Biological Services

Aspira Chemical offers a single-source, back integrated approach for development of New Biological Entities (NBEs). We are uniquely poised to leverage multiple state-of-the-art platforms to provide a full gamut of biologics solutions to our clients–notably in the discovery through IND-Phase I stages–while ensuring IP protective mechanisms are consistently applied. Our collaborative scientists possess over 15 years expertise with proteins, gene therapeutics, antibodies (monoclonal), and large MW peptides. Translational upstream execution is balanced by downstream PR&D activities. These programs are carried out adjacent to global centers of biotechnology excellence in Asia.

Our high-value, cost-efficient biological services include:

• Molecular Biology Services
• Assay Development Services
• Protein Expression Services
• Protein Purification and Solid-State Services
• Custom Protein Production

Molecular Biology Services

From Gene-to-Protein, Aspira Chemical can readily initiate customized programs at the DNA staging point and handle the early translational discoveries that require further validated studies. Our world-class scientists utilize a broad array of scientific backgrounds and expertise at this critical stage of drug discovery. The molecular biology program often starts with our evaluating the desired gene for further construct design, cloning, and transformational generation.

Our molecular biology program includes:

• DNA and RNA gene cloning
• Gene cloning, optimization, and synthesis
• Gene modifications–DNA sequence modified by transformants
• Transfection–stable or transient cell manipulations
• Site-directed mutagenesis
• Epigenetic profiling
• Protein target validation by X-ray structural determination

Assay Development Services

At Aspira Chemical, the extensive experience and proven achievements of our collaborative scientists enable us to offer customized assay profiling through development platform service to clients ranging from pharmaceutical to biotech to genomic centers of excellence onto academic institutions. All of our bioassays can be integrated with ASPIRA’s full suite of proteomic capabilities, or delivered independently.

The salient features of our assay development services include:

• Biochemical assays secured based upon clients’ “use-driven” needs
• Coordination of R&D technology transfer of client-developed assays
• Screening assays are optimized and validated
• Compound screening and targeted libraries for: GPCRs, Kinases, Proteases, Ion Channel, and N(H)Rs
• Active screening assays of cellular systems to identify drug candidates for downstream validation
• Bioassay functionality readouts: fluorescence, luminescence, colorimetric, and/or radio-assays
• Dynamic protein and DNA binding assessment in dynamic fashion via cell-based assays
• Toxicity assessment by biomarker discovery assays (i.e., liver enzymes via P450 oxidation)
• In Vitro ADME panel screens for hit-to-lead target/off-target effects

Protein Expression Services

Aspira Chemical provides the broadest array of technology platforms for expression of high-purity proteins including yeast and rice. We enable transfection of the appropriate host platform together with the suitable regulatory elements that yield very high levels of production performed at an initial scale-up reactor size of 50 L. By leveraging our deep domain expertise and complementary integrated services, our protein scientists can accelerate the pre-IND to clinical time frames and significantly control cost structures moving downstream in larger bioproduction campaigns.

Our unparalleled protein expression services include:

• Broad expression systems’ expertise: Yeast, E. Coli, Baculovirus, Rice, and Mammalian
• Protein engineering and process development controls
• Protein labeling and co-expression service options
• Pilot scale for Proof-of-Concept (POC) batches at 50 L
• Full analytical support for POC lot-to-lot batch release and COA formulation
• Analysis of protein expression system impurities

Protein Purification and Solid-State Services

Aspira Chemical can readily build biologics testing parameters that are custom tailored to our clients’ specific project requirements. We have a variety of analytical instruments that are applied to assess protein purity and impurity identification, including a world-class Rigaku™ Diffactometer data collection unit for determining protein-protein, protein-drug candidate, as well as protein-ligand structures.

Our analytical instrumentation and methods used are highlighted below. Other methods can be developed upon request.

• Drug-binding assays to proteins; cellular assays for cytokine release
• Non-denaturating electrophoresis for MW and disulfide polymerization
• Ion Exchange and Size-Exclusion Chromatography
• LC/MS and RP-HPLC method development, method transfer, and method validation (non-GLP)
• SDS-Page for assessment of protein purity; SDS-MS is also available upon request
• Endotoxins tests for microbial and other impurity contents by RT-PCR and QPCR
• Protein product release testing as well as stability storage and testing
• Critical raw materials testing
• X-ray structural determinations for protein-protein complexes of crystal grade
• Structural determinations by Rigaku™ diffraction data collection of protein-drug complexes
• Crystallization screening on customized basis

Custom Protein Production

By using either insect cell cultures (Baculoviral systems) or our rice (Oryza Sativa) expression platform, we can develop a customized protein production program based on the clients’ requirements. We first optimize the desired protein expression system and design the production campaigns around purification, process engineering, and employ larger reactors/reactor trains for rapid scale-up. These custom services consist of endotoxin clearance validation at protein product specifications and lot release is done for final COA affirmation. Final deliverables are agreed upon early in the proposal evaluation stage. As your strategic partner for biologics drug commercialization, Aspira Chemical creates intelligent, custom tailored solutions with the superiority of the Baculoviral and rice endosperm expression technologies, expanded manufacturing capabilities from grams to metric tons, and integrated analytical services to accelerate project timelines.

For more information about our comprehensive suite of biological capabilities, please contact collaborate@aspirasci.com.