive clinical trials expertise and have recently opened a major new facility in Göttingen, Germany to meet the growing demand from customers requiring the latest advances in the services of a premier CTS facility.
This facility has capacity in packaging suites for primary and secondary packaging and an extended cold storage area (2-8 °C and - 20 °C).
It has a dedicated packaging suite for secondary packaging of high potency drugs, such as cytotoxics and the capability to perform primary packaging under inert gas conditions, and a dedicated suite for the packaging of humidity sensitive investigational medicinal products is also available.
These facilities have been designed specifically to meet the needs of pharma, biotech, universities and contract research organizations.
As well as providing packaging and distribution services for non clinical, Phase I and Phase II clinical trials, the new facility can also offer greater packaging and distribution capacity for large Phase III and IV trials. It operates to strict cGMP guidelines, meets European compliance regulations.
Cephalosporins and Penicillins
We produce various cephalosporin dosage solid forms at our cephalosporins plant in Göttingen, while our Berlin facility ensures separate, dedicated production of penicillins and amoxicillin-clavulanic acid in solid and liquid forms. Both of these production plants offer a range of packaging options including alu-alu blistering, sachets and bottles.
Hormones
We produce three classes of hormonal substances - sexual hormones, corticosteroids and thyroid gland hormones at our FDA inspected site at Waltrop, Germany.
This site has packaging capability which provides specialized blistering and bottle filling of tablets, hard-capsules and soft-capsules containing sexual hormones.
Waltrop’s expertise in the production and packaging of semi-solids (gels, creams and ointments) and hormonal solids (primarily oral contraceptives) have now been combined creating expanded manufacturing capability to include the production and packaging of hormonal semi-solids.
Hormone production and packaging are operated separately in specialist contained areas, with separately contained personnel and material lockers and separately contained air conditioning systems.
Controlled substances Storage
We provide storage, handling and dispatching of controlled substances in modern temperature controlled and high-security warehouses.
In response to the rapid growth in demand for cold chain services our Cold Chain and Logistics business (CLS) in Austria has recently expanded its temperature controlled cold storage facilities by adding additional cold chain storage capacity to provide 280 cold storage pallet places at 2 - 8 °C.
We are also growing CLS further in Austria through a warehouse expansion that will create a facility with a 2,000 square meter area, 3,500 additional pallet spaces and temperature controlled storage at 15 - 25 degrees °C. This new facility is scheduled to be operational by September 2009.
This expansion compliments our US cold chain capabilities in San Diego where we offer controlled room temperature (15°C-30°C) down to -80°C, validated storage areas which are monitored 24 hours a day, seven days a week and can provide shipment to clinical sites and manage returned product control and destruction services.
Waltrop’s controlled substances warehouse provides logistics pre-wholesaling services and production and packaging of controlled substances. It also provides bulk production services of products where the API is a controlled substance, but the final product is an excluded product and primary and secondary packaging of controlled substances. We can provide for biologics and other products requiring storage and distribution at very low temperatures: deep freeze < -20°C, chilled 2-8°C and ambient (up to 25°C).