Leveraging our significant industry experience and world-wide network, the CBE partners and their affiliates have successfully completed a range of projects. These completed projects have complemented and extended our current offerings in the region and have provided significant value for our clients. A selection of case studies have been prepared below. Please click on each project for more information.

GMP AND QUALITY COMPLIANCE

1. Quality Management Systems: Bioprocessing company wanting a review of the QMS, training and GMP standards

Situation: Bioprocessing company wanted an evaluation of the Quality Management System and targeted training for key staff in pharmaceutical GMP as it related to their process.

Process: Conducted a review of the production process against the current documentation and identified gaps. Provided a group training session to highlight where the Company’s products fit within the pharmaceutical industry. Conducted one-on-one training for key Production and QC staff using a HACCP (Hazard Analysis and Critical Control Points) format and risk assessment as it relates to the production process steps.

Outcome:

  • Documented training records were generated that outlined the training delivered.
  • Staff maintained their own training records as they worked through the HACCP analysis.
  • Production and Quality staff gained a better understanding of GMP and gaps in the QMS and were empowered to make the relevant documentation and process changes.
  • The project resulted in enhanced preparedness for regulatory and pharmaceutical customer audits.

2. Biotechnology/Vaccine Network Training in Quality Systems and GMPs

Situation: An International Vaccine network supported by the Bill Gates Foundation, requires the development and delivery of WHO/PICs/FDA quality systems and GMPs across their network in Asia. The purpose of the training is to improve quality standards of vaccine manufacturers in developing countries.

Process: CBE developed specific multiple training programs based on case work and workshops in the areas of Quality Systems, Validation, Aseptic Processing, Cleaning, Environmental Monitoring and Sterilisation. As part of the program CBE consultants were also invited to provide a one day GMP gap assessment of vaccine manufacturers in China and Vietnam.

Outcome:

  • Quality Systems and GMP training have been provided to the Vaccine Network members in China, Vietnam and India.
  • Each workshop was attended by over 60 members representing approximately 40 companies.
  • Assessments indicated that knowledge levels had improved by over 25% as a result training.

3. Asian Biotechnology Firm receives a critical audit from PICs/TGA

Situation: An international biotechnology company’s strategic plan was to rapidly expand their product portfolio into international markets. They underwent a GMP licensing audit from TGA which identified some significant gaps to PICs/EMA/FDA standards. The firm engaged CBE to assist them in identifying and closing the gaps, and to prepare for re-inspection.

Process: A team of CBE experts in Quality Systems, Quality Control, GMP, Validation, Manufacturing and Pharmaceutical Engineering visited the site on 3 occasions over a four month period and conducted a full gap analysis to international standards. Working closely with senior management the team (a) prepared a systematic and detailed corrective action plan for TGA (Phase 1) and (b) provided a comprehensive improvement plan for implementation over the following 12 months (Phase 2). In addition CBE identified that the site needed to plan and implement a GMP audit preparedness program to successfully manage future audit outcomes.

Outcome:

  • The company has submitted the CAPA plan to the regulator and is anticipating successful re-inspection in 2016.
  • The company has also strengthened their quality system in areas such as deviation management, internal auditing, problem investigation, quality metrics and CAPA oversight.
  • Senior staff now have a management plan to improve regulatory inspection outcomes.

4. Industry Training in current best practice in GMPs and Quality Management

Situation: A regional Pharmaceutical Manufacturers Association provides ongoing professional development training for its membership. The association requested CBE to develop rolling three day workshops and presentations to industry professionals. The course had to be practical, hands on and filled with industry case studies.

Process: A regional Pharmaceutical Manufacturers Association provides ongoing professional development training for its membership. The association requested CBE to develop rolling three day workshops and presentations to industry professionals. The course had to be practical, hands on and filled with industry case studies.

Outcome:

  • The courses are regularly attended by industry professionals including authorised persons, laboratory managers, production managers and validation managers.
  • Courses always rate highly and attendees often exceed 80 personnel.
  • The program has been running successfully for nearly five years under this format.

5. An Asian start up company developing a Biological for critical care required “tailor made” training programs for all staff

Situation: An Asian start up company with a young enthusiastic team required training program to ensure that staff were familiar and up to date with current EU/FDA/TGA quality standards particularly in the area of aseptic processing. Additionally management wanted their team to be well informed on viral inactivation / removal processes and the regulatory requirements with respect to process validation for viral clearance steps. Finally, as tangential flow flitration technology is extensively used in their processes they required a course on process optimisation of this technology.

