Customer Newsletter
Issue 8/09
Welcome to the NextPharma Sterile Product Development Center (SPDC) Update
We are delighted to tell you more about our SPDC in Braine l’Alleud, near Brussels in Belgium. The AFMPS (Belgian Regulatory Authority) approved site is a state of the art facility geared towards the needs of companies around the world requiring high-quality development-scale sterile clinical trials manufacture including full lyophilization capabilities. The new facility is designed to provide customers with a more efficient and faster option to develop, manufacture, label, store and distribute their products for clinical trials.
The SPDC's segregated clinical trials manufacturing suite has been qualified for highly potent products to Occupational Exposure Limits (OEL) 4, Safebridge 4, including small molecules, peptides, proteins, oligonucleotides and inactivated vaccines. Sterile solutions (water and solvent based), suspensions, emulsions and lyophilized formulations of highly potent or cytotoxic products can be filled into glass and plastic vials.
The SPDC's formulation development capabilities include lyophilization cycle development, manufacturing of batches for toxicology testing, scale-up studies, development and validation of analytical methods, drug product development (establishment of the composition), optimization (such as solubility and stability) and terminal sterilization.
The SPDC including the formulation development laboratories and clinical trials manufacturing units became operational in 2009. Indeed, within 48 hours of receiving GMP certification from the AFMPS, we began our first manufacture of a highly potent Investigational Medicinal Product (IMP) for a customer for whom we will also label, randomise, package and distribute the IMP to clinical trials centers.
To date, eight products have been formulated in the SPDC. This capability complements the GMP manufacturing of IMPs for clinical trials for which we have just received GMP certification and together with our clinical trial labeling, packing, storage and distribution services, provides a ‘one stop solution’ for clinical trial supply. As our customer’s products advance through clinical trials to the market place, we can offer scale-up and manufacturing of commercial volumes which is undertaken by our sterile commercial scale manufacturing facility located on the same site, which also has extensive expertise in cytotoxic molecule manufacturing and has undertaken development of IMPs and generic products for over twenty years.
The facility which has been designed to be fully compliant with FDA and European regulations, is also approved by the Japanese Ministry of Health, Labour and Welfare for manufacture and supply of finished products to Japan. All customer projects are underpinned by dedicated project management support at the highest level to meet individual customer requirements.
To find out more about how NextPharma can facilitate your outsourcing needs - please contact one of our Key Account Managers as detailed below.
Kind regards,
Sean Marett
Managing Director
Product Development Services
NextPharma Technologies
About the SDPC
The SPDC supports customers' pharmaceutical development projects from preclinical to clinical development and registration.
It offers services from pre-formulation and formulation development through to clinical manufacturing for Phase I to Phase II clinical trials with scale-up capability to Phase III and commercial scale on the same site with the ability to manufacture batch sizes for early phase clinical programmes of a few hundred rising to 110,000 vials of product for a Phase III clinical programme or commercialization.
These services are provided by scientists and experts in manufacturing and lyophilization cycle optimization who have over forty years collective experience in sterile manufacturing and lyophilization development.
The facility has been designed to a high level of containment, which together with stringent training and strict waste management procedures, allows the safe handling of highly potent compounds.
The facility's analytical laboratories provide a full range of biological and small molecules drug testing, analytical development and validation. All stability testing is undertaken to International Conference on Harmonization (ICH) guidelines.
The SPDC has the capability to provide products filled into glass and plastic vials and will shortly be able to provide pre-filled syringes and cartridges. We look forward to having the capability to provide liposomes and drug delivery systems from 2011.
A risk assessment of all new products entering the SPDC is performed prior to the start of pharmaceutical formulation development and clinical trials manufacturing.