Microtest Laboratories has announced the expansion of its fill and finish manufacturing service for all Phases of clinical trials. The company provides flexible, customizable aseptic processing and fill/finish services for all pharmaceutical producers conducting Phase 1, 2, or 3 clinical trials.
“Virtual companies and smaller pharma manufacturers with no infrastructure for manufacture can partner with Microtest to provide their clinical trial material to clinics in an efficient and timely manner. Large manufacturers that don’t wish to divert high-capacity production lines will find Microtest a fast, efficient, cost-effective alternative, ” said Alex Mello, Director of Project Management, Microtest. “Manufacturers of any size will discover a partner in Microtest with all the specialized knowledge, experience, and facilities they need.”
Microtest provides the flexibility for all types of pharmaceutical and biopharmaceutical manufacturing. Microtest will formulate per the approved batch record, which may include mixing, agitation, heating/cooling, etc. Microtest can provide problem solving experience to any of the specifics of a manufacturer’s process. Post formulation, Microtest’s analytical capabilities allow for a full spectrum of available in-process tests to ensure that the drug product is formulated to the strict specifications set by the manufacturer. Post in-process testing, filtration occurs utilizing the manufacturer’s specified filtration system, redundant as applicable. The product is filled into the designated vial type/size specified by the manufacturer as well as stoppered and capped using the manufacturer defined container closure system. Product is filled, capped and sealed under an ISO Class 5 environmental area.
Post fill, the product undergoes full 100% manual visual inspection, which is quality-controlled post-inspection by a qualified operator by performing an AQL inspection. Product is labeled per approved labels and stored in Microtest’s fully validated material control department at a multitude of storage conditions.
“As Microtest is a leader in testing of pharmaceutical drug products, we offer the full release package on-site thereby ensuring the most expeditious release of the product,” Mello said. “The specification documents allow for maximum efficiency when the samples are taken and released to our QC laboratories – both QC Microbiology and QC Analytical. Our representatives can discuss the testing on any final drug product specification and determine the most efficient release strategy.”
Microtest fill/finish operations comply with both U.S. FDA and European EMEA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.