Process: A comprehensive program was developed and delivered over 2 days covering Sterilization Theory and GMP requirements (particularly steam sterilization); Aseptic processing and media fill validation and Sterile filter validation and control, Testing (QC) Programs for biological products; Viral Inactivation technologies and validation; Tangential Flow Filtration Technologies and process optimization.

Outcome:

  • The course was delivered over 2 days to approximately 40 participants with a half day of open and follow up questions.
  • Participants then completed an exam designed to reinforce teachings and ensure participants had understood and learned content.
  • Participants were able to pass the exam at the end of the course and were issued with a certificate of completion.
  • The team are now well positioned to develop EU/FDA/TGA compliant and optimized manufacturing processes for the Biological in development.

FACILITIES AND PROCESS DESIGN

6. Risk based process review: A chemotherapy compounding company has facility rejected by a state authority and requests assistance

Situation: Chemotherapy compounding facility has their newly built facility rejected by the state authority due to concerns about the facility design, equipment and production processes.

Process: The process involved providing engineering and quality expertise to lead a risk assessment process across the facility, equipment and production. The risk assessment identified a range of deficiencies. These risks were mitigated through a series of facility modifications, qualification work on the equipment and some internal changes to the aseptic practices.

Outcome:

  • The risk assessment report, qualification report and details on proposed changes to the layout and HVAC system were compiled and presented to the state authority.
  • The state authority accepted the evidence provided and allowed the facility to be upgraded and commence production.

7. Facility Upgrade: Hospital requests assistance on upgrading compounding pharmacy

Situation: A hospital had recently built a new compounding pharmacy and had concerns about the quality of the finishes and whether the design met the current and proposed Australian standards.

Process: A site visit by a CBE engineer assessed the facility and found a range of problems from poor finish details through to inappropriately located supply HEPA filters. A comprehensive report was prepared that outlined the issues found, provided references where they did not meet the required standards and categorized the issues into high, medium and low criticality.

Outcome:

  • The hospital was able to review the report and efficiently implement a rectification plan.
  • The works were quickly completed and a pre-commissioning inspection by the CBE engineer found that the rectification work was completed to a high standard.
  • Some minor detailing work was corrected, and the facility was commissioned, certified and commenced production.

8. Technical Support for Substantial Upgrade of Existing Facility on Asia

Situation: A Hong Kong based manufacturer has invested in a substantial upgrade of their non-sterile manufacturing facility to meet current and future PICs requirements. The client had not undertaken a project of this nature before and looked to CBE to provide technical expertise and support across Quality Management, Validation, Training and eQMS implementation.

Process: CBE conducted a gap analysis and formed a small project team with cross–functional skills to support the site in execution of the plan. This involved a complete re-structure of the QMS, transition to an affordable eQMS, development of a validation master plan based on risk analysis, and preparation of PQ, PV and cleaning validation protocols. The project also involved mentoring site management and supporting them in facilitating a regulatory audit.

Outcome:

  • The site is well progressed and on track to host a regulatory licensing inspection in May 2016.
  • The QMS is embedded and the validation program has progressed to the PQ/PV stage.
  • The site expects to be in full operation by mid 2016.

RESEARCH AND DEVELOPMENT

9. Biopharma investment in China: Private equity company wanting a risk assessment on a potential investment in China

Situation: Private Equity company considering investing in a biopharmaceutical business in China wanted more information on risks, product portolio and strength of R&D program.

Process: The process involved leading the equity team in a series of meetings addressing and testing assumptions presented by the company to the team. The process included several site visits and was supported by an interpreter provided by a CBE affiliate company based in China.

Outcome:

A comprehensive report was prepared summarizing

  • Key risks and the Chinese company’s risk mitigation strategies.
  • Strength of the product portfolio against competitors in China and potential international competition.
  • GMP standards applied at manufacturing sites.
  • The strength of R&D new product portfolio, product development strategies and fit with emerging market opportunities.
  • Process improvement initiatives, alignment with modeled forecast yield improvements and a comparison with international best practices.

10. Government Funding Application: A large Biopharmaceutical company planning expansions in R&D and manufacturing facilities seeks government funding

Situation: An international company having options to invest in multiple countries was seeking government funding as an incentive to invest.

