Services

Analytical & Microbiological Services

A standalone analytical and microbiological service. Method development, validation, transfer, stability, release and QP release — available whether or not we manufacture your product.
Services
Analytical & Microbiological Services
A standalone analytical and microbiological service. Method development, validation, transfer, stability, release and QP release — available whether or not we manufacture your product.

Analytical and Microbiological Services: GMP Testing

NextPharma’s analytical and microbiological laboratories are available to you as a standalone contract testing service, or as an integrated part of a development or commercial manufacturing programme. 

The scope of analytical services covers method development, validation and transfer, physico-chemical analytics, non-sterile and sterile microbiology, stability testing, and CoA creation. Many clients use our laboratories for contract analytics alone — method transfer, ICH stability storage, and release testing. Where testing sits alongside a Pharmaceutical Development or Commercial Manufacturing and Packaging programme, testing, stability and release stay aligned to your batch timelines and regulatory milestones. 

 If you are a sponsor, development or quality lead running a programme that needs analytical support tied directly to it, this page maps our laboratory network, the tests we run for sterile and non-sterile products, our stability capacity, and how release works. All testing is performed to EMA, FDA, ANVISA and ICH requirements and to the relevant pharmacopoeia (EP, USP, BP, JP).

 

Our Laboratory Network and Centres of Excellence 

Every analytical-capable NextPharma site runs the analytical activity for its own dosage forms or analytical services are supported by other NextPharma centres of excellence. Across the network, three centres of excellence anchor specialist testing, so each product type is handled where the relevant expertise and equipment already exist. 

Centre of Excellence  Scope 
Bielefeld (Germany)  Analytical services and physico-chemical analytics: method development, validation, transfer, routine testing, investigations and stability testing 
Göttingen (Germany)  Non-sterile microbiology: validation, transfer and routine analysis for microbial limit testing, hygiene monitoring, and preservative efficacy testing 
Tampere (Finland)  Sterile microbiology: sterility, endotoxin and bioburden testing, drawing on established sterile product development and production experience 

 

Analytical Services: Method Development, Validation and Transfer

Bielefeld is the centre of excellence for analytical services, with all analytical-capable sites contributing testing for their own dosage forms. 

01

Analytical Testing

  • Raw materials (Ph. Eur. / USP / JP), finished products and stability samples 
  • Controlled drugs and narcotics, under licensed and secure handling 
  • Testing to pharmacopoeial and customer specifications 

02

Analytical Methods

  • Development of assay, dissolution, HPLC, GC and stability-indicating methods 
  • Troubleshooting and optimisation of existing methods 
  • Validation and revalidation: accuracy, precision, specificity, detection and quantitation limits, linearity, range, robustness, and system suitability 
  • Verification for raw materials 
  • Method transfer, including comparability studies where required 

03

Analytical Techniques

  • Dissolution: Ph. Eur. / USP apparatus 1 and 2 (paddle/basket) with UV online measurement; apparatus 3 (reciprocating cylinder) 
  • Chromatography: HPLC / UHPLC with DAD, FLD, ECD and RID; GC / HS-GC with FID; TLC 
  • Spectroscopy: AAS (flame and graphite tube) / AES; UV/VIS; FT-IR 
  • Physico-chemical and other: Karl Fischer titration (water determination); Franz cell (vertical diffusion) for semi-solids; density; refractive index; optical rotation; melting point; loss on drying; residue on ignition; friability; hardness; disintegration; bulk and tapped density; particle size distribution (sieve analysis) 

04

Investigations and Support

  • OOX and root-cause investigations, with comprehensive scientific reports 
  • Risk assessments for quality events, elemental impurities (ICH Q3D) and nitrosamines 
  • Statistical evaluation for process validation, comparative dissolution and stability studies 
  • Quality by Design support 

05

Microbiology and Sterility Testing 

Non-sterile microbiology is delivered at Göttingen, where NextPharma has provided GMP-compliant microbiological services for over 50 years. Sterile testing is delivered at Tampere, drawing on established sterile product development and production experience. Microbiological testing of raw materials, bulk and final products, and manufacturing environments provides the evidence needed to demonstrate product quality, process control, and compliance with international guidelines and GMP requirements. 

06

Stability Storage and Testing

For clients requiring ICH and customer-specific stability programmes, testing is delivered principally at Bielefeld, covering study design, storage, monitoring, analytical testing and documentation. Bielefeld provides approximately 476 m³ of walk-in ICH stability chambers, complemented by 15 variable climate cabinets, refrigerators and freezers, and flexible client-specific set-ups. All chambers are qualified and fully controlled, with 24-hour monitoring, alarming and emergency power management. 

Our facility maintains multiple climate-controlled zones to suit different storage requirements. Standard conditions at 25°C and 60% relative humidity provide the largest capacity across three chambers (225 m³), whilst temperatures of 25°C with 40% relative humidity offer 85 m³ specifically for liquids in semipermeable containers. For warmer environments, we provide 20 m³ of storage at 30°C and 35% humidity, along with larger capacities of 73 m³ and 40 m³ at 30°C with 65% and 75% humidity respectively, designated as Zone IVa and IVb. For accelerated stability testing at the most demanding conditions—40°C with 75% relative humidity—we maintain 33 m³ of dedicated storage space.

Additional conditions are available on request, including 15 variable climate cabinets (e.g. 18 °C / 55% r.h., 21 °C / 45% r.h., up to 60 °C / 75% r.h.), photostability studies per ICH Q1B option 2, refrigerators and freezers at 2 to 8 °C, -20 °C and -80 °C, and cycle studies such as freeze-thaw. 

Qualified Person (QP) Release 

QP product release is available network-wide through the NextPharma QP team. Scope includes EU release testing of finished drug products, batch record review, market release for the EU, and audits of drug-product manufacturers. 

Development network and site capabilities

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

Berlin

Discuss How Analytical Fits Into Your Programme

Analytical, microbiological, stability and release work is scoped alongside your development or manufacturing plan. Share your dosage form, testing needs and timelines, and we will confirm technical fit and identify the relevant laboratory and named contacts for your programme. 

Talk to our analytical and microbiological services team 

Get in touch
Discuss your Pharmaceutical Development programme
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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