NextPharma has a long and successful history in the field of product development and in this edition of our newsletter we are delighted to update you on some of our more recent global PDS achievements in sterile product development, contract manufacturing and clinical trials services.

PDS supports customers’ development of investigational medicinal products through providing services for formulation development, analytical testing, including stability testing to International Conference on Harmonization (ICH) guidelines, clinical trials manufacturing, clinical trials packaging, and storage and distribution of product in final form to clinical trials centres or to a location of the customers’ choosing.  We have developed products from the early phase of development all the way through to commercial manufacturing and our service in the preparation of the Chemistry, Manufacturing and Control (CMC) section of a regulatory filing is helping many of our customers obtain drug approvals from regulatory authorities that they seek.  We have successfully worked with peptides, proteins and small molecules including in the last 12 months, a cytotoxic oligopeptide and a protein, sensitive to light, temperature and shear.

We pride ourselves on our scientific excellence, state-of-the-art facilities and modern project management methods allowing execution of customers’ projects to demanding timelines. As a result of this we have a very high rate of returning customers.
 
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.

Sean Marett
Managing Director
Product Development Services

2009 Score Card: Formulation Development and Investigational Medicinal Product Manufacturing of Sterile Products located near Brussels, Belgium
6 aseptic formulation development projects;
15 aseptic investigational medicinal product manufacturing batches.

NextPharma's new Sterile Product Development Center located in Belgium is a state of the art facility that became fully operational in 2009.


The facility is geared towards the needs of companies around the world requiring high-quality development-scale sterile investigational medicinal product manufacture including full lyophilization capabilities for both cytotoxic and non-cytotoxic peptides, proteins and small molecules. It provides for formulation development and sterile investigational medicinal product manufacturing to Phase II clinical trials with scale-up capability to Phase III and commercial scale in NextPharma's commercial manufacturing facility on the same site, in accordance with the highest regulatory requirements.

The new facility is designed to provide customers from the US and Europe with a more efficient and faster option to develop and manufacture their products for clinical trials and is FDA and EU compliant.

2009 Score Card: Clinical Trials Services  located in Göttingen, Germany
45 Studies corresponding to 35,000 patient kits from:
Phase I: 22 studies;
Phase II: 15 studies;
Phase III: 8 studies.

NextPharma’s modern Clinical Trials Services facility located in Göttingen, Germany, has extensive capacity in packaging suites for primary and secondary packaging and an extended temperature controlled 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. Moreover, a dedicated suite for the packaging of humidity sensitive investigational medicinal products is also available.

This facility has been designed specifically to meet the needs of pharmaceutical companies, biotechnology companies, contract research organizations and universities. As well as providing packaging and distribution services for non clinical, Phase I and Phase II clinical trials, the facility can also offer greater packaging and distribution capacity for large Phase III and IV trials.  It operates to strict cGMP guidelines, meets all European compliance regulations and is in the process of being validated to meet FDA regulatory requirements.

For more than 30 years, the Göttingen facility has been manufacturing, analysing and packaging investigational medicinal products. The Göttingen Clinical Trials Service facility with its extensive experience in packaging, storing and distributing peptides, proteins and small molecules can meet all requirements and expectations of its customers and can provide seamless and timely execution of multi-site clinical trials supply across a number of countries simultaneously.

2009 Score Card: Investigational Medicinal Product and Device Manufacturing; Clinical Trials Services located in San Diego, United States
14 aseptic fills projects in just fewer than 40 separate sterile manufacturing batches;
215 non-aseptic liquid projects in separate batches;
14 Clinical Trials Services Projects;
266 shipments and four new long term storage contracts for biotechnology products put in place.

NextPharma’s San Diego new Clinical Trial Services capabilities were added in 2009 to reflect customer requests to be able to offer both clinical trials manufacturing and clinical trials packaging of investigational medicinal products in the United States. This new service includes randomization double-blinding, generation of emergency letters, packaging, kitting, labelling (Phase I – Phase IV studies), temperature controlled storage, distribution, return accountability and destruction. Because the service mirrors that of our European clinical trials packaging service undertaken in Germany, we are able to distribute product to clinical trials centers in North America, South America, Europe and Russia seamlessly.

NextPharma San Diego serves small to large companies world-wide in the biotechnology, pharmaceutical, diagnostic, and medical device markets. Its aseptic area has multiple clean room suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms. This facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing. We have experience in manufacturing small molecules, peptides and biologics.