Expanded GXP compliance increases Concept's breadth of services

9 Feb 2018

Successful MHRA inspection at Dundee site confirms GLP accreditation for in vitro safety studies and bioanalysis.

Concept Life Sciences has completed the first phase of its GXP compliance plan, achieving GLP (good laboratory practice) accreditation of its Dundee site for in vitro safety studies and bioanalysis.

Expanded GXP compliance increases Concept's breadth of services

The successful MHRA inspection was done at Concept’s Dundee site in December 2017, confirming GLP accreditation for in vitro safety studies and bioanalysis. The accreditation increases the breadth of services the company is able to offer to customers requiring regulatory studies, and provides assurance of data integrity and compliance with international standards, ensuring acceptance of the data by global regulatory bodies.

The accreditation forms part of a phased plan over H1 2018 to expand GXP compliance (including GLP and GMP) at the company’s facilities across the UK, to expand services to manufacture of API material, and to further support development of compounds from the discovery stage to full IND packages.

John Handley, Chief Operating Officer, Concept Life Sciences, said: “Concept Life Sciences has a strategy in place to expand GXP compliance across multiple sites, as part of our drive to expand the services we offer to our clients. We are delighted that the Dundee site has achieved GLP certification, and look forward to announcing the next stage in the growth of the company.”

GLP refers to a quality system of management controls to ensure uniformity, consistency, reliability, reproducibility, quality and integrity in non-clinical laboratory studies and gives confidence in the safety assessment of a compound. GLP applies to the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products, and to many other non-pharmaceutical agents such as colour additives, food additives, food contamination limits, food packaging, and medical devices.

Read More

Related news

Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines

Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines

8 Aug 2018

Company moves away from manual processing in favour of automated, scalable platforms.

Read more 
A new era for migraine patients

A new era for migraine patients

6 Aug 2018

EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.

Read more 
WuXi STA and Antengene sign development and manufacturing agreement

WuXi STA and Antengene sign development and manufacturing agreement

24 Jul 2018

WuXi STA chosen for its end-to-end CMC platform for new drug development.

Read more 
ProBioGen and Pionyr initiate 2nd immuno-oncology contract development and manufacturing project

ProBioGen and Pionyr initiate 2nd immuno-oncology contract development and manufacturing project

18 Jul 2018

Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline.

Read more 
New screening company exploits the latest advances in microfluidics and 3D culture

New screening company exploits the latest advances in microfluidics and 3D culture

19 Jul 2018

The ability to micro size drug-cell interactions will allow pharmaceutical and biotech companies to do 100x more testing for the same money spent as well as increasing productivity.

Read more 
Natural lipid acts as potent anti-inflammatory

Natural lipid acts as potent anti-inflammatory

10 Jul 2018

Scientists see therapeutic potential against bacteria, viruses.

Read more 
Plasticell leads gene therapy manufacturing consortium

Plasticell leads gene therapy manufacturing consortium

3 Jul 2018

Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies.

Read more 
Follicum develops new direct-to-scalp formulation

Follicum develops new direct-to-scalp formulation

27 Jun 2018

The topical treatment for hair loss boasts a 'commercial' formulation.

Read more 
Collaboration to provide GMP-based services

Collaboration to provide GMP-based services

19 Jun 2018

Researchers to benefit by receiving a rapid and cost-effective scaled supply of new compounds.

Read more 
Locate Therapeutics secures £2 million to fast-track development of innovative cell therapy programs

Locate Therapeutics secures £2 million to fast-track development of innovative cell therapy programs

5 Jun 2018

TAOS matrix system and products hailed as potential ‘game changers’ in the field of regenerative medicine.

Read more