CMS Newsletter
Issue 2/10
Welcome to the NextPharma Contract Manufacturing Services (CMS) Newsletter
NextPharma Technologies Completes Expansion of its Waltrop Semi-Solids Hormones Facility in Germany
NextPharma has a long and successful history in the field of specialist contract manufacturing and in this edition of our newsletter we are delighted to tell you about the recent expansion of our hormones facility in Waltrop (Germany).
The expansion has created a dedicated hormone semi-solids area which is an extension of the existing hormone solids area (operational since August 2005). Work on the expansion took place between August 2009 and March 2010. Pre-inspection by the German Federal Authorities from Muenster / Westfalia was received in April 2010 and final qualification for the entire facility is expected in June 2010.
The new semi-solids area key figures are as follows:
- Surface area 240 m²
- 1 bulk production room
- 3 packaging rooms
- 1 cleaning area
- Blower locks operating as dust traps
- Personnel/material lockers
The area houses a new Becomix RW 1200 CD processing device with a 1,200 l production vessel (stirrer, homogeniser) and a 1,000 l pre vessel.
Packaging capabilities include suppositories, ovula and pessaries, ointments, creams and gels in aluminium tubes and canisters and stick packs.
To find out more about how NextPharma can facilitate all of your outsourcing needs - please contact one of our Key Account Managers as detailed below.
With kind regards,
Dr. Hermann Osterwald
Managing Director
Contract Manufacturing Services
NextPharma Waltrop
NextPharma Waltrop is FDA inspected and has extensive know how in development, contract manufacturing, packaging, quality control and logistics of hormonal products as well as conventional dosage forms (liquids and semi-solids). Waltrop has established an excellent reputation as a hormone specialist and also has expertise in manufacturing and packaging oral contraceptives.
NextPharma Waltrop has extended its capabilities through the addition of solid and
semi-solid production to its dedicated hormone facility with state of the art contained production areas, separate personnel and material lockers and separate air conditioning systems. The production unit manufactures three classes of hormonal substances: sexual hormones, corticosteroids and thyroid gland.
Additionally, Waltrop has established itself as a specialist for pump sprays for topical liquids in conventional dosage form production and can provide film coating of pellets as a ‘back-up’ to NextPharma Bielefeld.
Waltrop Product Development Services
Waltrop Product Development Services can provide formulation and analytical development for a complete range of oral and topical products with conventional and hormonal Active Pharmaceutical Ingredients (APIs) and New Chemical Entity (NCE) to Phase II clinical trials with scale-up capability to Phase III and commercial scale on the same site, in accordance with the highest regulatory requirements.
NextPharma Waltrop Logistics
NextPharma Waltrop Logistics operates from two distribution zones of 1,500 m².
Services & Capabilities:
- Center of Excellence for controlled temperature storage and distribution services
- Independent of wholesalers
- Pick-by-light System and scan technology
- Storage of controlled substances
- Storage 15-25°C
- Storage 2-8°C
- Storage at -20°C
- Temperature controlled storage
- Manufacturing authorisation
NextPharma Contract Manufacturing Services
This division provides commercial manufacturing and packaging of drug products that have successfully moved through clinical trials (in Product Development Services) or have been “transferred in” from a pharma company or other CMO. Products manufactured range from simple vitamin products sold “Over the Counter” to some of the World’s most important lifesaving prescription drugs.
About NextPharma
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of sterile injectables manufacturing, with particular expertise in pharmaceutical development and manufacture of oncology medicines.
We look forward to providing our customers with the benefits of our proven Product Development, Clinical Trials Services, Contract Manufacturing, Temperature Controlled Storage and Logistics Services
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
We offer a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing. We are a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally we have significant expertise in paediatric drug formulation, development and manufacture.
We operate globally with seven product development centres, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
We have 1,200 employees dedicated to serving over 200 customers world wide and a customer base, which includes many of the world's leading pharmaceutical, specialty pharma and biotech companies.
We have a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of our sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.