Phase appropriate capabilities for analytical method development, optimization and validation
We provide support for the development or establishment of product-specific analytical methods, evaluation of generic and compendial methods, if applicable. Benefit from access to our analytical expertise, including a wide range of testing capabilities for a variety of microbial derived products. Our analytical experience is applied to support a range of methods including:
- HPLC & UPLC systems with a variety of detectors available, such asUV, DAD, CAD, MALS, Fluorescence
- Immunoassays – ELISA (titer, HCP, potency) with automated high-throughput robotics
- High sensitivity protein-PCR (ProteinSEQ™)
- High throughput screening (TECAN Freedom Evo)
- Protein content (BCA, Bradford, Lowry)
- qPCR, Picogreen and/or threshold
- SDS-PAGE and western blotting
- UV/VIS and slope spectroscopy
- Traditional approach on MTPs
- Bioburden and endotoxin
- CE-SDS, CZE, cIEF
- Fragment analyzer
- General compendial methods
Phase appropriate capabilities for analytical method validation and verification of compendial methods to support batch release
To allow for phase-appropriate batch release the following activities take place in our centralized QC services after method establishment in the microbial analytical development services:
Preparation:
- Evaluation of Lonza’s platform and compendial methods
- Formal transfer of product-specific analytical methods
- Verification and validation of analytical methods
- Development of analytical methods
Manufacturing:
- Environmental and clean utilities monitoring
- Raw material testing
- In-process testing
- Drug Substance release testing
- Drug Product release testing
The QC method portfolio includes methods in support of the following read-outs as in process sample or release testing and is aligned with analytical development services:
- Compendial methods, such as bioburden, endotoxin,
- Purity methods, such as HPLC, CE-SDS, CZE, iCIEF
- Impurity methods, to quantify residual HCP, genomic DNA or other process related impurities
- Content and purity such as HPLC methods, protein concentration by UV or other methods and potency by ELISA or cell-based assays
- The data systems applied in support of batch testing include document management, chromatography read-out, titration, environmental monitoring, sample management, instrumentation maintenance, lab execution systems and ERP.
Phase appropriate services for stability studies, analytical bridging and support of process characterization
In addition to batch release testing, stability studies can be supported as follows in our QC laboratories:
- GMP protocoled
- Range of container types
- Agitation & photostability testing
- Reference standard qualification and characterization
- Storage conditions as per ICH guideline:
- -65 °C and below
- -40 °C o -20 ± 5 °C
- +5 ± 3 °C
- +25 ± 2 °C / 60 ± 5 % relative humidity (RH)
- +30 ± 2 °C / 65 ± 5 % RH
- +40 ± 2 °C/ not more than 25 % RH and +40 ± 2 °C/ 75 ± 5 % RH
Our locations
Location where this service is provided
Visp, Switzerland
Founded in 1897, Lonza today is a dedicated strategic manufacturing partner to the healthcare industry, working with customers in the pharma, biotech and nutrition markets. Visp remains our largest site in a global network of more than 30 sites and one of the most significant for research and development and manufacturing.
Our Visp site is a complex of industry-leading facilities specializing in the development and manufacture of products for pharmaceutical applications including mammalian and microbial biopharmaceuticals, small molecules, highly potent APIs, peptides and bioconjugates including antibody-drug conjugates (ADCs). It is also home to our Ibex® Solutions pioneering services offering. Ibex® Solutions enables customers to accelerate their path throughout the complete biopharmaceutical lifecycle - from preclinical to commercial stages, from drug substance to drug product, all in one location.
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