Research Update
Unique Radiolabeled Oligonucleotides
TriLink specializes in challenging constructs such as oligonucleotides with numerous modifications, molecular beacons and multiple dye labeled probes. TriLink remains the most trusted supplier for many unique constructs, such as highly modified radiolabeled oligonucleotides.
We have 14 years of experience manufacturing 35S and 3H labeled oligonucleotides including RNA, duplexes, dimers/trimers, customer-supplied materials and oligonucleotides containing base modifications, chimeric sequences and phosphorylation. This expertise has been valuable for customers such as Isis Pharmaceuticals:
"We have always been impressed with TriLink's knowledgeable scientific staff and pleased with their quality of radiosynthesis product. TriLink consistently met our expectations and with much professionalism. For these reasons, TriLink has been our preferred vendor for radiosynthesis of many oligonucleotide development compounds for over 10 years. We hope to be working with them for many more years to come."
- Isis Pharmaceuticals, Inc.
We look forward to working with you on your next pharmacokinetic study.
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Technology Spotlight
Full Service Therapeutic Oligonucleotide Services
From discovery to the clinic the Avecia-TriLink Alliance is here to support your therapeutic oligonucleotide research. TriLink specializes in pre-clinical oligonucleotide synthesis, while Avecia is dedicated to manufacturing for clinical trials.
Our common technology and analytical platforms, specifications and close communication ensure a smooth transition to a clinical-level program. Our processes are harmonized to minimize the challenges and risks associated with scaling up. Contact us today to discuss your project.
Visit the Avecia-TriLink Alliance at TIDES in Boston, April 25-28 to enter to win a free oligonucleotide!
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Question of the Month
Q - What do GMP, ISO and QSR mean, and how do they differ?
A - GMP stands for Good Manufacturing Practices, and refers to a system of manufacturing that guarantees reproducibility of product quality to set specifications. The requirements differ depending on what type of product is being manufactured and whether it is for pharmaceutical or diagnostic purposes. ISO stands for International Organization for Standardization, which offers a standard for operating a firm from management through manufacturing. It is more encompassing than GMP. QSR stands for Quality Systems Regulation, which are GMP standards described by the FDA for the manufacture of products for the diagnostic industry. The ISO and QSR systems each describe specific GMP standards. The ISO system pays more attention to the management of the firm and places a number of reporting loops in the firm to ensure attention to issues. The QSR system is more focused on the manufacturing systems, and the validation of those systems. Although neither standard is required to maintain GMP facilities, it is essential that a firm satisfies the requirements of the client's quality system. Generally, this means conforming to ISO or QSR standards. Every product made at TriLink is manufactured under GMP. We also offer QSR, including dedicated manufacturing suites, and are compliant with ISO 9001:2008 and FDA 21CFR 820 regulation for ASR manufacturing.
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