UCB-Bioproducts - Contract Peptide Manufacturing Services - CROs

Early Development Support
Our new North Augusta, SC facility includes a dedicated Applications Lab for supporting early development efforts, during pre-clinical and early clinical development phases. All our resources are dedicated to provide you with the fastest, most efficient synthetic solution for manufacturing the API for your peptide, which includes the appropriate level of documentation and control. You will have full access to all relevant technologies, including solid-phase peptide synthesis as well as liquid-phase peptide synthesis, fragments condensation, non-natural peptide derivatives synthesis and all relevant purification tools. We also implement the appropriate tools for analytical characterization.
Transition to Feasibility Studies
Once you have selected your peptide candidate for drug development, UCB-Bioproducts is ready to provide feasibility services:
* ICH-compliant stability studies on early and initial demonstration batches
* FDA-compliant Structural Proof Analysis on demonstration samples to support release of first production batches
* Expert consultation on regulatory strategy to avoid delays to market
* Well documented procedures for easy transition to full cGMP
Process Development Services
UCB-Bioproducts has expertise in all the major peptide synthesis methods: solid phase, liquid phase, fragment condensation and methods for producing chemically modified peptides such as peptidomimetics and pseudopeptides. Once we work with you to decide the optimal method, we have an integrated three-step approach to Process Development:
Three-Step Approach to Process Development
ASSEMBLE
PURIFY
CHARACTERIZE
UCB-Bioproducts' Process Development Objectives
* Use a minimal protection strategy and scalable chemistry
* Identify and optimize a scalable purification process
* Fully document the peptide process development
* Proactively develop parallel processes for the chemistry and analytical control methods
* Extensively characterize process intermediates
Assembly Development - Chemical Synthesis
A typical chemical peptide synthesis program is comprised of two parallel activities to develop the assembly scheme: definition of the manufacturing process and development of the controls for the chemical reactions.
Manufacturing Process Definition
* Choice of reagents, protections and solvents
* Control of reaction conditions
* Yield of coupling/deprotection steps
* Prevention and control of side reactions
* Solubility and isolation of intermediates
Analytical Controls Development
* Monitoring of every step with HPLC, TLC, etc.
* Enantiomeric purity control
* Control of identity
* Identification and characterization of intermediates
Purification Development - Analytical Development:
A typical peptide purification program has four steps that include both purification and lyophilization:
* Development of the purification process
* Development of specific analytical monitoring methods
* Evaluation of the stability of faction during purification
* Development of a specific isolation process
Downstream Processing (DSP) Services
In order to provide the most efficient way to meet the specific purification and isolation requirements of each peptide, we maintain an extensive range of equipment. This includes low pressure and preparative-scale high-pressure liquid chromatography, suitable for ion-exchange or reverse-phase purification processes, in a wide range of scale including very high scale. Concentration and isolation equipment includes large-scale rotary evaporation, pilot to production-scale thin film evaporation, spray drying and small to very large-scale bulk freeze-drying capacity. All isolation equipment is operated within a controlled environment or within isolators and exclusive environment monitoring and controls are enforced.
Analytical Characterization
At the end of your peptide process development program, we will provide you with a demonstration sample. We will then perform a comprehensive Analytical Characterization Study to determine the identity and the quality of the synthetic product. A wide variety of studies may be undertaken, such as mass spectroscopy (electrospray MS, HPLC, MS, MS-MS), sequencing (Edman degradation or tandem mass spectroscopy), enantiomeric purity determination of the amino-acids in the completed peptide, structure elucidation by 1D or 2D proton NMR and peptide mapping whenever relevant. Important physico-chemical characteristics would also be documented early on, such as the hygroscopicity profile of the peptide under different conditions of relative humidity.
Comprehensive Quality Control
In process Quality Control and Analytical Development
From the beginning of your peptide project, process controls are built into the development of your peptide. A routine testing schedule is defined and applied to each production lot before final release. Our testing includes several identity tests (e.g. chromatographic identification against an authentic reference sample) and several purity tests (e.g. stability-indicating chromatographic tests, dosage of residual moisture, counter-ion, organic volatile impurities, bacterial endotoxin, etc.). Finally, we develop an assay to determine the actual peptide content. A comprehensive, lot specific Certificate of Analysis is provided with each shipment.
UCB-Bioproducts - North America
UCB Bioproducts, Inc.
1024 Dittman Court
North Augusta, SC 29842
United States
Tel. 1.415.640.5263
Fax. 1.415.449.3429