Category Archives: GMP Manufacturing

We need to quickly move forward with our novel therapeutic oligo. Can TriLink produce clinical grade material and quantities?

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Yes! For over 20 years, we’ve been industry leaders synthesizing high quality research and diagnostic grade material, especially difficult and unusual constructs. We combine our expertise with a state-of-the art GMP manufacturing facility to offer mRNA, oligonucleotide and small molecule therapeutic development and production services, tailored for your specific applications.

TriLink can ensure methods and materials are compatible with GMP manufacturing requirements from the start of your research project. From idea conception to early human trials, TriLink is an expert partner. We offer consultation on compound design, material grade, process development, scale up and cGMP production. TriLink delivers consistent quality API on schedule, regardless of the scale. Plus, TriLink provides supporting documentation to streamline the IND submission process and carry you through to clinical trials – making the process efficient and cost effective.

TriLink has successfully taken targets from small, research grade syntheses through to large scale cGMP batches, including upwards of 10 grams of mRNA therapeutic compounds. We offer a wide range of manufacturing scales enabling you to specify the exact amount of material required for IND-enabling tox studies and early phase clinical studies.

With nine dedicated GMP manufacturing suites and two support labs, TriLink has the agility to meet most timelines by implementing and managing multiple projects in parallel. Our PMP certified project management team will ensure your product is delivered on time and on budget. Open communication and regularly scheduled updates throughout the manufacturing process will keep you  apprised of progress.

We know drug development is complicated, leverage our experience to ensure your success.

Request a GMP Consultation today:

Which level of GMP do I need?

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This is a decision for your regulatory department. However, we can offer advice based on your specific circumstances if you are unsure. Often, you do not need as stringent a manufacturing system as you may first believe.

Can I get research grade material that is well documented, but not as expensive as GMP grade material?

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Yes! We find the costs of managing separate documentation systems (one for research grade material and one for GMP grade material) are more than the cost savings associated with the reduced documentation required for research grade materials. Therefore, at TriLink there’s no such thing as research grade material. All compounds are manufactured under a GMP system at comparable prices to research grade material from our competitors.

What do GMP, ISO and QSR mean, and how do they differ?

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GMP stands for Good Manufacturing Practices, and refers to a system of manufacturing that guarantees reproducibility of product quality to set specifications. cGMP is simply Current Good Manufacturing Practices and refers to compliance with current regulations. It can be considered redundant since to be GMP compliant you must comply with current GMP regulations anyways. 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 are compliant with ISO 9001.