Surrey, UK, 3rd February, 2011 - NextPharma the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotech industry, is pleased to announce the appointment of Brigitte Genard as Quality Director at its sterile contract development and manufacturing site in Braine-l’Alleud, Belgium.
Ms. Genard will take responsibility for all aspects of quality across the Braine-l’Alleud site, including the recently FDA and PDMA inspected contract manufacturing plant which produces oncology products in commercial quantities and the Sterile Product Development Center, a centre of excellence for high-quality, formulation development and manufacture of investigational medicinal products including full lyophilization capabilities.
Ms. Genard is an Industrial Pharmacist with 18 years of experience in Quality Assurance and Production. She has extensive experience in biopharmaceutical manufacturing, has worked for 15 years in industrial vaccine operations (bulk and secondary) and has previously worked for GSK Biologicals and UCB Bioproducts as Senior Quality Assurance Manager and Head of Production.
On this appointment Bill Wedlake, CEO, NextPharma Technologies, commented: ‘We are delighted to have Ms. Genard join our management team heading up the Quality function in Braine-l’Alleud. Her broad experience across our industry will enhance our ability to match the demands of our customers ensuring that NextPharma remains at the forefront of timely, competitive, healthcare outsourcing solutions of the highest quality’.
NextPharma’s main sterile contract manufacturing plant in Braine-l'Alleud has extensive know how in aseptic production and packaging including the manufacture of cytotoxic products (lyophilization and solutions) gained over more than fifteen years and a growing capability in the manufacture of biologics and pre-filled syringes.
NextPharma’s Sterile Product Development Center supports customers' pharmaceutical development projects from pre-formulation and formulation development through to investigational medicinal product manufacturing with lyophilization for Phase I to Phase II clinical trials with scale-up capability to Phase III and commercial scale in our commercial manufacturing facility on the same site, in accordance with the highest regulatory requirements.
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 injectables manufacturing, with particular expertise in product development and manufacture of oncology medicines.
NextPharma has recently been acquired by Sun European Partners with a view to leveraging NextPharma’s strong track record, reputation and state of the art facilities, to grow the business both organically and by acquisition.
Chief Executive Officer
NextPharma Technologies Holding Limited
Tel +44 (0) 1483 479 121
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
NextPharma offers a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing for New Chemical Entities (NCEs)/New Biological Entities (NBEs) and generic products. The company is a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Its sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally NextPharma has significant expertise in paediatric drug formulation, development and manufacture. NextPharma offers ‘one-stop’ logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP/GDP regulations.
NextPharma operates globally with seven product development centers, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
NextPharma has 1,200 employees dedicated to serving over 200 customers worldwide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies.
NextPharma has 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 its sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.