At CD Formulation, we excel in the pilot-scale production of transdermal formulations, ensuring a seamless and efficient scale-up process. With advanced facilities, a highly skilled team, and extensive expertise in transdermal systems, we are a trusted partner for pharmaceutical companies and researchers. Our streamlined approach bridges the gap between small-scale research and full-scale manufacturing.

Introduction to Pilot Scale-up for Transdermal Formulations

The pilot scale-up of drug production is a process study carried out under the condition of simulating industrial production after the small-scale production process is opened up in the laboratory, to verify the feasibility of the original process after the scale-up production and ensure the consistency of the process during research and development and production. The pilot scale-up is not only a simple scale-up, but also a comprehensive verification, review, and improvement of the laboratory process to ensure it is suitable for industrial production. A pilot scale is the only way from drug research and development to production, and it is also an effective measure to reduce the risk of industrialization. Through pilot scale, necessary experience and test data can be accumulated to provide a design basis and guarantee for industrial production. At the same time, the pilot scale can also help find and solve possible problems in the production process and improve production efficiency and product quality.

Comprehensive Pilot Scale-up Services We Offer

We have the world's leading process scale-up production capacity, the workshop is built by GMP requirements, and each function has a complete and reasonable layout, to meet the needs of drug research and development and pilot production. The following production services can be provided:

• Sample production for drug feasibility studies, process development, and early customer development (e.g. early toxicological or pharmacokinetic studies).
• Toxicological sample production, support new drug clinical trial application (IND), and GMP scale-up production process evaluation.
• Support process scale-up and GMP production, including optimization of production scale-up strategies, risk assessment, and simulation of final GMP production conditions.
• Support sample production for later process characterization.
• All kinds of transdermal formulations are produced under GMP conditions.

Sterile Pilot Production Platform

• Batch: 5000 stickers/batch, 1 batch /2 days
• Non-terminal sterilization production process, equipped with C-level preparation area, B-level background A-level area, cRABS+ online sterilization system
• Automatic aseptic production line (until the aseptic inner packaging is completed)
• Sterile microneedle preparation raw materials, intermediate products and finished products release testing laboratory

Pilot Production Facilities

To guarantee the production of all kinds of products, CD Formulation is equipped with the most advanced laboratories and facilities to provide quality assurance for your transdermal formulations. Including but not limited to the following equipment:

• Ointment filling and sealing machine
• Vacuum emulsifier
• Filling capping machine

Innovative Technologies for Transdermal Formulation Scale-Up

Innovation in topical drug delivery formulations

• Medical aerosols
• Microsponges
• Lecithin organogels

Innovation in solid transdermal formulations

• Crystalline reservoir technology
• Gel matrix adhesive system
• DOT solid transdermal system
• Quantitative transdermal spray

Why Choose CD Formulation for Pilot-Scale Production?

• Cutting-Edge Equipment and Technology: Our facility is equipped with the latest technology, including advanced mixing, coating, drying, and cutting machinery designed specifically for transdermal formulation production. We guarantee uniformity, precision, and scalability in every batch.
• Experienced Scientists and Engineers: Our team knows transdermal drug delivery well. We guide you through each scale-up step for project success.
• Comprehensive Scale-Up Services: From refining formulations to validating processes, we offer tailored end-to-end services. Your transdermal patch will work well at larger scales, with no drop in quality or effectiveness.
• Quality Assurance and Compliance: We follow strict GMP. All pilot batches meet top quality, consistency, and regulatory standards. Our documents and validations meet agency requirements.

With years of experience in developing and scaling up transdermal formulations across diverse therapeutic areas, CD Formulation leverages state-of-the-art equipment and innovative technologies to ensure consistent, high-quality, and scalable production. Our pilot-scale production services provide comprehensive verification, review, and optimization of laboratory processes, ensuring their suitability for industrial production. Contact us to discuss how we can support your transdermal formulation project from the lab to the market. Our team will respond to your inquiry within three business days.