Eurofins launches cGMP-compliant clinical manufacturing through US and EU acquisitions
Continually enhancing its global laboratory services portfolio to meet clients’ evolving needs, Eurofins BioPharma Product Testing (EBPT) now offers cGMPcompliant clinical manufacturing and related services with the acquisitions of Sinensis Life Sciences B.V. and Advantar Laboratories, Inc. For projects in phase 1 and 2 of clinical development, EBPT delivers compliant, responsive, agile, cost-effective, and highly-flexible manufacturing options for preparing small-scale batches of drug products, medical devices, active pharmaceutical ingredients (APIs), and/or diagnostic kits. EPBT also offers associated clinical trial material kitting, randomisation, labelling, and logistics support.
Serving impressive and diverse clients, including the U.S. Army Medical Material Development Agency for the manufacture of an antibiotic cream, Eurofins Advantar Laboratories, San Diego, CA, supports customers’ clinical manufacturing and packaging needs with a highly experienced and capable staff plus a 1200 ft² (110 m²) manufacturing suite that includes an ISO 8 clean room. This FDA-inspected facility is ideal for GMP manufacturing of a wide range of non-sterile clinical products, including topical products, solutions, “atypical” APIs, reagents, and diagnostic kit components. Additionally, Eurofins Advantar provides a full range of formulation development, process development, clinical packaging, and analytical testing services.
Located in the Bio Science Park in Leiden, the Netherlands, Eurofins Sinensis houses cGMP manufacturing activities in two of its sites. Clean room suites in total of 861 ft² (80 m²) for handling “normal” products are located at Eurofins PROXY Laboratories, and an isolator for dealing with highlypotent compounds such as hormones and cytostatics (no penicillins and cephalosporins) is located at Eurofins MicroSafe Laboratories.
Eurofins Sinensis is highly specialised and experienced in manual fill and finish (F&F) of liquid parenteral products ranging from nasal sprays (0.1 – 5 mL) and ophthalmic solutions to vials (2 – 50 RDIN) and bottles (100 – 1,000 mL) to infusion bags (50 – 500 mL) to pre-filled syringes (0.5 – 50 mL) and cartridges (0.5 – 5 mL). Customers can supply a “ready-to-fill” bulk solution or the API which is subsequently compounded into bulk (max 100 Liter).
In addition to F&F services, Eurofins Sinensis offers related capabilities such as labelling, secondary packaging, storing and distributing (under a GDP license) and a large array of analytics from method development to qualification and validation, from release to stability. Also Qualified Person services as issuing Certificates of Conformity and batch certification belong to Sinensis’ services.
For more information, visit www.sinensislifesciences.com