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Address

250 Quade dr., Cary, NC-27513

©2019 by Biolink Life Sciences. All rights reserved.

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Pre-Formulation

Formulation Development

Analytical Method Development & Testing

 

Solutions & Services

Physical Characterization
Polymorph screening, hygroscopicity testing, particle size, shape, and
surface area, and flow properties testing 

Solubility Analysis
Solubilization studies, partition coefficient studies, dissolution studies,pH solubility profile, and pKa determination

Stability Analysis
Solid-state stability, solution-phase stability, and excipient compatibility studies 

Immediate release solid dosage prototype development

Tablets, capsules, powders, and multi-particulate

 

Technical services

Formulation & manufacturing processes consulting Scale-up / Technical transfer assistance Formulation optimization

Modified release prototype development

Tablets and/or multi-particulates beads

Liquid and Semi-solids prototype development

Solutions, suspensions and semi-solids

  • HPLC Analytical Method Development and Validation (i.e. assay/ related substances & dissolution)

  • Cleaning validation and Verification

  • Clinical Trial Support (i.e. method development & batch release)

  • Pharmacopoeia Testing of raw materials & finished products (USP/NF, EP, BP, JP, & Client Methods)

  • Elemental Analysis (C, H and N)

  • Liquid Chromatography-Mass spectrometry Services

  • Mass-spectrometry Services

  • Infrared Spectroscopy Services

  • UV spectroscopy Services

  • Proton NMR and Carbon-13 NMR services

  • Analysis of Cation and Anion by Ion-Chromatography services

  • Residual solvent Analysis

  • Gas Chromatography Services

  • Lyophilization of Small molecules and Biologics

  • IVRT (Franz Diffusion)

"FTE-based" approach in working with Biolink enables customers to submit a list of projects to be completed one after another without requiring individual quotes on every new or follow-up projects. Our experienced project team interacts with the customer's project management team via regular conference calls, daily emails and bi-weekly reports..  Biolink’s FTE-based projects range from Synthetic Chemistry, Process Chemistry, Library Design Synthesis as well as Medicinal Chemistry, to aid lead generation and lead optimization efforts.

All FTE based projects are executed under confidentiality agreements, and processed under US standard protocols. Our documentation process, archiving is done using secured network with controlled access. Our Quality and Confidentiality Systems are integrated to ensure utmost protection through imposition of stringent documentation and protection practices with intimate involvement of Quality Assurance personnel. We continuously monitor Laboratory Note Books, review of research and analytical data, tracking of issued data / documents and archival of all the data, hence ensuring complete confidentiality in all our processes and transactions.

  • Custom synthesis of new molecules (mg to kg scale)

  • Process development and scale-up

  • Medicinal Chemistry and Analog Library Synthesis

  • Route design for proprietary molecules Structural identification of metabolites & degradants

  • Synthesis of analogues (deuterated) &  metabolites

  •  Process impurities of API and/or degradants

  • Synthesis of stable isotope-labeled compounds as reference standards

  • Bio-conjugation of drugs, protein, dyes and PEG polymers

  • Technology transfer

  • Stability storage

  • Stability summary report generation

  • Stability indicating method development and validation

  • Release testing

  • Assay, impurity, dissolution, water content, and other testing of various formulations

  • Range of Stability Storage Conditions

  • 25°C/60% RH

  • 40°C/75% RH

  • 30°C/60% RH

  • 25°C/40% RH

  • 30°C/65% RH

  • 5°C

  • 30°C/75% RH