Contract manufacture
Through its exclusive relationship with Nova
Laboratories Ltd., Mercia Pharma provides access
to a dedicated, fully compliant GMP facility in Wigston,
UK. We have expertise in GMP-compliant, aseptic manufacture
of pyrogen-free immunotherapeutics including therapeutic
vaccines and component products. We get involved in
our customer’s projects and work with them to
understand their specific needs, and tailor specialist
services to match the project as it evolves.
Specialities
| |
Therapeutic vaccines. |
| |
Conjugated protein and peptide-based
antigens. |
| |
Adjuvant systems. |
| |
Immunogenic formulations. |
Facilities
and expertise
| |
Fully
validated, regulatory approved 2000 m2
manufacturing facility, including multiple clean
rooms and isolators (class 100/class A and B); preparation
areas (class 10,000 /class C); storage areas (class
100,000/classD). |
| |
State
of the art containment technology using multiple
4 to 14 glove gassed-isolators and technology for
containment and aseptic handling of complex, apyrogenic,
pharmaceutical formulations. |
| |
Analytical
testing, including:
|
| |
• |
Chemical:
HPLC, GC, Karl Fisher, SDS/IEF PAGE, ELISA, IR,
UV/VIS spectrophotometry, amino acid analysis, mass
spec. |
| |
• |
Physical:
Laser particle sizing and particle size distribution,
viscosity, density, conductivity, video microscopy. |
| |
• |
Microbiological:
Sterility, microbial burden, endotoxin. |
| |
• |
Immunological:
Immunogenicity and immunopotency testing. |
Services
| |
GMP-compliant, aseptic, manufacture
from development through clinical testing to full
commercial scale. |
| |
Formulation process and regulatory
expertise can be provided where required to support
product development, process optimization, scale
up, validation and commercial manufacture. |
| |
Analytical testing, methods transfer,
development and validation for in-process and release
testing of products are available on site in GMP-compliant
facilities. |
| |
Stability testing of products
and components can be undertaken. |
| |
Clinical Trials Supply Chain Management
can be provided, including: product storage, labelling,
randomization, distribution and reconciliation. |
| |
Qualified Persons on staff for
release of clinical trials and commercial supplies
for use in Europe. |
Manufacturing
Licenses and Experience
| |
Nova
Laboratories, Ltd., Wigston, U.K. GMP Facility |
| |
Full (MHRA, UK) Manufacturer’s
License for commercial supplies. |
| |
Investigational Medicinal Products
License (IMP) (European Clinical Trials Directive
2001/20/EC). |
| |
ISO9001: 2000 registration. |
| |
ISO13485:2003 registration. |
|
