Adherence to the fundamentals of vaccine production in South America

• Understanding and anticipating the complexity generating influenza vaccines
• Successfully managing through the global environment – cultural, language differences, communications
• Ensuring success for everyone on both sides of the transfer

Implementing opex principals to radically improve manufacturing output whilst maintaining quality

• Investing in cultural enablement to empower the shop floor to guarantee true change and accountability
• How can you sustain change in your operational excellence programme?
• Fully demonstrating productivity improvements and bottom line benefits to the wider organisation

Implementing a successful manufacturing execution system in genzyme's geel plant

• Successfully meeting objectives for implementing MES
• Understanding the project setup and execution
• Efficiently moving to a paperless based environment
• Understanding the current preparations for the go-live programme  (4^th Quarter 2012)

Creating a defect free process to eliminate risk in biomanufacturing

• Applying up to date lean concepts in biotech operations by setting clear operational standards and reducing human error mistakes
• Focusing on interaction between human and equipment process
• Creating an advanced and reliable way to find a root cause of recurrent biotechnology issues
• Eradication of defects and mistakes in daily operations
• Increasing process robustness by incorporating all the major operational standards and mistake proof mechanisms
• Achieving targets by creating a culture of defining, monitoring and improving operational standards
• Overcoming operational challenges by working together in manufacturing and compliance to achieve operational results

Do we still need the P in GMP? - Biotech facility design from today to tomorrow

• How different are biotech facilities?
• Human impact on facility design
• Limitations of a risk based approach
• Role of time and investment on the future of facility design
• Standardisation as door opener to a new design approach

The role of automated rapid detection in sterility and environmental monitoring

• The challenges of current methods
• Limiting factors to rapid micro method adoption
• Key areas of value from automated rapid detection

Recent innovations to improve process economics of antibody production

• New protein particle based chromatographic media
• Advanced composite housings for purification of biologics
• CIMmultusTM - disposable Monolithic columns to improve process economics of antibodies and other biomolecules polishing steps

From innovative calibration concepts to operational excellence

• Integrated calibration concepts for robust and efficient processes 
• How to integrate calibration into operations and increase plant efficiency
• Online information availability
• How to improve business processes
• eCalibration

Enhancing process stability and limiting variability to optimise process development

• Using PAT to fully analyse a biomanufacturing process
• Successfully using PAT to achieve real time data
• Creating sustainable, reproducible and transferable biomanufacturing systems
• Reducing the cost of your bioproduction operations

Using winning strategies to mitigate human error in production

• Collating and analysing data to understand the root causes and drivers of human error
• Deploying solutions to overcome human error in manufacturing
• Supporting human reliability
• Utilising root cause management systems to prevent and reduce deviations

Development of the ACF CHO suspension production platform CHO^BC

• Antibody production using CHO^BC
• The PER.C6® platform as human alternative
• The Potelligent® platform for enhanced effecter functions of cancer antibodies
• CELL-tainer® disposable bioreactor for up-scaling and comparison to STR

Impact of closed system processing on facility design and operation for concurrent manufacture of multiple biopharmaceutical bulk drug substances

Sharing case studies, showing reliable process improvement regarding:

• Risk avoidance
• Deviation reduction
• Communication in shift models

Creating a fully flexible and disposable manufacturing strategy for mass production

• Designing and implementing a single use facility
• Setting up a new platform from design to implementation
• Designing the single use process before designing the building for it
• Creating an efficient disposable manufacturing process to increase productivity
• Overcoming the barriers of technology for single use platforms
• Reducing cost of goods

Purification of a common light chain bispecific antibody using Contichrom (MCSGP)

• A human  bispecific common light chain IgG antibody (AB) was purified from PER.C6 cell culture harvest with high yield and high purity using a three-step chromatographic downstream process.
• The key to successful purification of AB was the operation of the first polishing step with Contichrom in MCSGP mode that enabled a step yield of 87% and a purity of > 99% AB.
• The presented data shows that Contichrom in MCSGP mode enables the economic production of bispecific antibodies thereby removing the bottleneck in downstream processing for this product class.

A case study: using QBD for A-Mab in knowledge management

• Understanding how to implement QBD and the current status of projects
• Efficiently using technical tools and software to gain knowledge management from data and identifying gaps
• Conducting a quality risk assessment by gaining knowledge in unit operations
• Fully understanding every individual step from early discovery through to manufacturing
• Supporting knowledge management in pharma by using data management

• Creating a highly productive CHO process in development
• Shorten timelines from DNA to IND in process development
• High-throughput pool and clone screening
• Using DoE-based approaches to enable high titre processes
• Implementation of disposable technologies in process development
• Reduce costs in development and CoG in production

Combining upstream/downstream data and connecting all process steps together

• Creating a process control scheme that is adaptive to inherent process variability, but is a mathematically closed system
• Understanding concepts of closed systems and expectations
• Using the optimal disposable USP devices
• Turning open DSP process to a closed one
• Understanding the regulatory constraints of a closed process
• Exploring the full potential for fully closed systems in a multiproduct environment
• Using closed systems to optimise both up and downstream processes by connecting crucial steps together

Lean Six Sigma : Fashion or Fundamental?

