OUR SERVICES

WHAT WE DO

The aseptic fill and finish of a product is a process common to liquid based medicinal products and medical devices. The process requires expensive equipment that requires significant expertise to run efficiently, in a compliant manner.

For emerging companies, the translation process can be difficult to navigate. The options for local, accredited/licenced, and cost-effective solutions are limited.

At CBE Pure Solutions we not only provide the fill and finish services, we support it with comprehensive monitoring and testing services, particularly in the area of environmental monitoring and sterility testing services.

WE OFFER

  • An experienced team focussed on the customer experience through delivery of innovative, compliant, and cost and time effective solutions.

  • Sterile and low bioburden fill and finish solutions – the final stage of manufacturing where the product goes into its final presentation and packaging.

  • A focus on early stage and small-scale commercial products, with equipment that can provide a number of volumes, presentations such as vials and syringes and options such as gas or vacuum filled units.

  • We cater to a wide range of products such as placebos, diagnostics, vaccines, and therapies across platforms such as biologics, pharmaceuticals, APIs, medical foods, animal health and emerging technologies.

  • Expert microbiologists, providing a range of testing and monitoring services to support our own products and the wider industry.

  • Flexible and efficient services, providing quick turnaround for our customers.

  • Advice and support services relating to materials sourcing, procurement, validation, analytical testing, microbiological testing, and stability programs.

  • Links to CBE consultants for technical consulting services to support facility design, project management, quality management, customised training solutions, strategic planning, and commercialisation.

Contract Manufacture

  • Offering contract manufacture fill and finish services for low bioburden liquid products for high volume, small container solutions.

Clinical Trial Manufacture

  • Offering manufacturing services including basic formulation and fill and finish services for sterile products, particularly for small runs such as products for clinical trials.

Microbiological Testing

  • Microbiological testing services, including sterility testing, microbial limit testing, endotoxin testing and environmental monitoring for both raw materials and finished products.

Training

  • We offer hands-on aseptic training in a simulated GMP environment to our clients and the wider healthcare community. We are a Consortia member for CBE's GMP Uplift training programs supported by MTPConnnect's REDI Initiative, providing GMP Hands-on Training as part of the GMP skills development program.

OUR CUSTOMERS

  • We serve CDMOs, Universities, Research Institutes, Startups, Small to Medium enterprises, as well as larger Medical, Technology and Pharmaceutical (MTP), Biotechnology, Medical Food and Animal Health firms.

  • We service customers with clinical trial materials, first prototype runs and early-stage production and facilitate translation of high-quality medical research; taking assets in development and early phase commercial, through to launch of commercial products.

  • This service will directly aid companies to develop and translate in Australia, by allowing companies to undertake first production runs, prototyping and scale-up manufacturing here supporting our growing clinical trials industry and biotech within the AsiaPacific region. 

OUR DIFFERENCE

  • Product manufacture requires a team – we partner with our clients to deliver high quality, reliable and affordable GMP manufacturing and testing solutions.

  • Sterile technology is changing and regulatory demands are increasing – CBEPS are experts in this complex environment.

  • We work with numerous early phase clinical clients and start-ups – we understand their challenges.

  • Our team has extensive Australian and international experience in GMP manufacture, quality and compliance – our track record provides our clients confidence in compliance.

WE PROVIDE

Manufacturing and testing in state of the art facilities, with advanced equipment and innovative processes
Helping our customers through ensuring product quality and compliance

Expertise in development, tech transfer and scale up to realise new assets
By partnering with our customers, we look to simplify the process and look for efficiencies, ensuring speed to market

Solutions to meet our customer’s needs and make the finishing of the product simple
Giving our customers focused services and solutions, without complexity

Expertise in sterile solutions, manufacture and testing, using best in class technologies and processes
Providing our customers with reliable services and confidence in quality and costs