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KBI Biopharma, Inc.

Durham, North Carolina, US

KBI is a biopharma contract development & manufacturing organization driven to improve the quality of human life – we do this by serving our clients in the accelerated development of their needed medicines.
To date, we’ve served over 200 clients around the world.

We help our client partners accelerate and optimize drug development and manufacturing programs by offering an extensive suite of expert development and manufacturing services in an agile, client-friendly partnering environment. Clients include global pharmaceutical and biotechnology companies and academic/non-profit organizations. Today we serve more than 200 clients in the US, Canada, Europe, Korea and Japan, including most of the top ten pharmaceutical companies. KBI was founded in 1996 and is based in Durham, North Carolina, near Research Triangle Park (RTP).

KBI’s extensive track record of successful process development and manufacturing... Show more »

KBI is a biopharma contract development & manufacturing organization driven to improve the quality of human life – we do this by serving our clients in the accelerated development of their needed medicines.
To date, we’ve served over 200 clients around the world.

We help our client partners accelerate and optimize drug development and manufacturing programs by offering an extensive suite of expert development and manufacturing services in an agile, client-friendly partnering environment. Clients include global pharmaceutical and biotechnology companies and academic/non-profit organizations. Today we serve more than 200 clients in the US, Canada, Europe, Korea and Japan, including most of the top ten pharmaceutical companies. KBI was founded in 1996 and is based in Durham, North Carolina, near Research Triangle Park (RTP).

KBI’s extensive track record of successful process development and manufacturing programs is a result of our unique approach of applying the insight gained from our biophysical and biochemical protein characterization methodologies, towards the development of robust and scalable processes. KBI delivers expert and integrated process development and cGMP manufacturing of recombinant protein Active Pharmaceutical Ingredients (API) for our clients.

KBI’s scientific, quality and regulatory staff offers extensive experience – proven through numerous IND and NDA submissions – to meet the challenges that arise at all stages of drug development.

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Alliance Protein Laboratories

San Diego California
No Reviews Available

Alliance Protein Laboratories, a division of KBI Biopharma, is a contract research firm specializing in biophysical analysis. We offer a broad and unique range of biophysical characterization services, including analytical ultracentrifugation (AUC), circular dichroism and... Show more »

Alliance Protein Laboratories, a division of KBI Biopharma, is a contract research firm specializing in biophysical analysis. We offer a broad and unique range of biophysical characterization services, including analytical ultracentrifugation (AUC), circular dichroism and fluorescence spectroscopy, light scattering (SEC-MALS and DLS), and DSC. We also offer contract purification services (research scale).

APL is a spin-off from the Protein Chemistry department at Amgen. It was founded in 1998 by Drs. Tsutomu Arakawa and John Philo. Our laboratory is located in San Diego, CA. Our clients include over 400 companies in North America, Europe, Asia, and Australia as well as major universities and non-profit institutes.

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KBI Biopharma, Inc. has not listed any services.

Computational Fluid Dynamics (CFD)
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Computational fluid dynamics (CFD) is a first principles technique in which the differential equations describing fluid, mass and heat transfer are solved computationally for a fluid contained in a specific geometry. CFD can be used to characterize mixing in process vessels, estimate gas mass transfer in bioreactors or understand... Show more »

Computational fluid dynamics (CFD) is a first principles technique in which the differential equations describing fluid, mass and heat transfer are solved computationally for a fluid contained in a specific geometry. CFD can be used to characterize mixing in process vessels, estimate gas mass transfer in bioreactors or understand flow distribution in chromatography columns. This technique is most beneficial in situations where taking experimental measurements is very difficult or expensive and a more complete understanding is required for successful process scale-up or transfer.

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ICH Stability Testing
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Bioprocess Development and Scale-Up
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Biopharmaceutical Process Development
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The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible and scalable processes. KBI’s extensive process development capabilities help our partners generate active product at an attractive cost while enabling rapid, reliable transfer to cGMP manufacturing.

KBI process development... Show more »

The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible and scalable processes. KBI’s extensive process development capabilities help our partners generate active product at an attractive cost while enabling rapid, reliable transfer to cGMP manufacturing.

KBI process development activities cover the full development cycle, from supporting early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies. We take pride in our deep knowledge and experience in the science and practice of biopharmaceutical drug development. Our abiding customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients’ biopharmaceutical process development needs.

KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture derived proteins. Our team’s combined experience includes more than 50 IND submissions and more than 5 commercial launches. The KBI team has worked with protein production processes at all scales from laboratory, pilot and clinical scales to commercial scales up to 20,000L. We have conducted cutting-edge research into several technologies that are fundamental to process development and are adept at solving challenging issues on very short timelines.

KBI has well-developed platform processes for monoclonal antibodies and Fc fusion proteins and has helped several clients create their own platforms for novel therapeutic moieties.

Our high throughput tools for process development include miniaturized bioreactors through the Ambr® platform combined with high throughput chromatographic screening capabilities and a complementary set of analytical tools to enable rapid progress in process development. Through our experience, we can readily develop optimal experimental strategies that can lead to the rapid development of robust, reliable and scalable processes.

KBI’s full range of process development capabilities provide the tools to address client needs, whether they be in producing small quantities of proteins for research or in developing robust and scalable processes that can provide a solid competitive advantage.

Process Development Service offerings include:

  • Selection of clones (productivity, stability)
  • Cell line adaptation (e.g. to serum-free or suspension culture)
  • Development of reproducible, robust and scalable processes
  • Optimization of existing processes
  • Development of process control strategies
  • Development of novel technologies
  • Scale-down model qualification
  • Scale-down validation studies
  • Technology transfer package and support
  • Approaches and documentation aligned with QbD
  • Cell line evaluation
  • Medium development (animal component free)
  • Development of nutrient feed strategies to prolong culture life and production
  • Identification of critical process parameters
  • Production at pilot scale for preclinical studies
  • Development of platform approaches
  • Scale-down process characterization studies
  • Viral clearance validation studies
  • Application of design of experiments during development and process design space mapping
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Predictive Modeling
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Advanced computer modeling and simulation techniques can provide KBI customers increased process understanding while at the same time minimizing investment in costly experimentation. KBI staff has extensive experience developing and applying computer modeling tools in the biotechnology industry. Our modeling capabilities include... Show more »

Advanced computer modeling and simulation techniques can provide KBI customers increased process understanding while at the same time minimizing investment in costly experimentation. KBI staff has extensive experience developing and applying computer modeling tools in the biotechnology industry. Our modeling capabilities include mechanistic unit operation modeling, computational fluid dynamics (CFD), process modeling and plant simulation.

Mechanistic Modeling

Mechanistic models leverage scientific and engineering knowledge to develop a mathematical description of the fundamental processes occurring within the unit operation. These models typically require some experimentation to define model parameters, after which predictions can be made with respect to unit operation performance over a wide range of operating parameter conditions. Mechanistic models can be used for process optimization, evaluating process robustness and to fully characterize performance of the unit operation within a specified operating space.

Computational fluid dynamics

Computational fluid dynamics (CFD) is a first principles technique in which the differential equations describing fluid, mass and heat transfer are solved computationally for a fluid contained in a specific geometry. CFD can be used to characterize mixing in process vessels, estimate gas mass transfer in bioreactors or understand flow distribution in chromatography columns. This technique is most beneficial in situations where taking experimental measurements is very difficult or expensive and a more complete understanding is required for successful process scale-up or transfer.

Process Modeling

Process modeling utilizes mass and energy balances combined with information about the process and production facility to understand process and facility fit. Costs for raw materials, capital, labor and disposables are then incorporated to calculate the overall cost of goods. Application of process modeling during process development is essential to ensuring a cost effective process.

Plant Simulation

Plant simulation combines process and facility information (process sequence, process timing, equipment availability, etc.) into a mathematical framework that enables optimization of facility run rate via constrained optimization techniques. Plant simulation is used to understand the impact of process, equipment or operational changes on the maximum run rate of a facility as well as to support finite scheduling in manufacturing. Application of plant simulation ensures the process you are developing or the facility you are designing will deliver the capacity target you expect.

At KBI, we are passionate about leveraging computational tools to improve process development in the biotechnology industry and integrating modeling and simulation into our process development activities is one of the ways KBI ensures robust and cost efficient processes.

