Symbiosis secures FDA viral vector process approval

5 Oct 2018

Strengthens the CDMO's position as a centre of excellence as part of the viral vector drug development supply chain.

Symbiosis Pharmaceutical Services has reported FDA approval for its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK.

Symbiosis secures FDA viral vector process approval

Symbiosis recently hosted a successful inspection by the FDA for the aseptic manufacture of viral vector products for commercial supply into the US market at its GMP manufacturing facility, which has been licensed by the UK government's regulators, the MHRA, since 2012.

Colin MacKay, CEO at Symbiosis Pharmaceutical Services, commented: “The approval of this process at Symbiosis by the FDA is testament to our technical experience, capabilities, and specialist understanding of viral vector filling in compliance with the highest of regulatory standards.

“We have been honing our niche viral vector handling and manufacturing skills for several years and have dedicated resource and effort to maintaining the strict quality standards and expertise required to make the commercial GMP sterile filling of viral vectors a core capability at Symbiosis.

“This FDA inspection milestone is directly supportive of our recently reported success in being awarded a £1.9 million (US$ 2.4 million) grant from the UK government's funding body, Innovate UK, which was directed at strengthening the position of Symbiosis as a centre of excellence as part of the viral vector drug development supply chain, and firmly consolidating the commercial viral vector manufacturing capability of the UK as a global leader in this field.

“The FDA approval of Symbiosis, alongside its Innovate UK grant success, represents a significant positive indicator which supports the development of world-leading capabilities for clinical and commercial production of gene and immunotherapy viral vector drug substance and drug product manufacturing in the UK.”

MacKay continued: “Our ability to offer rapid access to sterile manufacturing slots has been a key competitive differentiator compared with the larger CDMOs in the outsourcing marketplace and has succeeded in leading to long-term relationships being built with pre-clinical, Phase I-III, and now commercial-stage biotech and pharma companies worldwide.”

Read More

Related news

New HCP Kit for automated impurity analysis of biotherapeutics

New HCP Kit for automated impurity analysis of biotherapeutics

21 Jun 2019

Ready-to-use immunoassay kit increases analytical output and productivity in bioprocess workflows.

Read more 
Sanofi and Google to develop new healthcare Innovation Lab

Sanofi and Google to develop new healthcare Innovation Lab

20 Jun 2019

Collaboration aims to change how Sanofi develops new treatments and will focus on to better understand patients and diseases, to increase Sanofi’s operational efficiency, and to improve the experience of Sanofi’s patients and customers.

Read more 
Catalent to purchase BMS manufacturing facility

Catalent to purchase BMS manufacturing facility

19 Jun 2019

Customers to have access to state-of-the-art sterile biologics fill/finish and oral solids manufacturing and packaging platforms.

Read more 
Inaugural Bio Integrates conference highlights industry's inefficiency in developing products

Inaugural Bio Integrates conference highlights industry's inefficiency in developing products

18 Jun 2019

Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.

Read more 
Colorcon launches Opadry Enteric for use with hydro-alcoholic media

Colorcon launches Opadry Enteric for use with hydro-alcoholic media

17 Jun 2019

A fully formulated one-step system providing simple preparation and ease-of-use for film coating.

Read more 
SenzaGen granted its first patent for GARD potency biomarker test

SenzaGen granted its first patent for GARD potency biomarker test

16 Jun 2019

Company can now offer an animal-free test method to quantify the strength of an allergenic effect.

Read more 
Affordable measles and rubella vaccines using NevoLine manufacturing platform

Affordable measles and rubella vaccines using NevoLine manufacturing platform

14 Jun 2019

Univercells' propriety bioproduction platform has already proven success.

Read more 
Leaf Expression Systems launches first line of Hypertrans research products

Leaf Expression Systems launches first line of Hypertrans research products

13 Jun 2019

Plant-expression deal for difficult to produce proteins, vaccines, metabolites and natural proteins.

Read more 
Clinical supply milestone reached for triple-negative breast cancer treatment

Clinical supply milestone reached for triple-negative breast cancer treatment

12 Jun 2019

PhoenixMD and WuXi STA have produced a multikilogram drug supply for PMD-026 under GMP manufacturing practices.

Read more 
Combining IT and OT software to solve manufacturing’s most frequent challenges

Combining IT and OT software to solve manufacturing’s most frequent challenges

11 Jun 2019

PTC and Rockwell Automation combine technologies to accelerate customers’ digital transformation initiatives.

Read more