The Swiss CDMO landscape

What is a CDMO, and why is Switzerland strong here?

A CDMO takes on development and manufacturing for third parties, from process development through validation to commercial batches. Switzerland is disproportionately strong here because chemical competence, a long GMP track record and a quality reputation combine in a way that makes customers willing to pay a premium.

The root is the fine chemicals and dye industry of Basel and Aargau. Synthesis competence for intermediates became competence in active ingredients; from the 1990s the large groups divested or carved out plants, and those plants became independent contract manufacturers with existing equipment and experienced teams.

High labour costs act as a filter. Simple volume chemistry is cheaper in India or China; what stays in Switzerland are high-value steps: highly potent actives, peptides, oligonucleotides, sterile filling, complex crystallisations and processes where a failure costs more than the manufacturing premium.

The regulator adds to it. Swissmedic is a PIC/S member and Swiss GMP certificates are broadly accepted internationally. For a customer who wants to enter a site into an FDA or EMA dossier, an inspected Swiss site is an argument that lowers audit cost and timing risk.

What are the segments, and who does what?

The landscape splits into seven segments: small molecule active ingredients, highly potent and controlled substances, peptides and oligonucleotides, biologics including cell and gene therapy, sterile filling, finished dosage forms with packaging, plus analytics and quality control as a service field of its own.

In small molecule actives the references are Lonza in Visp, Siegfried in Zofingen and Évionnaz, and Dottikon Exclusive Synthesis in Dottikon; CordenPharma in Muttenz and HAS Healthcare Advanced Synthesis in Biasca serve highly potent and demanding chemistry. Bachem in Bubendorf and Vionnaz is one of the world's leading suppliers of GMP peptides and oligonucleotides.

In biologics and cell therapy Lonza is the large name, with cell culture and vector capacity in Visp and Basel. ten23 health in Basel specialises in formulation and sterile manufacturing of biologics, swissfillon in Visp in aseptic filling of vials and prefilled syringes for clinical and commercial quantities.

Cerbios-Pharma near Lugano combines chemical and biotechnological active ingredients with analytical services. Finished dosage forms, blisters, serialisation and release testing are covered by Siegfried, by Lonza in Stein and by independent testing laboratories that take on quality control for smaller authorisation holders.

How does a CDMO relationship work commercially?

The sequence is standardised: RFI, then an RFQ with specification and volume forecast, feasibility, technology transfer, validation batches, commercial supply. Three documents hang off it: a development or transfer agreement, a quality agreement, and a supply agreement with volumes, prices and term.

The quality agreement is the core and does not belong in an annex. It allocates responsibility: who tests, who releases, who decides on deviations, who notifies changes how far in advance, who keeps retention samples, how complaints are handled, and what audit rights the customer has at what frequency.

Commercially, campaign logic and minimum quantities set the price. Plants run in campaigns, not continuously; a customer taking small volumes pays a minimum order quantity, changeover costs or a reservation fee for committed capacity. Depending on the asset, slots are allocated six to eighteen months ahead.

The audit interface is not a side issue. The customer remains responsible for qualifying its supplier, runs regular audits and must be able to produce the contractor's documentation during an inspection by Swissmedic or a foreign authority.

• RFI and RFQ with specification, volume forecast, timeline and regulatory target market
• Feasibility and technology transfer with a transfer protocol, risk analysis and validation plan
• Quality agreement covering release rules, change notification periods, deviation process and audit rights
• Supply agreement with minimum order quantities, price tiers, campaign planning and notice periods
• Capacity reservation and slot planning, six to eighteen months of lead time depending on the asset

What stays with the customer, and what licences does the CDMO need?

The marketing authorisation always stays with the authorisation holder. The CDMO is a named manufacturing site in the dossier, so a change or an addition is a variation that has to be notified to Swissmedic or submitted for approval under the Therapeutic Products Act (HMG) and the Ordinance on Medicinal Products.

In practice that means a site change is a project, not an order. Technology transfer, comparability data, stability data where needed and the variation run in parallel; for a sterile process, twelve to twenty-four months from decision to the first released commercial batch is a realistic assumption.

The contractor itself needs an establishment licence from Swissmedic under the HMG and the Medicinal Products Licensing Ordinance (AMBV, SR 812.212.1), a responsible person with technical qualifications and, for export into the EU, a valid GMP certificate. Licence holders and certificates are publicly visible in the SwissGMDP database.

Cost planning relies on experience, not on list prices. Development and transfer projects often sit in the mid six figures, validation batches are invoiced separately, and unit costs only fall with volume. A customer needing small quantities pays a multiple per unit of what a large customer pays.

• The authorisation holder stays responsible for the authorisation, market release and pharmacovigilance
• The CDMO is a named manufacturing site in the dossier, and every change is a variation at Swissmedic
• Establishment licence under the HMG and the AMBV (SR 812.212.1) plus a responsible person with technical qualifications
• Check the GMP certificate and inspection history, both publicly visible via SwissGMDP
• Budget twelve to twenty-four months of lead time for a site change, realistically

How do you build a shortlist that holds?

A shortlist comes out of three filters rather than reference lists: technological fit to your process, capacity available in the window you need, and an inspection history that supports your target market. Everything else, price included, is only worth negotiating afterwards.

Ask about capacity early, not about prices. An excellent provider without a free slot is not a provider for your project. Ask for asset utilisation, planned investment, the batch sizes of the existing equipment and a straight answer on how your product fits into an ongoing campaign plan.

Test the interface, not only the plant. Who is your project manager, how many customers does that person carry, how fast does a deviation report reach you, and what language do quality assurance and regulatory speak? Two thirds of the problems in contract relationships are communication problems, not technical ones.

1. Write the requirements down: process, batch size, specification, target markets, timeline
2. Build the longlist by technology rather than by name recognition, segment by segment
3. Ask about capacity and slot availability in your window before discussing price
4. Check the licence and GMP status: establishment licence, GMP certificate, inspection history via SwissGMDP
5. Run a technical audit on site, focused on deviation management and data integrity
6. Negotiate the quality agreement and the supply agreement in parallel, including minimum quantities and reservation fees
7. Plan the transfer project and the Swissmedic variation together from the start, not one after the other