Alderley Analytical Partners

Biopharmaspec logo v2

BioPharmaSpec is an independent analytical research laboratory (CRO), specialising in Discovery, Early Phase and Pre-clinical characterisation and testing of Biopharmaceutical Products.

We help our clients get their biopharmaceutical products into clinical trials more cost effectively and quickly.

Our analytical data and support can help you choose the best cell clone for producing your biopharmaceutical product, characterise materials to define structure and physico-chemical properties, provide batch to batch comparisons and allow solid development decisions to be made based on quality analytical data and experience.

Using state-of-the-art Chromatographic and Mass Spectrometric instrumentation and methods, BiopharmaSpec applies its expertise built up over 45 years of pioneering academic and industrial Biopolymer Research to assist our Clients in a number of analytical areas including, Proteomics and Glycoproteomics, De Novo Protein Sequencing, Peptide and Glycopeptide Mapping, Disulphide Bridge Assignment, Carbohydrate Analysis, Biomarker Discovery and Structure Elucidation. The analytical data generated is backed up by consultancy and advice as an integral part of the development of your product.

Our combined experience includes structural characterisation and physico-chemical analysis of recombinant biopharmaceuticals including monoclonal antibodies and associated products, Antibody Drug Conjugates (ADCs) and blood circulating hormones.

For more information please visit the BioPharmaSpec website at www.biopharmaspec.com

Please mention Alderley Analytical when you get in touch, Thank You.

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KinetAssist logo

KinetAssist has extensive pharmacokinetic experience in the Pharmaceutical Industry and Contract Research, specializing in toxicokinetics, deconvolution and Phase I clinical PK support. KinetAssist has been operating for over 10 years. 

Pharmacokinetic analyses are undertaken in a GLP-compliant facility using WinNonlin Phoenix . Analysis and reporting is carried out within a fully audited Quality Management System compatible with OECD GLP (Good Laboratory Practice) and ICH GCP (Good Clinical Practice).

Scaling to man

Scaling pharmacokinetic parameters (e.g. intrinsic clearance) from in vitro studies (human hepatocytes/microsomes) to those in man. Allometric scaling to predict pharmacokinetic parameters in man from animal studies.

Deconvolution

Deconvolution is a procedure by which the input (absorption) process of a compound following various routes of administration (e.g., oral, inhalation and ocular) is dynamically characterised.

First-in-man

Extensive expertise in supporting first-into-man studies including pharmacokinetically-guided dose escalation.

Pharmacokinetic/Pharmacodynamic modelling

Experience in fitting logistic, Emax, inhibitory and direct-response models, including the development of effect-distribution models using link models and also simultaneous fitting of concentration-effect data.

Protocol design/Report writing

Consultation services on experimental design and clinical Phase I/II protocols. Generation of Pharmacokinetic Analysis Plans and concise, comprehensive reports of high quality that integrate PK, PD and associated statistical analysis.

For more information please visit www.kinetassist.com

Please mention Alderley Analytical when you get in touch, Thank You.

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Consult2Deliver Logo Final

Consult2deliver limited provide innovative yet pragmatic clinical and regulatory solutions for existing and new products in the pharmaceutical and healthcare sectors.  This is based upon our core expertise in pharmacokinetics, clinical pharmacology and regulatory affairs.

Using our extensive experience we can design, analyse and report your pharmacokinetic studies so that they provide clarity around their impact on future drug development. We use industry standard software (Phoenix™ WinNonlin®) to aid our fully audited non-compartmental, deconvolution and pharmacokinetic/pharmacodynamic (PK/PD) analyses.  We  have applied our expertise to address the following challenges:

 

 

For more information please visit our website at www.consult2deliver.co.uk

Please mention Alderley Analytical when you get in touch, Thank You.

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