• How realising benefits from Lean Six Sigma inspired conversion from sceptics to champions in a biologics Road to Damascus
• Hear examples from Fujifilm Diosynth Biotechnologies’ CMO operations in Europe and the USA to show how Lean Six Sigma methods have been used to deliver benefits and create more value for customers by reducing time from gene to vial
• Increasing efficiency and lower cost-of-goods
• Improving communication
• Reducing stress!

• New strategies for integrated virus and contaminant clearance that are sustainable and economically attractive
• Understand the impact of modern ligand chemistries, membrane surface modification and prefiltration on modern polishing operations
• Orthogonal Concept 
• Case studies discussed

Improving process efficiency in biomanufacturing

• Chromatographic solutions for downstream processing, process analytics and quality control of biologics that help to increase throughput and cut down production costs
• Reduced process cycle times and costs in large and small scale mAb purification – two case studies
• Save water for injection (WFI) with TOYOPEARL gigacap ion exchange resins
• New approaches to antibody analysis – charge variants, glycosylation, aggregates & fragments

Efficient workflow for purification of a monoclonal IgM

• A monoclonal IgM antibody that is unstable at pH
• A novel salt tolerant chromatography media was used to capture this IgM mAb at near neutral pH without dilution after a partial purification step to remove DNA; final polish was carried out on CHT media
• Describe a simple process that yields highly purified, biologically active IgM free of aggregates

Constant chromatography innovation to increase productivity during the processing of biopharmaceuticals

• Optimisation of plant utilisation using a high salt tolerant multi mode media
• Improvement of process productivity with membrane absorbers
• Influence of resin characteristics on monomer / aggregate separation efficiency by looking on a variety of CEX resins

• Sustainably improving control of process variability
• Working with process data
• Minimising barriers to effective collaboration between Process Development, Manufacturing and Quality Assurance teams

Importance of the end of run studies and real time monitoring for the evaluation of a microcarrier based cell culture perfusion process

• Successfully demonstrating robustness of manufacturing processes by linking the relationship between key operating parameters and final performance
• Maximising protein yield whilst ensuring efficacy of the molecules
• Overcoming the challenges of scale up of commercial cell culture by homogeneous mixing of the bioreactor to increase biomass and cell productivity
• Successfully using 4000L bioreactor to aid scale up issues and overcoming engineering parameters.
• Using FDA’s analytical technology initiative by using novel technologies to obtain more information on the substrate

Successfully establishing an error proof system in internal and external tech transfer

• Understanding regulatory challenges, establishing the right action at the right time
• Successfully applying risk based control strategies for tech tech transfer
• Overcoming GMP issues and documentation

Fully understanding the link between process development and manufacturing using platform knowledge

• Using a scalable approach to convert data to information
• Beyond the definition of a statistically regressed design space: Extraction of platform knowledge by information processing
• Using effective tools to differentiate product and clone specific process parameters
• Understanding the dynamic process conditions to analyse more than effects of inhomogeneities in bioreactors

Optimising DSP by using the next generation tools, technologies and techniques

• Successfully using lean and six sigma for large scale biomanufacturing production
• Using full closed systems to connect up and down stream processes together
• Efficiently reducing bottlenecks by improving the interphase between USP and DSP processes
• Using the latest continuous chromatography technologies

Identify quality attributes that are truly critical to safety and efficacy, and their acceptable boundaries

• Moving away from empirical approaches to process design which are fundamentally contradictory to QbD
• Developing robust processes earlier in the development timeline and ensuring processes stay robust later in the development trajectory
• How are companies achieving and measuring value through QbD?
• Becoming leaner, faster, and more cost-effective
• Building quality earlier in the process

Lean development aspects for pilot facilities

• Optimizing pilot plant facilities utilisation
• Insourcing/outsourcing/launching strategies
• Use of disposables in pilot plants: pro’s and con’s

Is business continuity management a site issue or a supply chain issue?

