Contract Research Services (CRO)


Introduction

Our organization thrives on the advancement of medical, chemical, pharmaceutical, and biotechnological innovations. With years of experience in polymer R&D, we have the expertise to help you understand and integrate macromolecular chemistry to improve design, performance, and function of your products containing polymers in any industry.

Our services are used internationally with various sponsors and collaborators to develop and validate unique methods of analysis for the polymers used in their products. We assess the potential risks and variables by systematically testing the relevant factors and their effects on the polymer properties with rational experimental designs to answer key questions.

How We Work

1

Consultation with our scientists to identify problems, discuss objective, and understand needs.

2

Scope of work with estimate timelines and pricing.

3

Development and Approval of The Analytical Protocol and Procedures.

4

Study initiation and execution according to approved protocol.

5

Interim reports are shared with Study Sponsors throughout the study to ensure deadlines and objectives are on schedule and on budget.

6

Submission of final approved report. Completion of the study and archiving of all data.

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Industries Served

The PolyAnalytik team’s expertise in analytical testing provides a good foundation to build strong relationships with all our clients, including academia, industry, government, and life sciences. At PolyAnalytik, we foster a high level of scientific collaboration to expedite, strengthen, and advance innovation.

Our clients range from small, medium, or large organizations in various sectors including:

  • Biotech

  • Biomedical

  • Pharmaceutica

  • Oil and Gas

  • Renewable energy

  • Bioremediation

  • Environmental

  • Regulatory bodies

  • Food and Nutrition

  • Agricultural

  • Wastewater Treatment

  • Plastics and Resins (packaging, toys, everyday commodities)

  • Chemicals

  • Coatings and Adhesives

  • Electronics

  • Transportation and Construction

Services Offered

  • R&D projects

  • Product development and registration

  • Regulatory testing (in vivo and in vitro polymer Degradations, Aggregates Detection, Residual Monomer, Residual Solvent, etc)

  • QA/QC of Manufacturing (Dilute Solution Viscometry, Molecular Weight, Polydispersity Index, etc.)

  • NIST-traceable Certificates of Analysis

  • Lot Release Testing (Batch to Batch Variations, Stability, Shelf-Life)

  • Pharmacopeia testing

  • ASTM

  • Testing as per ISO Guidance Documents and Protocols

GPC/SEC Method Developments

Many organizations and institutions involved in developing new synthetic polymers/copolymers or new applications for existing synthetic polymers, natural polymers, and biopolymers often face challenges when characterizing their material or product.

Examples of challenges include:

  • polymer solubility

  • ionic charge

  • complex polymer chain microstructure

  • very high molecular weight

  • broad molecular weight distribution

  • polymer aggregation

  • polymer degradation, shelf-life, and stability

  • oligomeric composition

  • copolymer composition

  • complex multi-component composition of final product

  • unknown concentration of the target polymer

  • interference of other components with the target polymer etc.

PolyAnalytik addresses the unique challenges of specific applications to develop comprehensive and reliable GPC/SEC analytical methods to measure molecular properties of newly emerging or existing applications and polymers. Methods developed for a customer are transferable to their laboratory including GPC/SEC columns, standards, and comprehensive training of analytical staff.

Our team of experts communicates with customers to obtain necessary information including sample concentration, composition, chemistry, synthetic process, manufacturing process, and applications to define project objectives. A detailed work plan is formulated with clear objectives, estimated time and cost for each section of the project.

The work plan typically includes sample description and evaluation (e.g. solubility testing and chemical analysis), sample preparation (e.g. proposed extraction/purification procedures), GPC method development which includes determining optimal GPC conditions (e.g. mobile phase, flow rate, temperature, GPC columns, standards), and development of GPC analysis procedure for measurement of target molecular parameters (e.g. molecular weight, molecular weight distribution, intrinsic viscosity, chain conformation, copolymer composition, branching analysis, weight fraction analysis, concentration, etc.).

