Development Pipelines

Bio-Synthesis provides several strategies for peptide synthesis to support projects of any size and requirement. We can handle peptide production from discovery, research grade, (multi-10 mg) non-GMP batches to multi-kg (and larger) GMP manufacturing needs. Our production chemists and analytical development team have extensive experience with a large variety of peptides and synthetic strategies at all scales, and we can help optimize your project by developing the most robust, economical manufacturing processes. Our production pipelines are:

Peptide library for Screening

Construction of peptide libraries for screening applications by using a systematic combination of different peptidies in large large number become a useful tool for: Optimize size and sequence (epitope mapping) Defines key structure actvity relationship Maixmize knowledge in a short time. Bio-Synthesis not only provide synthesis services, we routinely assist client with library design for an ideal screening solution. We has developed a rapid high-throughput parallel peptide synthesis platform equipped with PEPScan library design tools composed of six modules that can be efficiently used in epitope mapping and sequence optimization.

Custom, modified, and labelled peptides for Research and Development

This paramount service backed by strong peptide synthesis chemistry by using our the state of the art facilities. Once the correct sequences for your studies have been ascertained, Bio-Synthesis can synthesize peptid with whatever combination of labelling or synthesis options as may be required. Custom peptides from Bio-Sytnehsis are created in modern, automated synthesizers using mild Fmoc chemistry and advanced solid-phase techniques under the strictest quality procedures.

Immunoassay based products and services

Custom peptide plays a key role in: Immunological studies including eptiope mapping T cell stimulation Production of antibodies Study of antigen-antibody interaction and drug design. BSIs' antipeptide antisera services create antibodies, including antiphosphopeptide antibodies, for use in a variety of immunoassays. Affinity purification, conjugated peptides, "MAP" peptides with a range of peptide purities are all available. Clients can design their peptide by using our online peptide design software, or we can help with the design and choice of peptide antigens and offer a range of carriers for conjugation. Our polyclonal antibody production services are availble in a variety of species.

Pre-Clinical

Lead compound to an active pharmaceutical ingredient (API) by providing services including: Investigation of physcial properties, such as solubility or polymorphism, in consideration of various salts, purification methods and drying conditions Conjugations and chemical modifications to generate new chemical entities (NCES) Feasibility studies on synthesis routes and manufacturing process. Process develpment to establish an economical and scalable procedure. Develpment of Analytical Test Methods (ATM) for the API Chemical analysis and structure determination of peptides using MSD, HPLC, AAA, IR and more.

GMP peptides in clinical trials, Phase I-III and commercial application

Phase I Define specifications for the API, critical intermediates and key starting materials Development and qualification of cleaning procedures Scale-up production under appropriate GMP conditions for phase I clinical trials Development and qualification of ATM for critical intermediates Qualification of ATM for the API Set-up of preliminary stability studies on the API CMC preparation for IND/IMPD   Phase II Define specifications for the API, critical intermediates and key starting materials Development and qualification of cleaning procedure Scale-up production under appropriate GMP conditions for phase I clinical trials Development and qualification of ATM for critical intermediates Qualification of ATM for the API Set-up of preliminary stability studies on the API CMC preparation for IND/IMPD   Phase III Process validation Formal stability studies Update of CMC

Reguarlatory Filing and Commercial Launch

BSI provides complete assistance during drug development: stability studies of the active ingredient and/or the clinical trial material; assistance with formulation development; support with regulatory filings either in the form of a technical report (CTD format) which serves as the CMC section of the IND or complete preparation and maintenance of a DMF.