• Building the plan through risk assessment
• Focusing on mitigating large risks
• Utilise inventory to bridge risks
• Preparing the plan from a product perspective

Successfully submitting QbD dossiers and drug master files to the regulatory authorities

Protein PCR: A fully-automated ELISA alternative for residual protein quantification leveraging the advantages of qPCR

• Automation: provides high throughput process with reproducibility and precision
• Recovery: >70% even at high concentrations of IgG; Accuracy: %CV for samples less than 20% (triplicates)
• Sensitivity: ProteinSEQ is about 10-fold more sensitive than traditional ELISA for HCP detection
• Dynamic range: ProteinSEQ has 4 logs compared to ELISA 1 log

Development of a novel chemically defined growth media for CHO cell applications - coupling raw material quality and a design of experiments approach to optimise cell culture media performance

• Successfully developing new-chemically-defined, animal origin-free growth media that is more effective compared to other medias
• Using cell media that has demonstrated impressive purity and consistency for optimised bio-process control for the biosimilar production market

 Using TurboCell technology for stable cell line development-from gene to clone in seven weeks

• Implementing a generic TurboProcess platform ready to scale-up
• Flexible manufacturing in a fully disposable 1000L GMP facility

Efficiently preparing for pandemic situations and manufacturing emergency vaccines

• Implementing manufacturing processes for FluBlok/PanBlok a recombinant protein based influenza vaccine
• Successfully using a combination of single and multi-use equipment to manufacture influenza vaccines rapidly
• Effectively deploying hybrid approaches by using disposable factories and warm base manufacturing facilities

Successful response to the growing biological pipeline by expansion of Roche's Technical R&D infrastructure at Roche Pharma Europe

• Using single-use technologies for process development and clinical supply
• Creating a new electronic data monitoring and archiving tool
• Efficiently refurbishing 5 buildings and constructing new innovative solutions for lab space
• Using latest scale-down robotic tools and a multidimensional platform concept for seamless development from preclinical to launch

Remediation challenges towards raw materials in mammalian cell culture manufacturing

• Avoiding virus contaminations in mammalian cell culture by evaluating raw materials
• Efficiently analysing remediation approaches to address manufacturing facility contamination related to raw materials
• Successfully identifying remediation plans to reduce manufacturing downtime and reducing risk to patient supply

Using continuous techniques vs. traditional batch modes SMB and MCSGP

• Comparison of batch elution and continuous simulated moving bed chromatography
• Setting realistic expectations for chromatography optimisation
• Successfully using high performance counter current chromatography technologies

 ASME-Bioprocessing Equipment (BPE) Standard "a global standard for the BioPharm Industry”

• Scope of the 2009 Standard – “This Standard deals with the requirements of the Bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the subjects of materials, designs, fabrication, pressure systems (vessels and piping), examinations, inspections, testing, and certifications.”
• How a consensus standard can reduce the cost of new facility construction and increase process efficiencies
• Overview of the standard and associated parts
• Preview of the 2012 standard

Efficiently using low cost E.coli  to generate a high yield of therapeutic proteins

• Using the success of fragment antibodies in preclinical and clinical trials to optimise E. coli for production of antibody fragments in manufacturing
• Increasing production of antibody fragments in E. coli by various strategies, such as vector design, strain engineering, co-expressing host cell proteins and process advancement
• Using technological improvements to improve protein yield up to 10 fold, to 2-5g/l.
• Utilising new genetically modified strains in combination with other optimisations to create novel therapeutic formats and supply of research reagents

Successfully transitioning from resin membrane to  continued process verification

• Demonstrating resin/membrane lifetime at scale by monitoring key lifetime indicators to ensure consistent performance and cleanability throughout the lifetime of resin/membranes
• Transitioning from resin/membrane lifetime validation into continued process verification to assure that the resin/membrane lifetime remains in a validated state of control

Establishing critical quality attributes

• Efficiently using QBD for an FC fusion protein
• Listing the known and potential quality attributes of the molecule
• Successfully using a risk assessment methodology to establish criticality
• Using current literature to understand the impact of  quality, safety and efficacy issues
• Assessing the final conclusion of ranking quality attributes

Leveraging upstream process improvements for faster flexible facilities

• Truly continuous – upstream and downstream integration with single use technologies
• Comparison  of concentrated fed-batch versus perfusion options, where is the gain?
• Reducing risk in manufacturing tech transfer

Understanding the advantages of QyuSpeed D membrane: fast and high binding of impurities by convection mechanism, salt tolerance, reusability

• Listening to a client case study: lower volume of chromatography medium, buffer volume reduction, easy setup like for a filter
• Comparing the total cost (materials and process) between traditional Q resin, single use Q membrane and new QyuSpeed D

Application studies for single-use technology

• HyCell CHO – High yield chemically defined medium for CHO cell culture
• S.U.B. TK – Out of the box single-use bioreactor—convenience and performance in one complete package  
• Case Study – CHO cell culture process employing HyCell CHO in the S.U.B. TK

How have advances in technology and procedures made change possible?

• Successfully using alternative cleanroom procedures in biomanufacturing
• Using a risk based approach to optimising control of the environment in operations
• Understanding the concept of functionally closed processes and how to prove we have them
• Creating a future state facility design, evaluating steady state operations and using the associated benefits
• Responding to both internal quality and external regulator's feedback

Efficiently capturing and cementing strategic goals to improve operations and reduce costs    

• Translating a long term business plan to every day actions
• Using visual management as a driver for cultural change
• Reducing cost by flow focus
• Shift in leadership behaviours to support  sustainable change