Focusing on peptide synthesis technologies for the production of API's for the pharmaceutical industry, Novetide has developed a comprehensive technology platform enabling the production of various kinds of peptides..

R&D

Novetide's excellent R&D record means efficient development of your product that eventually will enable bring it market in the shortest time.
The search for optimal scalable synthetic routes and increased process productivity is our main task. It results in the industrial production of your peptide APIs.
We are continually upgrading our scientific and technological base, by identifying and applying breakthrough technologies. Contacts with leading academic institutes provide a stream of new, implementable technologies giving us that essential competitive advantage in terms of time to market, quality, pricing and support.
We respond rapidly and flexibly to changing market conditions and are committed to fulfill your expectations for timely and cost-efficient delivery.

Process development

Our dedication is to manufacture your product via an optimized and robust process. We know that time is crucial. Therefore we are committed to delivery in the shortest possible time.
Novetide process development pathway includes:

I. Development of the synthetic route using solution phase, solid phase, polymer supported or enzymatic methods, or combinations of all of these technologies. The optimized pathway for the developed synthetic route will be:

1. Efficient
2. Scalable
3. Robust
4. Able to produce high quality product
5. Environmentally friendly

II. Scale-up: While developing your product through its way to the market, scale-up of the process is taking place to yield a validated, robust, documented and optimized procedure.

III. Production: Our production plant works hand-in-glove with our R&D site. Our staff work both in development and in production, to enable smooth technology transfer. All of these activities are carried out under the close guidance of skilled chemists and engineers with the assistance of experienced technicians. Your process is monitored by our QC group using the appropriate analytical methods for in-process control and identification of by-products.

Down stream processing

Novetide does not concentrate on a specific technology but has expertise in several solid phase, liquid phase, and fragment condensation technologies. All steps used in process development are fully documented and can easily be scaled up to hundred kg. lots. After preparation of a qualification lot, validation lots and representative standards are prepared and used as the basis for scaling up to commercial batches. Novetide has expertise in large-scale synthesis technologies, large-scale HPLC purification and large-scale bulk lyophilization.

Analytical support and QC

A comprehensive set of validated analytical methods is offered in-house (incl. HPLC, TLC, GC, LC-MS and MS/MS, Amino Acid Analysis, microbiology, counter-ion analysis and residual solvents).

During process development, the process control flow-sheet, critical process parameters and in process control procedures are defined. The specifications for raw materials, intermediates, and for the final API are determined. A stability test is performed using Stability Indicating Method Protocol.

Regulatory affairs and Registration

We support your project during IND, registration and throughout the post-marketing phase. We strictly adhere to current guidelines and regulations and welcome your review and audits at any time. Our production site is regularly inspected by the FDA, and has an excellent track record. We offer our experience for the DMF preparation, and our expert guidance and support for meetings with regulatory authorities worldwide.

Customer Support

We fully understand the importance of decreasing development time and avoiding delays to market. Our comprehensive range of equipment and the latest, innovative technologies ensure that we will meet your manufacturing needs. We are committed to providing you with the best value at every stage of development. Our integrated Quality System ensures that your peptide will meet all of the regulatory requirements for manufacturing and documentation. You can rely on Novetide to be your quality partner for manufacturing your peptide API.