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Cephalosporin and Penicillins

Services
Cephalosporin and Penicillins

Commercial Manufacturing at NextPharma Berlin and Göttingen

Beta-lactam antibiotics require dedicated, segregated manufacturing facilities. Cross-contamination controls for penicillins and cephalosporins demand separate air-handling systems, dedicated equipment and full facility separation. NextPharma operates two purpose-built sites: NextPharma Berlin for penicillin beta-lactams and NextPharma Göttingen for cephalosporin beta-lactams, each covering development through to commercial supply and QP release. Both handle human and veterinary indications, including paediatric formulations.

01

Why Segregation Matters for Beta-Lactam Manufacturing

EU GMP and FDA requirements for beta-lactam antibiotics mandate dedicated facilities with controlled air-handling, equipment segregation and validated cross-contamination prevention. Penicillins and cephalosporins must be manufactured in separate dedicated areas, and penicillin cross-contamination controls apply across the entire production environment. Both NextPharma sites were designed, built and validated specifically for their antibiotic class, with dedicated air-handling, dedicated equipment and validated cross-contamination controls across the full production chain.

02

NextPharma Berlin: Penicillin Centre of Excellence

NextPharma Berlin is a dedicated site for penicillin beta-lactam antibiotics, covering human and veterinary use from development through to scale-up, validation, commercial manufacture, stability testing and market release.

Bulk production and primary packaging run in a humidity- and temperature-controlled climatic zone at no more than 20 °C and 20% RH, the conditions moisture-sensitive penicillins and amoxicillin/clavulanic acid combinations require. Manufacturing capabilities include:

  • Oral solid dose forms: powders for suspension in bottles; tablets and film-coated tablets; hard capsules.

  • Granulation, encapsulation, tabletting, aqueous and solvent-borne film coating

  • Glass and plastic bottles and blister packs

  • Secondary packaging with serialisation, tamper-evidence and Bollini

03

NextPharma Göttingen: Cephalosporin Centre of Excellence

The cephalosporin operation at NextPharma Göttingen runs in a dedicated GMP-compliant area, fully segregated from the adjacent oral solids and clinical trial activities. Contract manufacturing is available alongside a full suite of supporting services on the same site:

  1. Oral solid dose forms: powders for suspension in bottles; tablets and film-coated tablets; hard capsules; multiparticulate capsules

  2. Glass and plastic bottles and blister packs Pharmaceutical development: formulation, pilot- and production-scale scale-up, validation, stability batches, galenic optimisation and registration services

  3. Microbiology

  4. Contract analytics: method development, validation, stability testing and storage, QC and market release

NextPharma Göttingen also serves as NextPharma’s principal Clinical Trials Services site, which means cephalosporin programmes requiring clinical-stage supply can access that infrastructure without a site change.

04

From Feasibility to Commercial Supply

Both sites take a beta-lactam programme through the same defined sequence, within their dedicated area: 

  • Pre-formulation: API characterisation, moisture sensitivity and excipient compatibility 
  • Analytical development: method development, validation and transfer 
  • Formulation and galenic optimisation, including paediatric and veterinary presentations 
  • Process development and scale-up from pilot to production scale 
  • Clinical supplies: clinical-stage supply through NextPharma Göttingen, the group’s principal Clinical Trials Services site 
  • Industrialisation: registration batches, validation, stability testing, registration services and market release with QP release in-network 

 

 

Beta-lactam antibiotics can only be manufactured in facilities dedicated to their antibiotic class, and moisture-sensitive penicillins additionally require the humidity-controlled conditions NextPharma Berlin operates. Sites meeting both requirements are not widely available, which makes a mid-programme transfer more constrained than for a standard oral solid. At NextPharma Berlin and NextPharma Göttingen, development, scale-up, validation and commercial manufacture all take place inside the same dedicated area, so the process parameters and packaging configuration established during development carry into commercial batches without a change of facility, with QP release available in-network. 

Quality and Compliance

Site

Regulatory Coverage
Berlin EU GMP, FDA
Göttingen EU GMP, FDA, ANVISA ; regular inspections by Gewerbeaufsichtsamt Braunschweig; inspections by the Russian Ministry of Health and the authorities of Belarus and Kenya

Manufacturing at both sites meets the segregation, air-handling and equipment requirements that EU GMP and the FDA apply to beta-lactams, including penicillin cross-contamination controls.

Commercial sites network and capabilities

Commercial activities are supported by specialist centres of excellence across Europe, each aligned to specific technologies and dosage forms.

Berlin

EU Supply Security and Filing Pathway

Both sites sit inside the EU regulatory perimeter. Manufacturing within Europe keeps beta-lactam supply chains out of the logistical and regulatory complexity of non-EU sourcing, and supports a direct filing pathway for EU market products. QP release is available in-network at both sites, removing the need for a separate release partner. For the full range of oral solid and speciality manufacturing across the network, see the Commercial Manufacturing and Packaging hub.

Scope Your Beta-Lactam Programme

Beta-lactam projects are scoped by antibiotic class, dosage form, target markets and volume. Share your product details and regulatory requirements, and we will confirm the right site and connect you with the relevant manufacturing and development contacts.

Talk to our beta-lactam manufacturing team
Commercial Manufacturing & Packaging
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Share your API, dosage form strategy and clinical or commercial timelines with our development team. We will confirm technical fit, outline the development pathway and identify the relevant specialist sites for your programme.

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