Business Biotics Group harnesses more than 40 years experience to offer our clients profitable solutions for their pharmaceutical/biotech business imperatives.

Our expertise stretches beyond the boundaries of architectural design and detailed engineering, and incorporates business solutions that are based on sound financial principals, designed to assist the client achieve maximum commercial benefits.

Our competency is founded on a history of successful business implementations in the pharma/biotech space, involving novel strategies for new product manufacturing processes and facilities upgrades.

Our experience stretches across many regulatory environments including the FDA, TGA EMEA, Medsafe and the SFDA

We offer:

• Strategic financial planning advice culminating in viable financial models to suite the most demanding business strategies. This includes the development of Net Present Value analysis, Cost Modelling Scenarios, Business Risk Analysis Assessments and Contingency Planning Models.

• GMP conformance planning advice for executive management on projects involving a new product manufacturing process and facility redesign or upgrade elements. Business Biotics Group understands that all pharmaceutical projects must achieve a workable balance between GMP compliance and profitability.

• New product development validation modelling for the successful transition from an R&D concept through to market commercialisation. We generate strategic validation master planning information to assist the client achieve commercial realization with maximum cost efficiency.

• Facility, plant and equipment upgrades. We start at the top and financially justify the project, strengthening it all the way with tight project management and technical review controls. We customise these specifically for the individual requirements of the client. Our design review entails a phased approach, whereby GMP conformance, manufacturing competency and cost markers are constantly assessed.

• Aseptic and sterile processing consultancy services. Our breadth of expertise is unmatched in the area of aseptic and sterile processing. Our inherent knowledge of aseptic process manufacturing allows us to design your small or large scale aseptic process to ensure a realistic level of GMP compliance and maximum return on investment. Our range of services includes:

• Process design and product flows.
• Implementation of environmental monitoring systems, both active and passive for ensuring that aseptic conditions are maintained in Class 100-100,000 (ISO 5-8) zones.
• Contamination control and management of aseptic processing areas, containment facilities and other rated clean room operations.
• Selection of routine cleaning and sanitation processes, capable of maintaining rated clean room standards.
• Specification of clean room apparel suitable for required production and operator safety in Class 100-100,000 (ISO 5-8) zones.
• Specialised aseptic operator training to ensure compliance to required regulatory and safety standards.
• Problem investigation and solution recommendation.
• Staff compliance audits for conformance with prescribed procedures.
• Independent analysis and recommendation of major production process deviation and non-compliance issues.
• Draft all of your manufacturing documentation in accordance with the required cGMP’s.These include:

• Batch Process Sheets
• Standard Operating Procedures
• Production Forms
• Master Processing Instructions
• Training modules (cGMP and Technical)
• Competency based training modules
• Other GMP production documentation

• Specialised areas of packaging materials technology: Our range of services include:

• Selection of plastics for specialised applications i.e. form-fill-and-seal and container technology
• Selection of flexible and semi flexible foil laminates for bag filling and blister packing
• Selection of suitable rubbers for stopper applications
• Selection secondary packaging components i.e. closures, self adhesive labels, corrugated board and boards for carton conversion
• Testing of primary and secondary packaging components
• Selection of semi automated or fully automated computer aided product inspection systems for standalone or inline product quality assurance