Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015) (internal) and GMP (Spectralservice)
Pharmacopoeia:
EP 2.02.33
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015) (internal) and GMP (Spectralservice)
Pharmacopoeia:
EP 2.02.33
Therapeutic Modalities:
Biologics
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015) (Spectralservice) and GMP (Spectralservice)
Pharmacopoeia:
EP 07/2024:0333; EP 07/2024:0332; EP 07/2023:0828 USP: Monograph: Heparin Sodium ; USP: Monograph: Dalteparin Sodium; USP: Monograph: Polyoxyl 20 Cetostearyl Ether
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015) (internal) and GMP (Spectralservice)
Pharmacopoeia:
EP 2.02.33
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. monographs, Ph. Eur. 2.2.56, method I, physiological system
Therapeutic Modalities:
Biologics
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. monographs, Ph. Eur. 2.2.56, method I, Hydrolysate or physiological system
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
non-GMP (ISO 9001:2015)
Pharmacopoeia:
USP <211> Arsenic
Therapeutic Modalities:
Small Molecules
Development Phases:
Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
EP 2.4.16 or USP <733>
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. 2.2.22 / 2.2.23, USP <852>, Ph. Eur. 2.4.20, USP <233>
Therapeutic Modalities:
Biologics, Cell & Gene Therapies
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Therapeutic Modalities:
Biologics, Cell & Gene Therapies, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP, ISO 17025
Pharmacopoeia:
Ph. Eur. 2.6.14, USP <85>, JP 4.01, Ph. Eur. 5.1.10
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
Pharmacopoeia:
Ph. Eur. 2.9.26, Method II: The volumetric method, USP <846>, Method II: The volumetric method
Therapeutic Modalities:
Biologics, Small Molecules
Development Phases:
Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial
Quality Standard:
GMP and non-GMP (ISO 9001:2015)
