Find a contract manufacturer (CMO) or custom synthesis (CDMO) focused on the the production of large scale (multi-gram) peptide APIs using technologies like solid-phase or liquid-phase synthesis. Some CMOs also offer capabilities to develop recombinant peptides and protein products using microbial expression systems. Find proven strategic contract manufacturing partners who appreciate the differentiation that solid-phase synthesis and solution-phase synthesis. Solid phase synthesis offers the benefits of shorter process development and manufacturing time with greater cost efficiency at small to medium-scale production, but also remains competitive for larger-scale processes and for producing longer sequences and more complex peptides with elaborate side chains. Solution-phase synthesis on the other hand may be advantageous as product quantities increase. The key is to optimize process development and achieve highly efficient conversion at every amino acid coupling to achieve high-purity custom peptide synthesis and minimize the demands on downstream processing. Ensure that your CMO/CDMO offers cost analysis, project review, R & D process optimization and detailed qualification reports all stages of large scale peptide production. Utilize state of the art proprietary manufacturing technologies, with a full array of services to take your drug substance project from pre-clinical to commercial scale. Ensure that your contract manufacturer (CMO) or custom synthesis (CDMO) organization applies the Quality by Design (QbD) in the production steps for the manufacture of your peptide API. This compels them to selectively characterize the steps requiring a design space. Have the CMO/CDMO focus attention on critical process steps such as cleavage-deprotection, oxidation, purification, isolation & lyophilization and make sure the corresponding critical parameters are thoroughly challenged. Solid Phase Peptide Synthesis assembly requires further attention for design space as it is necessary to employ PAT on line and defining Quality Attributes of a Process. Although the Critical Quality Attributes of the peptide APIs have the most prominent place when designing a process, it is not sufficient to design a process only with the CQAs in mind. The scope of the quality concept has to be expanded to encompass all quality attributes of a process, which are: Critical Quality Attributes of the product; Yield; Throughput (e.g. kg/day); Costs; Robustness (e.g. scalability, reproducibility, lack of deviations, out of specifications, out of trends, reprocesses, reworks etc).

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Bachem has the capacity to manufacture peptide APIs from gram scale up to annual quantities of hundreds of kilograms and small molecules APIs from gram scale up to annual quantities of tens of tons.

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AMRI's expert scientists offer crystallization screening using a variety of crystallization techniques. They conduct initial screening on a small scale using various vapor diffusion techniques and batch crystallization techniques

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ScinoPharm provides comprehensive peptide synthesis technologies with full analytical and regulatory support.

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Carbogen Amcis SAS located in Riom, France, focuses on the development and manufacturing of formulation dosages, aseptic filling, and lyophilization of small-molecule APIs, highly-potent APIs and biologics.

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Cook Pharmacia's biologics manufacturing group at Cook Pharmica has highly experienced staff who work closely with the development group to ensure scalability to full CGMP production.

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As a pioneer in the peptide industry, Bachem has the expertise and knowledge base of more than 45 years you can rely on to produce from simple peptides to most complex and challenging molecules.

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We offer dedicated solutions for proteins, (high-value) small molecules and microorganisms for applications in pharmaceutical, food, feed and other bio-industrial markets. Our facility is both FDA and EMA (Pharmaceutical cGMP) approved.

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Our 1,700 square meter development laboratories and pilot plants are active in: Protein purification.

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KriSan Biotech has the capability to offer custom synthesis of peptides via solution phase or solid phase synthesis in few grams to hundred grams scale.

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Neuland’s peptide synthesis services include production of peptides from milligrams to multi-kilogram scale by standard sequential chemical peptide syntheses and segment condensation strategies.

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State-of-the-art analytical equipment and a small Pilot Plant to support the development programmes. The R&D Department is approved by the Department of Scientific and Industrial Research (DSIR), Ministry of Science and Technology, Govt. Of India.

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Synthesis of APIs, NCEs, & Other Services

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Dalton can provide material in a range of peptide purity from 70-98%. Mass spectrometry is used to verify the mass of the peptide.

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Pfanstiehl has vast experience in cGMP synthesis of Peptides

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At Grace we have scaled up over 150 peptide fragments ranging in scale from 1-500 Kg/batch and in lengths from 2-16 amino acids by solution phase chemistry.

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Using our broad platform in chiral technology, we have scaled up over 350 specialty amino acid derivatives ranging on scales from grams to low MT levels.