GMP Production

Bachem’s manufacturing facilities in the U.S. and Switzerland comply with the Good Manufacturing Practice (GMP) standards of regulatory agencies such as the Food and Drug Administration (FDA) and the Swissmedic (Switzerland).

Our production plants are endowed with state-of-the-art equipment for solvent supply, peptide synthesis, purification and isolation of active ingredients and intermediates. All equipment and containment is GMP qualified and cleaning validated. Overlapping capacities and sizes of different equipment trains facilitate a smooth scale-up in case demand is increasing within the product life cycle.

Our highly motivated and skilled staff are eager to meet the individual needs of our customers despite demand uncertainties or technological challenges. Our recipe for success is a close working relationship with our clients. This helps to customize and schedule process development packages in order to meet ambitious timelines, to manufacture an excellent (i.e. phase-appropriate) quality product, and ensure process efficiency.

Watch the full video at the “CMC development” live area of Bachem360

GMP Production Capabilities:

Synthesis of peptides and oligonucleotides (“Upstream”)

Our production plants are equipped both with solution-phase synthesis reactors and with solid-phase synthesis reactors. Also a combination of the two techniques, often referred as “hybrid approach”, or modern Green Chemistry approaches such as Molecular Hiving™ can be run within our facilities. Simply ask our experts, what the best approach could be to make your product!

For a wide range of solution phase chemistries, we utilize reactors up to 8000 liters. For solid phase peptide synthesis (SPPS) we use reactors up to 1000 liters, with larger scale-up options currently under construction. In Bubendorf, a new large-scale peptide and oligonucleotide facility is being planned with reactor sizes up to 3000 liters.

For each type of GMP qualified equipment we have multiple independent production trains. For oligonucleotide synthesis we are using GMP-Qualified OligoPilot™ 100 and 400 synthesizers plus a large-scale synthesizer, with a capacity of up to 2 moles. Custom-made cleavage and deprotection equipment trains enables wide range of chemistries at all scales. Handling of large quantities of hazardous reagents is achieved in a closed and safe environment.

We balance the flexibility of key equipment, with various levels of automation, with increasing use of a Manufacturing Execution System (MES) and a process data historian. Processes are developed according the Quality by Design (QbD) approach, controlled via in-process controls (IPC) or process analytical technology (PAT).

Purification and isolation of peptides and oligonucleotides (“Downstream”)

Bachem is committed to the systematic expansion and modernization of its purification equipment in order to ensure the efficient production of ever-increasing amounts of bulk peptide and oligonucleotide pharmaceuticals.

Methods such as preparative high performance liquid chromatography in a badge (HPLC) or continuous mode (MCSGP – Multi-column Counter-current Solvent Gradient Purification), ion exchange (IEX), size-exclusion chromatography (SEC), and ultra-filtration (UF / TFF) are utilized for large scale purification campaigns. The equipment in place permits highly efficient or even continuous manufacturing of extremely pure products up to multi-kg quantities per lot.

For preparative HPLC, dynamic axial compression (DAC) stainless steel columns of up to 60 cm diameter both in batch and continuous mode are packed with the appropriate high performance silica separation phase. For low-pressure chromatography columns up to 80 cm diameter are available. Solvent delivery is ensured from eluent tank farms and containers.

The control of microbiological contamination is a prerequisite for API manufacturing. Class D (ISO 8) and C (ISO 7) clean rooms are supplied via HEPA-filtered, temperature and humidity controlled air, down-flow booths are used for minimizing microbial contamination and protecting operators. Highly active pharmaceutical ingredients are handled in integrated safety workbenches or flexible isolators reaching OEB level 4 (1-10 µg/m3).

Predefined physicochemical properties of the API can only be achieved by a carefully controlled isolation process. Besides precipitation and crystallization, lyophilization of intermediates and final API is a standard unit operation. On each site we have multiple lyophilizers in different sizes (up to 300 liters) located in clean rooms.

Small Molecule Manufacturing

Bachem has capabilities for the production of GMP small molecules at the site in Vionnaz. The following services are offered:

  • Process development
  • Chiral synthesis
  • Heterocyclic chemistry
  • Metal-catalyzed reactions
  • Hydrogenations
  • Oxidations and reductions using various reagents
  • Enzymatic reactions
  • High pressure reactions

What is GMP?

GMP stands for Good Manufacturing Practices. They are the practices required in order to conform to the guidelines recommended by the agencies that control the authorization and licensing of the manufactured products (e.g. FDA, EMA and Swiss Medic). The guidelines provide requirements that a manufacturer must meet to assure that their products are consistently high in quality.

A more detailed article on GMP can be found here.

What is Continuous Chromatography?

Continuous chromatography or Multi-column countercurrent solvent gradient purification (MSCGP) is HPLC, but differs in the fact that it is a fully automated system, using multiple columns and is loaded continuously. Continuous chromatography provides high yields of product without negative impact on purity and the solvent consumption is typically decreased, thus providing a greener chemistry.

For more information watch the video above or download our whitepaper here

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