Process: With a qualified economist a detailed paper was prepared outlining the magnitude of investment, the flow on benefits and technology platform that the investment would create. The paper demonstrated significant return on investment to government in future years. The paper was presented to multiple government departments.

Outcome:

  • Significant funding was achieved conditional upon meeting defined milestones.
  • Milestones were met and facilities are now in operation.

11. Manufacturing scale up and minimising time to market

Situation: A Startup biotechnology company acquired intellectual property and required a comprehensive manufacturing strategy to minimise time to market. The strategy included ensuring product specifications and process controls were in place to demonstrate the scaled up manufacturing process resulted in product equivalent to product used in clinical trials.

Process: Gathered a team with the relevant skills and reviewed the pilot scale process to determine requirements for scaled up manufacture. Put in place protocols and additional testing required to demonstrate product equivalence with clinical trial material. Identified a suitable manufacturing partner with the relevant regulatory approvals and entered into in-principle discussions.

Outcome:

  • A timeline, with indicative costs was developed and a strategy prepared to allow planning and risk management.

OPERATIONS MANAGEMENT

12. Reduction in Compliance Costs: Pharmaceutical Contract Manufacturing Organisation wanting a review of quality operations

Situation: Pharmaceutical CMO experienced downturn in annual revenue and was looking for opportunities to increase competitiveness across operations, including quality and technical functions, without compromising quality standards. Target of $3M pa savings.

Process: Conducted a review of current operations using DMAIC (Define, Measure, Analyse, Improve and Control) process. Led a cross functional team through an exercise to re-define key quality indicators and performance measures for quality and technical functions to enable further improvements to efficiency and effectiveness.

Outcome:

Led a cross functional team through a successful change process resulting in:

  • Enhanced understanding of KPIs and performance for quality and technical functions.
  • Cost savings of $750k in cycle 1, (4 months).
  • Further savings identified and projects implemented to reach target of $3M over 2 subsequent cycles in 18 months.
  • Company quality/technical staff gained increased awareness of quality costs and were empowered to manage these.
  • Enhanced appreciation of cross-functional responsibilities in management of quality costs.

13. SAP Implementation: Biopharmaceutical company requests assistance in integrating Australian facility with the company’s international manufacturing network

Situation: A leading, global Biopharmaceutical company has an ambitious project timeline to implement a new SAP ERP system in line with its international practices which involves switching from another ERP environment. Business activities include data readiness and pre / post load data verification, review of procedures & training material, defect resolution and readying the Business to successfully move to the new ERP system – on schedule with minimal interruption to manufacturing schedules.

Process: The process involved CBE providing an experienced Manufacturing Executive to lead the business team delegates from all key areas including Finance, Sales & Distribution and Manufacturing Operations for a period of 8 months. This period included the critical phases of deployment and post go-live “hypercare”. The process required constant interaction with the Project Leadership Team, Business Streams, Data Migration Team and Senior Site Management Team. This SAP implementation was one of the most complex implementations attempted by this Biopharmaceutical manufacturer.

Outcome:

  • The Project Timeline and associated activities, including the critical SAP Go-Live milestone, were met on time with excellent results and minimal interruption to the business activities
  • The Project outcome has reset the benchmark within this very successful global business

14. Supply Chain Efficiency: A blood collection agency wants to find the best solution for collecting, testing & supplying blood products to customers

Situation: A Government Human Blood Collection and Processing Business has misalignment between its donor collection schedules and customer order dispatch schedules. The Production Services Manager asks the Testing Manager to extend the Laboratory Testing hours to include nightshift hours in order to solve the problem. Is this the best way?

Process: The process involved bringing together representatives from the Testing, Distribution, Processing and Collection Teams to analyse if there was a suitable alternative to adding an expensive nightshift, yet ensuring the right quantities of fresh components were available to replenish the metropolitan hospitals inventory in the early evening. Together the existing process was mapped and potential solutions discussed.

Outcome:

  • By working together and mapping the process from blood collection to distribution, the Team was able to come up with a very simple method of deprioritizing those test samples associated with collections which would be frozen and have a longer shelf life.
  • This allowed the testing of the shorter shelf life platelet products to be prioritized and released to distribution in time for the evening deliveries to hospitals.
  • This was an inexpensive solution which required some retraining of staff, changes to procedures and importantly – no additional, expensive Testing nightshift!