Many development projects include the development of extraction procedures for complex multi-component samples to analyze the targeted polymer. We have a broad range of experience dealing with synthetic polymers and copolymer, polymer-conjugated proteins, environmental samples, food formulations, biological samples, etc. For specific examples, please visit our library of Application Notes.

The cost of method development projects vary depending on the complexity and scale of the samples/applications.

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GPC/SEC Method Validations

All SEC/GPC analytical methods possess a certain degree of variation which can be influenced by various factors including: instrumentation (e.g. make and model of analytical instrument, specifications of different detectors), specifications of GPC column sets (e.g. dimensions, stationary phase, particle size, pore size, exclusion limit, and theoretical plate number), calibration and verification standards (NIST traceability or Pharmacopeia certification), standards and samples preparation (e.g. concentration, dissolution solvent composition, reagent grades, dissolution temperature and time, filtration), GPC conditions (e.g. mobile phase composition, reagent grades, flow rate, temperature), and analyst.

PolyAnalytik offers method validations to determine the accuracy, reproducibility, and degree of variation for molecular parameters measured using a wide range of GPC methods in different mobile phases including aqueous buffers and organic solvent/mixtures and system configurations include different type of detector used (e.g. refractive index, UV, light scattering, and viscometer).

The reproducibility and degree of variance attributed to the GPC method is examined for targeted molecular parameters such as molecular weight (MW), molecular weight distribution (polydispersity index, PDI), intrinsic viscosity, concentration, Mark-Houwink parameters (alpha, log K), and Weight Fractions of oligomers. The lowest detectable limit of the different detectors used in the GPC method is also often assessed as part of the validation study. This is of particular interest for projects requiring accurate quantification/concentration measurements of a polymer in very dilute solutions.

The cost of method validation studies vary depending on the GPC method conditions, the number of samples tested, and the number of independent runs requested by the customer (minimum of 3).

Medical Device Studies

The use of biocompatible, biostable or biodegradable polymers in medical applications has enabled the design of mechanically stable and functional implants with controlled drug release surfaces that have positive health outcomes for patients. These polymers have also enabled the design of targeted drug delivery mechanisms that find uses in many areas of research and current applications (e.g. gene therapy, stem cell research and therapy, scaffolds engineering, organ regeneration, regenerative medicines, cancer therapy, heart disease, implant scaffolds used in angioplasty).

For example, many polymers are used in medical devices and implants as biocompatible or biostable coatings to prevent foreign body response (FBR) which can lead to implant rejection. Some of these polymers are mixed with anti-inflammatory drugs to prevent FBR and promote healthy tissue regeneration.

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Project Types
Pharmaceutical, Biotech, Food & Agriculture

These contract research projects include (but are not limited to):

Biocompatibility Testing (as per ISO10993)

In vivo Polymer Degradation:

  • Entails development and validation of polymer extraction procedures from biological samples,

  • Determine polymer degradation (molecular weight reduction, percent mass loss) via validated GPC methods,

  • Determine mechanical properties of the degraded test samples.

In vitro Polymer Degradation (Accelerated and Real-Time)

  • Hydrolytic degradation

  • Oxidation

  • pH

  • Temperature

  • Enzyme degradations

Environmental Studies

The use of biodegradable polymers has become a popular area of research due to the promise of cleaner, safer, and renewable technologies. However, concerns arise when trying to properly understand the mechanism of degradation of your products in the environment (e.g. soil, seawater, oil flow back water, effect of storm events, temperature, humidity, winds, bacterial flora, microbiology, ecosystem).

The development of an analytical method is required when probing the chemical identity of degradation products present or persisting in the environment. Important factors such as polymer identity (polymer fractions, low molecular weight polymer chains, oligomers, monomers, aggregates), concentration, kinetics of degradation, mass loss monitoring, charge, structural changes etc. are considered when developing and validating an analytical method to ensure the highest accuracy and reproducibility of the results.

Examples of services we provide are:

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We are committed to assisting you with your polymer analysis needs

Our team of specialists will provide you with quality services and dependable analytic results in a timely manner.

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Have more questions? Contact us! 226-213-5213