  • Modeling and Simulation Service Offerings*

  • Development of mechanistic unit operation models

  • Application of mechanistic models for chromatography and ultrafiltration

  • Application of Computational Fluid Dynamics (CFD) to biotechnology unit operations for equipment design or process troubleshooting

  • Perform process modeling to improve process throughput, evaluate facility fit and understand cost of goods- - -- Perform plant simulation to optimize new or existing facility capacity

  • Application of modeling to evaluate process or platform improvements

  • Application of modeling to evaluate facility or equipment designs

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Post-Translational Modification Analysis
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Disulfide Bond Mapping by LC/MS/MS
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Cell Proliferation Assays
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Cytokine Release Assay
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qPCR
Quantitative PCR
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ELISA
Enzyme-linked immunosorbent assay
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PAGE
Polyacrylamide Gel Electrophoresis
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Western Blot
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Capillary Electrophoresis
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HPLC
High Performance Liquid Chromatography
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  • Size Exclusion
  • Reverse Phase
  • Affinity
  • Ion Exchange
  • Hydrophobic Interaction
  • Size Exclusion
  • Reverse Phase
  • Affinity
  • Ion Exchange
  • Hydrophobic Interaction
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Glycan Analysis
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  • Oligosaccharide mapping
  • Sialic Acid Quantitation
  • Monosaccharide composition
  • Oligosaccharide mapping
  • Sialic Acid Quantitation
  • Monosaccharide composition
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Dynamic Light Scattering
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Differential Scanning Calorimetry (DSC)
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FT-IR
Fourier transform infrared spectroscopy
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CD Spectroscopy
Circular dichroism spectroscopy
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Peptide Mapping
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Amino Acid Analysis
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Pharmaceutical Formulation
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KBI’s approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:

  • Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein.
  • Employing statistical design-of-experiment (DOE) to evaluate main effects and... Show more »

KBI’s approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:

  • Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein.
  • Employing statistical design-of-experiment (DOE) to evaluate main effects and interactions effects on protein stability

Together, these techniques enable KBI to develop robust formulations by eliminating uncontrolled stability variables, thus placing the focus solely on therapeutic performance and clinical outcome.

Advantages of the KBI Biopharma Approach

KBI Biopharma’s approach to preformulation and formulation development result in significant savings to the client by eliminating the variables associated with suboptimal formulations.

Preclinical development efforts in PK, PD, ADME and toxicology occur with confidence that additional uncontrolled variables from unstable formulations are not introduced into the study.

This benefit extends far into clinical trials as well, where assessment of toxicity, dosage levels and efficacy are profoundly influenced by an optimal formulation that conserves the three dimensional conformation of the therapeutic protein. KBI’s data-driven approach can also strengthen responses to regulatory inquiries.

KBI Formulation Development Experience

The KBI team has completed more than 80 successful protein, peptide, and vaccine formulation development programs. Liquid, lyophilized, and suspension formulations developed by KBI have been successfully transferred to many fill/finish CMO’s and utilized for the manufacture of clinical and commercial drug product for parenteral administration (IV infusion, IV push, SC, IM).

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In vitro PK/PD Studies
In vitro pharmacokinetics/pharmacodynamics
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Immunoprecipitation
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UV-VIS Spectroscopy
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Quality Assurance
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Recombinant Protein Expression
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Project Management
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Contract Services Directory
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Drug Preformulation
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Mass Spectrometry
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Vaccine Production
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Protein Manufacturing
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Peptide Manufacturing
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Clinical Trials Supply Manufacturing
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Biopharmaceutical Manufacturing
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Pharmaceutical Manufacturing
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Mammalian Cell Culture
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Lyophilization
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Forced Degradation Studies
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Downstream Processing
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Contract Research
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Contract Development And Manufacturing Organization (CDMO)
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Chemistry, Manufacturing and Controls (CMC)
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Stable Cell Line Generation
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KBI has been applying established mammalian and microbial recombinant protein expression systems to provide rapid cell line generation services using:

  • CHO K1, CHO-DG44 and PER.C6® platforms
  • AOX1-based methanol inducible systems in Pichia pastoris
  • E. coli expression systems

KBI has been applying established mammalian and microbial recombinant protein expression systems to provide rapid cell line generation services using:

  • CHO K1, CHO-DG44 and PER.C6® platforms
  • AOX1-based methanol inducible systems in Pichia pastoris
  • E. coli expression systems
    • Soluble
    • Insoluble
    • Periplasmic

Both transient expression and stable pool generation approaches are available to support proof-of-concept (POC) material generation for preclinical programs designed to meet the client’s timeline and budgetary objectives.

The cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development programs. Selected cell lines are used for the generation of KBI internal research cell banks (RCBs). For full scope process development and cGMP manufacturing programs, the master cell bank (MCB) generation is outsourced to established third party vendors. KBI conducts quality audit of a vendor, transfers distribution vials of the selected RCB to the third party facility, manages and provides quality oversight of the pre-bank testing, the MCB production, testing and release under cGMP.

The key considerations for cell line development programs include:

  • Understanding of business and science driven objectives related to the expression platform choice, e.g. IP status and licensing terms,
  • Applying established, commercially proven expression platform systems in order to streamline subsequent process development activities,
  • Implementing ICH Q5D and ICH Q5B guidelines,
  • Gene and codon optimization of the expression plasmids,
  • Clone selection based on Product yield, quality, expression stability and cell culture performance,
  • Verification of critical Product quality attributes by integrating extensive analytical support into early steps of the clone selection process.

Additionally, KBI offers reporter cell line generation for cell-based assay development programs. These programs range from pre-clinical method transfer or development to cGMP qualification and validation in support of clinical and commercial Drug Substance and Drug Product release and stability testing.

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Biopharmaceutical Development
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Biopharmaceutical Manufacturing
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Biological Testing
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Assay Development
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Aseptic Processing
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Analytical Validation
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Analytical Method Development
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KBI has successfully completed over 300 analytical projects for more than 100 clients and more than 130 distinct molecules. Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylated proteins, protein vaccines, PEGylated proteins, conjugates, peptides and... Show more »

KBI has successfully completed over 300 analytical projects for more than 100 clients and more than 130 distinct molecules. Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylated proteins, protein vaccines, PEGylated proteins, conjugates, peptides and other proteins. KBI expertise includes HPLC, CE, ELISA, UV-Vis, mass spectrometry, light scattering, biophysical characterization (DSC, CD, FTIR, fluorescence), binding assays (ELISA, Biacore, Forte Bio), glycan analyses, cell based assays, and others. We routinely provide STAT analytical support for process development (e.g., DOE sample analysis) and manufacturing (HPLC and other methods for titer, purity, etc.).

KBI employs a phase-specific lifecycle approach to analytics. During method development, the stability-indicating capabilities of methods are evaluated via forced degradation studies. Method parameters are optimized to improve resolution and recovery of the product-related impurities. As part of method development, key performance criteria such as specificity for degradation products (stability-indicating capability), linearity, precision, system suitability, etc., are evaluated. These development data serve as range-finding tools for subsequent protocol-driven qualification and validation studies.

KBI typically performs qualification of non-compendial product specific methods in order to demonstrate their suitability for use in release and stability testing of drug substance and drug product intended for Phase I/II clinical studies. KBI recommends that full validation be performed prior to utilizing methods during process validation / conformance lot manufacture and use of drug substance and drug product for Phase III clinical studies.

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Analytical Chemistry Services
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Accelerated Stability Testing
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Project and Process Management
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Experimental Design
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Process Consulting
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Biology
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Omics
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Proteomics
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Cell-Based Assays
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Cell Viability & Proliferation Assays
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Cells and Tissues
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Cell and Tissue Culture
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Microbiology
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Microbial Fermentation and Bioprocessing
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Biochemistry & Molecular Biology
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Protein Services
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Protein Expression Visualization
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Protein Sequencing
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Protein Characterization
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Protein Production
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Protein Quantification
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Biomolecular Interaction Analysis
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Nucleic Acid Services
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DNA Services
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PCR
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Imaging & Spectroscopy
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Spectroscopy
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Spectrophotometry
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Infrared Spectroscopy Services
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Scattering Techniques
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Chemistry and Materials
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Chromatography
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Liquid Chromatography
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Electrophoresis
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Gel Electrophoresis
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Formulation Services
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Manufacturing Services
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Product Development, Testing, and Packaging
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Product Quality Control
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Engineering and Fabrication
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Physical Analysis Methods
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Calorimetry
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Strength Analysis
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Pharmacology & Toxicology
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Immunoassays
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Bioanalysis
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Bioanalytical Assays
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In vitro Bioavailability/Bioequivalence Studies
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Data Services
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Computational Modeling
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Fluid Analysis
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Fluid Analysis Services

Fluid Analysis Services

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Product Testing Services
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Product Testing Services

Product Testing Services

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