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Avista Pharma Solutions, Inc.

Durham, North Carolina, US

Avista Pharma Solutions is a contract development, manufacturing, and testing organization that understands what it takes to rapidly advance products through every stage of development. With over 200,000 square feet of laboratory and manufacturing space in the U.S. and U.K., Avista Pharma offers a broad suite of scientifically differentiated services ranging from early stage discovery, API and Drug Product development and cGMP manufacturing to stand-alone analytical and microbiology testing support. Led by our broad experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our clients—success that goes beyond science.analytical and microbiology testing support.

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Elemental Analysis
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Spray Drying
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Lyophilization
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Impurity Synthesis
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Product Stability Testing
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Avista Pharma has over 3,000 square feet Stability areas that include over 25 environmental chambers for pharmaceutical Stability Studies across three (3) locations. We can accommodate studies of various container and lot sizes, temperatures, humidities, lights and lengths of study. With fully-compliant GMP analytical chemistry... Show more »

Avista Pharma has over 3,000 square feet Stability areas that include over 25 environmental chambers for pharmaceutical Stability Studies across three (3) locations. We can accommodate studies of various container and lot sizes, temperatures, humidities, lights and lengths of study. With fully-compliant GMP analytical chemistry and microbiological labs, Avista Pharma is your one-stop Stability Testing Partner with redundant storage locations for business continuity.

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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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For Drug Metabolism and Pharmacokinetic (DMPK) studies, Avista Pharma has extensive experience in bioanalytical analyses to support discovery and pre-clinical drug metabolism studies utilizing state-of-the-art LC/MS/MS instruments. In addition, the Avista Pharma team has experience with metabolite identity (ID) from such studies (described above in Impurity Identification).

For Drug Metabolism and Pharmacokinetic (DMPK) studies, Avista Pharma has extensive experience in bioanalytical analyses to support discovery and pre-clinical drug metabolism studies utilizing state-of-the-art LC/MS/MS instruments. In addition, the Avista Pharma team has experience with metabolite identity (ID) from such studies (described above in Impurity Identification).

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Impurity Separation
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Isolation of impurities may be required for a variety of reasons, including as part of a structural elucidation project, generation of materials for use as reference standards and separation of racemic mixtures into enantiomers. Avista Pharma has preparative equipment with multiple modes of separation, including normal and... Show more »

Isolation of impurities may be required for a variety of reasons, including as part of a structural elucidation project, generation of materials for use as reference standards and separation of racemic mixtures into enantiomers. Avista Pharma has preparative equipment with multiple modes of separation, including normal and reverse phase High Performance Liquid Chromatography (HPLC) and Supercritical Fluid Chromatography (SFC), to enable isolation of materials, as necessary. The best-in-class Avista Pharma team has many years of experience with these techniques to enable rapid isolation in the most efficient possible manner.

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Material Testing Services
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Identification of materials often extends beyond chromatographic or Fourier transform infrared spectroscopy (FTIR) analysis. Knowledgeable staff at Avista Pharma have the capabilities to execute material and polymorphic form identification utilizing Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA) and... Show more »

Identification of materials often extends beyond chromatographic or Fourier transform infrared spectroscopy (FTIR) analysis. Knowledgeable staff at Avista Pharma have the capabilities to execute material and polymorphic form identification utilizing Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA) and X-Ray Powder Diffraction (XRPD). The capability to perform TGA-Gas Chromatography-Mass Spectrometry (TGA-GC-MS) is also available.

Particle Size Determination

Particle size is critical to ensuring materials maintain expected processing and performance characteristics. Avista Pharma is equipped with laser particle size (LPS) instrumentation to ensure materials are consistent from batch to batch. If further investigation is necessary, the capability to provide large population particle imaging with particle gallery and various size and shape results is available.

Elemental Impurities

Implementation of ICH Q3D and USP <232>/<233> Elemental Impurity guidelines is set for the first stage of implementation. Avista Pharma staff have extensive knowledge and experience providing consultation and analytical support to navigate and achieve compliance with the elemental impurity guidances. We can assist in developing a risk assessment strategy via documentation, analytical screening and method development/validation to achieve compliance. Analytical testing is performed using Microwave Plasma – Atomic Emission Spectrometry (MP-AES) and redundant Inductively Coupled Plasma – Mass Spectrometer (ICP-MS) instruments with microwave digestion available.

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Particle Analysis and Characterization
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Particle size is critical to ensuring materials maintain expected processing and performance characteristics. Avista Pharma is equipped with laser particle size (LPS) instrumentation to ensure materials are consistent from batch to batch. If further investigation is necessary, the capability to provide large population particle... Show more »

Particle size is critical to ensuring materials maintain expected processing and performance characteristics. Avista Pharma is equipped with laser particle size (LPS) instrumentation to ensure materials are consistent from batch to batch. If further investigation is necessary, the capability to provide large population particle imaging with particle gallery and various size and shape results is available.

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Structure Determination
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Structurally characterizing small amounts of material is a key step in solving many challenging hurdles encountered during pharmaceutical development in the laboratory and manufacturing.

Materials of interest include:

  • reaction side products produced during process development and scale up
  • impurities formed during... Show more »

Structurally characterizing small amounts of material is a key step in solving many challenging hurdles encountered during pharmaceutical development in the laboratory and manufacturing.

Materials of interest include:

  • reaction side products produced during process development and scale up
  • impurities formed during stability studies via API degradation or reaction with excipients
  • metabolites of APIs observed during clinical testing

The team at Avista Pharma Solutions has experience tackling all of these issues and a proven track record of identifying, isolating and characterizing these materials. Areas of expertise and capabilities include preparative and semi-preparative chromatography, mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy. The most difficult structure elucidation challenges require an integrated approach that utilizes these advanced analytical testing techniques in concert. Avista Pharma’s integrated team excels at tackling such problems efficiently and providing concise professional reports suitable for inclusion in regulatory filings.

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Process Consulting
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Avista Pharma’s process chemists have extensive experience in pharmaceutical process development (PD) research. Investment in PD research often reduces the cost of goods associated with an API through optimization or replacement of expensive and/or inefficient synthetic operations. If necessary, re-design of an entire... Show more »

Avista Pharma’s process chemists have extensive experience in pharmaceutical process development (PD) research. Investment in PD research often reduces the cost of goods associated with an API through optimization or replacement of expensive and/or inefficient synthetic operations. If necessary, re-design of an entire manufacturing route can be executed in order to facilitate material throughput in support of a development program. Avista Pharma strives to rapidly deliver innovative technologies to solve PD challenges and advance development programs. Our process research team works closely with the analytical research and development (ARD) team to integrate chemistry and analytical controls into the process at an early stage of the project.

Avista Pharma’s best-in-class services for Process Development Research include:

  • Discovery chemistry intermediates and analogs preparation from milligram to kilogram scale
  • Custom synthesis
  • Route discovery, selection and definition
  • Process improvement and optimization
  • Robustness and process limits testing
  • Synthesis of analytical reference standards
  • Metabolite, degradant and impurity synthesis
  • Reference standards and impurity qualification
  • Impurity isolation, identification and structure elucidation
  • Preparative chiral and achiral chromatography (LC, SFC)
  • pGTI identification and method development
  • Quality by Design (QbD) process evaluation
  • Statistical Design of Experiments (DOE)
  • Determination of critical process parameters (CPP) and critical quality attributes (CQA)
  • Process scale-up and demonstration
  • Solid state chemistry –salt selection, polymorph screening, amorphous dispersions, crystallization development
  • Hazard evaluation
  • Phase appropriate analytical method development
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Compound Synthesis
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Avista Pharma Solutions is driven by an established, committed and innovative team with specific strengths in custom synthesis, route scouting, process optimization, solid state chemistry, analytical development and cGMP manufacturing.

Avista Pharma Solutions provides research and process chemistry services to the chemical... Show more »

Avista Pharma Solutions is driven by an established, committed and innovative team with specific strengths in custom synthesis, route scouting, process optimization, solid state chemistry, analytical development and cGMP manufacturing.

Avista Pharma Solutions provides research and process chemistry services to the chemical community to support development programs from preclinical through commercial manufacturing. Avista Pharma has a proven track record of confronting and resolving challenges associated with the development of complex synthetic organic chemistry projects as well as providing process optimization expertise for challenging API development programs. Our multi-disciplinary team of scientists includes experienced personnel from a variety of big pharma research organizations. Expertise in cGMP manufacturing, together with operations out of a fully equipped, state-of-the-art laboratory, ensure that all projects are delivered in-full, on-time and with a high degree of quality. A dedicated project manager ensures execution of the full scope of work in each contract and full client satisfaction in all aspects of the project(s).

Avista Pharma’s best-in-class areas of synthetic expertise include:

  • Terpenoid glycosides
  • Carbohydrates
  • Glycolipids
  • Cyclic peptides
  • Biopolymers
  • Oxaboroles
  • Macrolides
  • Heterocycles
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Microbial Identification and Strain Typing
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Our unique identification laboratory has two 16 capillary Microseq™ genetic analyzers that allow increased throughput. We are experts in both fungi and environmental contaminants. Genetic analysis of the ribosomal RNA is accurate and validated. Libraries are maintained and periodically updated by the manufacturer. Determining the... Show more »

Our unique identification laboratory has two 16 capillary Microseq™ genetic analyzers that allow increased throughput. We are experts in both fungi and environmental contaminants. Genetic analysis of the ribosomal RNA is accurate and validated. Libraries are maintained and periodically updated by the manufacturer. Determining the correct genus and species is essential for developing a robust product and environmental surveillance program.

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Project and Process Management
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Biology
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Microbiology Services
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Microbiology Assays
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Chemistry and Materials
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Synthetic Chemistry
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Analytical Chemistry Services
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Purification Services
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Formulation Services
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Product Development, Testing, and Packaging
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Pharmacology & Toxicology
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Solid Dosage Formulation
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Chemical Stability Testing
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Chromatography
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Animal Models and Studies
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pH Measurement
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Antimicrobial Activity Testing
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Wet Chemical Analysis
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Bacterial Culture
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Particle Size Distribution
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Compound Purification
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Sample Recrystallization
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