PharmaNet Development Group offers a full range of services relevant to the clinical development of large-molecule products. These services include:

 

Phase I–IV programs
Bioequivalence studies for biosimilars
	Bioanalytical support for the development of protein therapeutics, immunochemistry, and cell-based assay, including:
	Immunogenicity assays
	Meso-scale assays
	Enzyme assays
	Neutralizing antibody assays
	Development of proprietary ELISAs
	Validation of commercial kits
Analytical structure elucidation, characterization, and similarity assessment
	Consulting with professionals who have extensive experience in biotechnology product development and can provide advice on topics covering the entire spectrum of development, including both early stage clinical trials and multi-site global trials in almost all therapeutic areas. These professionals include former senior-level FDA officials who have served on committees to develop guidance for large-molecule compounds

 

 

Experience

PharmaNet professionals offers experience in a variety of areas relevant to the development of biologic/biosimilar products, including:

 

	Clinical experience in non-traditional routes of administration, such as insulin clamp studies in diabetic patients
Biosimilars
	EPO and modified EPO
	G-CSF
	Amphotericin B liposome
	hGH (and IGF-1)
	PEG-Interferon alpha 2b
	Modified Interferon
Validated Biosimilar Assays
	Erythropoietin
	Interferon alpha 2b
	hGH
	IGF-1
Biosimilar Assays in Development
	Insulin
	C-peptide
	EPO in rat and dog
	Peg G-CSF in rat and monkey

 

For our complete list of validated assays, click here.

 

 

Consulting Expertise

Our consultants provide expertise to both large and small biotechnology companies, as well as to the biologic or biosimilar divisions at large pharmaceutical companies. Our consulting expertise covers:

 

Vaccines

Recombinant proteins

Blood products

Gene therapy

Monoclonal antibodies

Combination products

Second-generation biologics or “biobetters”

 

Our consulting work often begins at the discovery or pre-clinical stage, when strategic guidance is needed to select the product most likely to be approved. During the clinical phase, consultants provide guidance as to how a regulatory reviewer may approach the clinical results. Before or after regulatory meetings, our consultants assist clients in preparing to discuss critical issues with regulators and help them respond to issues brought up by the regulatory team.

 

In the CMC area, our consultants help clients evaluate product comparability, when to scale up or find another manufacturer, and how to evaluate risk and respond to it. Our consulting group can also provide expertise in auditing and compliance.