CMO UNVEILS TESTING SERVICES
FILL/FINISH specialist SCM Pharma has launched two new testing services to complement its sterile manufacturing capabilities and reduce the risks associated with offsite testing for client projects.
The UK-based contract manufacturing organisation (CMO) has introduced Sterility and Bacterial Endotoxin Testing (BET) to its GMP-compliant facility, which will supplement its existing analytical, stability and microbiological testing capabilities.
Both methods are set to be rolled out for clients on a number of recently secured contracts by SCM Pharma following the full validation of both testing services.
Dianne Sharp, managing director at SCM Pharma, said: "The launch of these in-house testing services is a major milestone in the firm's development in that it allows us to fill, test and release sterilised product for our clients all under one roof.
"Not only will this reduce the potential risk of loss, breakage, documentation issues and delays associated with offsite testing but by allocating testing slots straight after sterile filling, our clients are likely to get their product even quicker.
"As our customers either need product for precise clinical trial dates or to meet ongoing commercial market supply requirements, these new offerings will be a huge added benefit to new and existing client projects."
The in-house sterility testing is performed within a validated grade A environment utilising a sterility test isolator situated within a cleanroom facility. Using an isolator as opposed to other conventional methods will help reduce the potential for costly delays and lengthy investigations.
BET meanwhile is performed in a designated area of the microbiology laboratory using the Quantitative Turbidimetric Assay technique. Aimed at reducing lead time and minimising risk for client projects, BET is performed using GMP compliant computer software allowing quick generation of COAs and results.
The new testing services are a logical addition to SCM's Pharma's established in-house aseptic processing and terminal sterilisation capabilities that allows the company to fill ampoules, vials and syringes.
Looking after clients in the pharma, biotech and medical device sectors needing clinical trial supply and niche low volume licensed products, SCM Pharma specialises in the fill/finish of novel, difficult and dangerous drug products. Its specific expertise includes the filling of highly potent products, radio-labelled compounds and non-live biologicals.