DSM Celebrates Opening of New cGMP Facility for Biopharmac?eutical Manufactur?ing in Brisbane, Australia
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, today officially opens its new cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia.
The facility was built in partnership with Biopharmaceuticals Australia with co-operation from the government of Queensland and the Commonwealth of Australia. This world-class operation in the Asia-Pacific region is an important growth area in DSM’s strategic development in the biopharmaceutical field.
The facility was designed by an expert international team of biological scientists and bioengineers, utilising DSM's 27 years of experience in mammalian cell culture processing to construct a purpose-built, state-of-the-art biomanufacturing facility.
The Brisbane facility offers cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing.
Lukas Utiger, President and CEO, DSM Pharmaceutical Products, stated: “With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing. It represents an important milestone in the development of Australia-based mammalian cell-based manufacturing of biopharmaceuticals, and extends DSM’s contribution to the global biotechnology market.”
DSM Biologics, the business unit of DSM Pharmaceutical Products that operates the Brisbane facility, also offers process development and cGMP manufacturing in Groningen, The Netherlands; together with the Brisbane site now servicing customers in all clinical stages from preclinical through Phase III and commercial manufacturing. DSM previously announced contracts for the Brisbane site with DecImmune Therapeutics of Cambridge, Massachusetts, USA; RECEPTA Biopharma in São Paulo, Brazil; Paranta Biosciences of Melbourne, Australia and, today, with Opthea Pty Ltd of Melbourne, Australia.
The Brisbane facility has an output capability of 500 kg and has expansion space available for further capacity utilisation. In June of this year, the Brisbane site was thoroughly assessed by inspectors from TGA (Therapeutic Goods Act). “On 4 September, the site was granted a rating of ‘A2, satisfactory compliance with the manufacturing standard established under the Therapeutic Goods Act 1989’. With the October opening DSM will conduct process development work, and make technical production runs. With a TGA manufacturing license cGMP commercial production will begin in January 2014,” commented Manja Bouman, President of DSM Biologics.
The Brisbane facility is DSM's blueprint for its 'biologics plant of the future' for the production of biopharmaceuticals. As well as all industry-standard technologies, DSM also has its own innovative proprietary technologies: XD process technology and Rhobust direct capture technology, for the optimisation of therapeutic biopharmaceutical manufacturing, which drive down cost, processing times and capital requirements to meet market demand for developing affordable lifesaving medications.
XD is DSM’s proprietary cell culture technology with product output 5-25 times higher compared with the current standard biomanufacturing processes. It produces very high cell densities while retaining high cell viability and consistent product quality. Rhobust is DSM’s proprietary direct capture downstream technology which combines clarification and product capture into one single step.
XD and Rhobust are registered trademarks of Royal DSM.
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance