Lancaster Laboratories – Cell bank manufacturing
Jeff Kelly, Online Industry Editor

Lancaster Laboratories offers cell bank manufacturing services, including manufacturing, storing and characterizing mammalian cell banks like master, working and research banks and expertise in cold-chain management. Its manufacturing facility is cGMP-compliant and includes multiple ISO 7 clean rooms and ISO 5 critical areas that are compliant with aseptic processing guidelines. Lancaster Laboratories also offers fully validated manufacturing procedures including process simulation studies to insure manufacturing process integrity.

Read the full product review

Innovative approach to Phase I and Phase II clinical trials cuts both time and cost

The accelerated proof-of-concept (AcPOC) study design streamlines clinical trial work by combining four studies into a single integrated solution.  In a study on an allergy treatment, POC studies were combined with single ascending dose (SAD), multiple ascending dose (MAD) and preliminary food effect studies, all of which require the development of assays to measure concentration of the drug in the blood of the study participants. Running these four studies sequentially can take up to 28 to 36 weeks, while an AcPOC study can be conducted in 14 to 18 weeks.

“There is tremendous pressure on pharmaceutical and biotech companies to save money while still providing safe and effective treatments. The accelerated proof-of-concept design helps assess drug candidates more quickly and at less cost,” said Dr. Troy McCall, CEO of Cetero Research. “For small and mid-sized firms, the need to establish POC is essential in securing financing or hitting the next milestone payment.”

“Organizations can see huge savings in the amount of staff training time and time to implement the study when they use the AcPOC approach,” said Dr. Graham Wood, President of Clinical Operations for Cetero’s Toronto and Miami facilities. While AcPOC can be used for a variety of therapeutic studies, different areas necessitate the integration of different study types. Therefore, both time and financial savings will differ from study to study.

Best-in-Class Patient Assay Development Providers:

• Run positive and negative reference controls in replicates of 8-16 in wells on the outside columns of the microtitre plates.
• Use plates that all have positive and negative reference controls.
• Run compounds in primary screens in singlets only.

Top Considerations Before Selecting Assay Development Provider:

Characterization of the stability of the assay reagents is very important and some regulatory inspections have uncovered deficiencies in this area. The manufacturer’s quality control (QC) group usually performs the task of characterization, which should include assessments of the compound identity, the purity, the concentration or titer of the material, the storage conditions and the expiration date. Check to make sure that potential assay development providers use adequately characterized standard assay reagent reference material with appropriate documentation.

Key Producers:

1. Rules-Based Medicine (RBM) , a CLIA-certified biomarker testing laboratory, has developed a proprietary Multi-Analyte Profile (MAP) platform to provide reproducible, quantitative multiplexed immunoassay data for hundreds of proteins. In order to achieve the sensitivity and dynamic range necessary to quantify the target analyte, each assay is first developed as a single-plex test and then the resulting single-plex assays are aggregated. Validation of these multiplexed assays with a battery of analytical procedures completes the development process. RBM also offers therapeutic-specific MAPs custom designed for late-stage clinical development. Corporate headquarters and biomarker testing laboratory are in Austin, TX; multiplex assay development and manufacturing is in Lake Placid, NY and a wholly owned subsidiary is in Germany.

2. Brighter Ideas, Inc.'s “GFP-on-a-String” is a proprietary biomedical test for proteases and protease inhibitors using green fluorescent protein (GFP). With highly specific protease tests, which measure only one protease type or class, often dozens of separate assays have to be run in order to identify an unknown protease. Bii reports that "GoaS automatically, in one, very high sensitivity test, measures any protease present in the sample while providing a precise identification of that protease with respect to a large electronic data base. No other protease assay does this sort of 'fingerprinting'." Bii, founded in 2003, focuses on advancing fluorescent protein technology through research and by offering educational programs. This company is located in Metuchen, NJ.

3. The Jackson Laboratory’s JAX® Mouse Diversity Genotyping Array Service is based on its proprietary high-resolution genotyping array, which enables high-density, genome-wide profiling of single nucleotide polymorphisms (SNPs). This array covers 100 times more SNPs than any other available mouse array and can simultaneously assay over 620,000 phylogenetically informative SNPs for the characterization or comparison of mouse DNA samples. In addition to conducting genetic research into ways to prevent cancer as well as to discover drugs to treat conditions including: cancer, diabetes, Alzheimer’s and cardiovascular disease, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. The Jackson Laboratory is an NCI-designated Cancer Center with facilities in Maine and California.

4. Cetero Research offers a large portfolio of assays as well as services for bioanalytical clinical trials. Cetero’s bioanalytical services support clinical, preclinical drug and biomarker analysis for small and large molecules. This company reports that “Our 50 instruments offer substantial capacity to analyze your samples…in a high-throughput environment to meet the most demanding schedules.” Cetero Research has two state-of-the-art facilities in Houston TX and Toronto, Canada. The Toronto facility offers organic synthesis capabilities for synthesizing metabolites. Its bioanalytical labs use InnaPhase's Watson™ Laboratory Information Management System (LIMS) for laboratory control and report writing. This company was formed in 2006 and 2007 by the merger of five research companies that had all been in business since the 1980s.

Assay Development
Definition: An assay is a procedure for measuring a process, like enzyme activity, antigen capture, stem cell activity and competitive protein binding, or the amount of a drug or biochemical in an organism or organic sample.