Customer Newsletter
Issue 7/09
Welcome to the NextPharma Customer Newsletter
Clinical Trial Services
In this edition of the NextPharma Customer Newsletter we are pleased to tell you about the expansion of our Clinical Trial Services (CTS). This growth is in response to our customers’ increased clinical supply needs in the current market, where time constraints, cost pressure and the growing complexity of trials is forcing many organizations to turn to outsourcing experts for clinical development support.
Our expanded capabilities have been designed specifically to meet growing demand from our long-term customers and offer our CTS capabilities to new customers by providing them with the latest advances in clinical trials labeling, packaging and distribution services worldwide. In particular, our services have been designed to complement formulation development and manufacture of clinical trials material in response to customer requests for an integrated formulation, manufacturing and packaging service.
NextPharma has been providing Clinical Trials Services to customers since 1976, including packaging, labeling and distributing products for oncology, cardiovascular, pulmonary, central nervous system, alimentary, hormonal and dermatology studies to clinical trials centers around the world. In addition to adult clinical trials, demand has also increased for paediatric trials following the changes to regulatory approval of new chemical entities in Europe.
Our Clinical Trials Services facilities are designed to meet the global clinical trial supply needs of pharmaceutical and biotechnology companies, universities and contract research organizations. We have expanded our core capabilities through the addition of CTS at our San Diego, California site in the United States, complementing our recently expanded CTS capabilities available from our Göttingen site in Germany. NextPharma CTS capabilities at both sites include randomization, double-blinding, generation of emergency letters, packaging, kitting, labeling (Phase I – Phase IV studies), cold-chain storage, distribution, drug accountability and destruction.
The San Diego Clinical Trials Services facility has dedicated rooms for primary and secondary packaging and labeling as well as extensive capabilities for long-term temperature controlled storage from 15 – 30°C to -80°C as well as distribution for Phase I through IV clinical trials.
Our Göttingen facility services customers conducting trials in the United States, Canada, Europe, Russia, the Ukraine, Africa, Asia, and Australia and operates to strict cGMP guidelines. It has extensive capacity in primary and secondary packaging and an extended cold storage area (2-8°C and -20°C). It has a dedicated suite for secondary packaging of high potency drugs, such as cytotoxics and the capability to perform primary packaging under inert gas conditions. In addition, a dedicated suite for the packaging of humidity sensitive investigational medicinal products is also available. It has expanded packaging and distribution capacity for large Phase III and IV trials.
Our Göttingen and San Diego sites work together with our other strategically located depots to distribute clinical supplies for our customers’ global clinical trials. In conjunction with the expansion of CTS, NextPharma has invested in additional project management resource to provide dedicated project support at the highest level to meet individual customer requirements.
For further information on our CTS capabilities, or if you would like to know more about how NextPharma can facilitate your Product Development, Contract Manufacturing or Cold Chain Logistics needs, please click on the contact links below or visit our website on www.nextpharma.com.
With kind regards,
Bill Wedlake
CEO, NextPharma
Pharmaceutical Forms
Solids & Semi-solids
- Tablets (film-coated, chewable, effervescent, dispersible)
- Hard gelatine capsules
- Granules
- Pellets
- Ointments, gels, creams, emulsions, suspensions
- Suppositories
- Foams
Liquids & Sterile
- Aspetic
- Syrups and oral liquids
- Topical sprays
- Parenteral liquids
- Nasal sprays
- Eye and ear drops
Special Product Capabilities
- Cytotoxics (freeze-dried and solution)
- Biologics (freeze-dried and solution)
- Hormones (solid and semi-solid)
- Penicillins (solid)
- Cephalosporins (solid)
- Controlled substances (solid)
- Plus: conventional drug classes (semi-solid and liquids)
Packaging and Labeling
Primary packaging
- Primary packaging with nitrogen cover gas
- Bottle filling (HDPE, Glass)
- Blister packaging (PVC/PVDC/Alu-Alu/COC, Aclar)
- Sachet filling
Secondary packaging
- Blister cards
- Dedicated suite for secondary packaging for high potent drugs
Special label design & printing
- Booklet labels
- Tear-off labels
Storage, Distribution and Destruction
Storage under GMP conditions
- Controlled room temperature, 15-25°C, 2-8°C, -20°C
Distribution of Drugs & Patient Kits
- Controlled room temperature, 15-25°C, 2-8°C, -20°C
Return & Reconciliation of drugs
Manage Destruction of drugs
CTS Manufacturing
Blinding
- Over-encapsulationof IMP's (Investigational Medicinal Products)
Manufacturing of matching placebo
De-blistering of IMP's
Analytical Services
- Method transfer, development and validation
- Stability testing and storage according to ICH guidelines
- Testing of API and excipients
- Import and EU release testing
- Microbiological investigation according to pharmacopeia