RESOURCES

Regulatory/Guidance Documents

GMP Regulations

Therapeutics (general)
	21 CFR 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
	21 CFR 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
	DIR. 2003/94/EC of 8-Oct-2003 Laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Cell & Tissue Based Products
	21 CFR 1271 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

Imaging Agents
	21 CFR 212 CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

Guidance Documents

Biosimilars
	EMA/CHMP/BWP/247713/2012 Guideline on similar biological medicinal products containing biotechnologyderived proteins as active substance: quality issues (revision 1)

Gene Therapy
	EMEA/273974/2005 NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS

Assay Validation
	Q2(R1) VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY

Protein Instability Following Transport or Storage on Dry Ice.
Nature Methods 10: 278–279, 2013

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Excerpt from: Formulation and Stabilization of Biotherapeutics MIT Professional Education
July 21-23, 2014

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	ExPASy: bioinformatics resource portal
	OnlineConversion: unit conversion tools
	Genetic Engineering & Biotechnology News
	Biocom: member driven / providing resources to science companies
	Formulation, Analysis, Stabilization and Delivery of Biotechnology-Based Products