Biopharma Virtual Tour

Capabilities & Capacity. Compliance. Collaboration.

A client recently told us, “We need to get it done quickly, but need to get it right.” From Early Phase to Marketed Release, our breadth of testing capabilities, regulatory experience, and strategic client partnerships produce the most timely and trusted GMP Biochemistry and Potency Assay services.

Capabilities & Capacity: More really is more.

Giving you that one-stop experience for your complete range of testing needs provides consistency of quality systems and regulatory compliance, efficient sample management, 24/7 data access and relationship continuity to better accomplish your timeline objectives.

Working in harmony to support all Characterization, Stability & Release project goals, our 80,000 square feet of dedicated lab space, testing capabilities, and state-of-the-art instrumentation enable us to proficiently advance projects of any size.

Capabilities

With redundancy of key instrumentation and cutting-edge technology, such as Micro-Flow Imaging (MFI) for subvisible particle analysis and MALDI-TOF/TOF, our analysts have the tools to carry out routine analyses, as well as complex investigations.

Full method development and validation capabilities are available to support methodology for determination of purity, concentration, identity, and monitoring impurities and process residuals.  A wide range of instrumentation is utilized including capillary electrophoresis, iCE, HPLC/UHPLC (SEC, IEX, RP, and HIC) and mass spectrometry.

Capabilities

Multiple mass spectrometry platforms support performing full product characterization, including top/down characterization, intact mass determination, peptide mapping, sequencing, glycan analysis, subunit analysis, disulfide bond mapping, and monitoring of post translational modifications. 

Potency assays are an essential aspect of establishing the effectiveness and safety of biopharmaceutical products.  They are performed to determine the biological activity or potency of the product, a critical product attribute according to ICH Q5B.

Capabilities

Due to their complex nature, bioassays are often challenging to perform.  Skilled analysts having a thorough understanding of cell physiology are key to successful bioassay development, validation, method transfer and long-term assay maintenance.

Providing a dedicated turnkey service for all binding and cell-based potency assay needs, our bioassay teams in Munich and Lancaster work closely together to design and execute customized binding assays and cellular in vitro bioassays.

We have a success rate of greater than 95% on potency assay transfers.  We also have more experienced PhDs than any other contract laboratory, all dedicated to troubleshooting problematic assays and developing new assay platforms and methodologies.

Offering a comprehensive range of GMP microbiological services in support of sterile product testing, we have one of the largest Microbiology Departments in the industry, assuring that you will have the resources necessary to complete your project quickly and efficiently.

As a pioneer in the microbiology outsourcing industry with over 25 years’ experience, we perform thousands of sterility tests each year.

Break loose force, glide force, and needle safety guard activation force are tests performed for pre-filled syringes using the Instron model 3343 single column table frame.

Our new 17,000-square-foot Stability building houses a large capacity ultra-low temperature (-80°C) walk-in (equivalent to 36 reach-in chambers), capacity for 10 LN2 cryogenic freezers, and more than 25 different set points for stability chambers, including all ICH conditions, as well as risk mitigation with redundant controls, 24-hour camera monitoring and back-up generators.

Having the largest Stability Storage capacity in the US with 80,000 cubic feet of storage in 80 chambers capable of all specialized storage conditions (temperature, light and humidity), enables us to offer the most comprehensive cGMP storage-only and storage/testing options for Bio/Pharmaceutical and Medical Device clients.

Compliance: It's what really matters.

Clients have told us for decades our experienced scientists and quality assurance staff instill confidence that they count on for impeccable quality systems, metrics reports and compliant data.

With a 60-year track record of delivering high-quality data, for us, regulatory compliance begins and ends with our expert team rigorously trained to enforce strict GMP protocols.

Collaboration: Success is in the details.

Behind every good service is a great scientist working with you to deliver the highest standards of customer satisfaction and project perfection.

We help clients effectively allocate their research and manufacturing dollars by strategically engaging them with close communication and collaboration.

Backed by our long history of fostering thousands of client relationships, we approach each project as a vested partnership; when your project succeeds, we succeed.

Capabilities & Capacity. Compliance. Collaboration.

This is where it all comes together. It's one thing to have state-of-the-art instrumentation and facilities, yet quite another to house some of the industry's brightest scientific minds who transform science into an outstanding service experience.