An engineering run (ER) is required for custom compounds before drafting a statement of work (SOW) for GMP production. The ER produces sufficient material for method development and characterization. Reaction conditions and parameters are evaluated during the ER with selective in-process sampling used to monitor and control impurity formation and removal.

• • Conducted at 1/4 to 1/10 scale of the anticipated GMP batch
• • Produces material for analytical method development and customer evaluation.
• • Unnecessary if material has been made in-house previously
• • Short term stability observations will support GMP expiration assignment

Compounds from our catalog can be manufactured under GMP conditions to support the clinical trials. GMP products are made to order, quoted upon request, and require advanced planning due to the complexity of quality requirements, documentation, and coordination. Lead times vary by product, scale, inventory of precursor, and customer requirements.

• • Quoted upon request and cannot be purchased online; not maintained in-stock
• • All GMP requests reviewed by a project manager with follow-up questions
• • Official quotations issued within 2 weeks
• • 10 week minimum lead time for manufacturing, drying, testing, and product release

Macrocyclics applies GMP controls to the final transformation of the synthetic chain for standard GMP packages. Synthetic precursors are manufactured in-house and approved by the Quality Unit. There are no USP methods for our precursors or products. All analytical methods are based on sound science and process knowledge.

• • Early discussions are essential to align timelines and ensure necessary preparations.

• • Lead times depend on precursor inventory and the manufacturing schedule
• • We can create customized analytical protocols and manufacturing conditions
• • A purchase order initiates SOW drafting and finalizes the manufacturing plan.

After a purchase order (PO) is received, the Macrocyclics project manager will draft the SOW.  The SOW serves as the official project charter and defines specific deliverables and responsibilities such as release specifications, stability program, packaging requirements, and shipping conditions. The SOW must be signed by both parties before GMP manufacturing can begin.

Upon project completion, Macrocyclics will issue an electronic copy of the final project report to the customer's designated point of contact. The official project report is securely stored as a hard copy at our facility to ensure long-term record retention and compliance. Stability data and technical reports will be incorporated to the report over time.

The final project report includes the following attachments:

• • Statement of Work
• • Raw Materials and Data Package
• • Certificates of Analysis, Origin, and Compliance
• • Shipping Information
• • Stability Data