Setting up an effective formal technology transfer system

• Implementing strict time delivery processes
• Thinking about tech transfer right from R&D
• Enforcing transparent communication projects
• Eliminating cultural and communication differences

 Implementation of lean principles in analytical laboratories

• Establishment of an effective organisational set-up by using lean and six sigma
• Identification of the right associates from pilot plants to manufacturing
• Training and change management executed from the shop floor
• Successfully implementing the 5S, visual management and analytical KPIs
• Sustaining the achievements and implementing continuous improvement in Sandoz

Using a framework to analyse and document technical and business risks associated with inter-site transfer of drug products

Efforts to build process knowledge and control to enable change control and continuous improvement

• Systematic mistake proofing to reduce human error
• Building management practices to drive process control and execution
• Establishing systems to drive sustainable culture change

• Understanding current downstream bottlenecks and how the industry is seeking to address them
• How new and established chromatography resins can be used to achieve simpler, more selective processes
• Case studies: Operational implications from a chromatographer's perspective

• Using sterilisation cleanroom procedures in biomanufacturing environment
• Implementing a risk based procedure to control environmental operations
• Creating a future state facility design that is completely sterile for biologics

• Using advanced chromatography media to seperate antibodies and purify biologics antibodies and other biomolecules polishing steps

• Using Planova BioEX for media nanofiltration
• Why Planova BioEX nanofiltration is a very cost effective solution in preventing bioreactor contamination by viruses
• The benefits of using QyuSpeed D AEX for purification process: easy to use as a filter, excellent impurity removal at high conductivities and possibility to reuse

   

Efficiently linking development data to manufacturing data by creating a faster, more simplified processes

• Creating a robust data process knowledge management strategy right from the onset
• Ensuring that a solid frame work is created to share process information with all stakeholders
• Using early development data through to manufacturing to gain crucial knowledge for manufacturing
• Efficiently creating a platform to share and analyse process information between different teams and organisations 
• Ensuring that the correct tools are in place to gain knowledge from data

Developing and maintaining production processes

• Understanding how to develop and maintain production processes
• Determining the strategy to keep USP processes under control

• Analysing the true benefits of using disposable chromatography such as economics, flexibility and chromatography performance

• Successfully using disposable chromatography in conjunction with continuous chromatography to achieve better purification results

• Understanding how to reduce costs and maximise resources for DSP using disposable chromatography

Successfully meeting EMEA’s expectations

• Leaning from the mistakes of other biopharmaceutical companies who have failed to get approvals from the regulators
• Understanding what regulators require from a QbD dossier and a drug master file
• Achieving regulatory approvals quickly by fully understand QbD principles such as ICH guidelines
• Setting clear CQA and CPP parameters to ensure approval in a QbD dossier

Understanding how to develop and quickly gain approvals for cell culture influenza vaccines

• Using the latest aseptic technologies and meeting safety requirements for flu vaccine manufacturing

• Successfully using a fully closed manufacturing systems to enable propagation of biosafety level III wild type virus and fast response in case of emerging pandemic

• Efficiently gaining licenses for seasonal vaccines in Europe and US meeting regulatory requirements of both markets

Doubling purification productivity by using SMCC

• Developing an effective and continuous DSP
• Using the latest multi stream technologies to reduce buffer consumption for each gram of target protein
• Understanding how streamline DSP

Achieving absolute process control when designing a new biomanufacturing area

• Using data analytics from development to achieve process control to create a design space
• Setting up critical process parameters (CPPs) and critical quality attributes (CQAs)
• Avioding product deviations and demonstrating process control   

Determine the most critical raw materials analysing the level of risk of potential contaminations 

• Understanding how to determine the most critical raw materials in the process and the level of risk of potential contamination
• Identify and overcome contaminations coming from raw materials and the regulatory impact

 Streamlining DSP by integrating USP and DSPs by using the latest lean and six sigma strategies

• Reducing unnecessary steps by creating parallel steps to save time
• Obtaining a 85% product yield in DSP
• Using the latest single-step purification and polishing steps for bioproduction
• Reducing the amount of buffers and resins needed for downstream processes

B.Braun’s LIFE Nutrition plant in Germany is one of the world's most modern production sites built after five years of planning. 

• Gain an insight into the special challenges that were faced in the planning of LIFE Nutrition, including the requirement that the new plant be housed in a building that is spatially identical to their older LIFE plant
• Hear how Bürkert worked with B. Braun to meet their requirements and to achieve maximum capacity with minimum space
• Making cleaning and sterilisation much easier and faster, and enabling quicker changeover for the manufacture of different product types
• Hear how Bürkert was awarded the contract to deliver its patented, space-saving ROBOLUX range of multi-port process valves, and all process fittings, at the €164m life sciences plant

• Building a biomanufacturing facility for tomorrow
• Using the latest technologies for the next generation facility 

• Realising the benefits of implementing a single use Mab production facility
• Practical experiences of implementing single use unit operations
• Short and long term cost savings
• Realising production flexibility

Overcoming the challenges in implementing QbD 

• Defining Critical Quality Attributes (CQA) and collating sufficient data to facilitate process approval

• Characterising your process and establishing best Critical Process Parameters (CPP)

• Generating Analytical Target Profiles (ATP) and deploying the approved QbD process to applicable areas of production

• Establishing key priorities of control and generating a support team and strategy

   

Successfully bringing biosimilars to market vis-a-vis healthcare reforms and rising costs

• Understanding regulatory and industry interaction – building a better regulatory setting for the biosimilar industry of tomorrow
• Efficiently ensuring safety and not over burdening biosimilar products
• Overcoming the technical, clinical, and manufacturing challenges of biosimilars
• Understanding the implications of the healthcare reform on biosimilars

Selecting alternative solutions to purify proteins by using continuous DSP rather than using protein A

• Downstream production can be very expensive, it is vital to use new techniques to produce protein cheaper
• Selecting the optimum resins and buffer solutions to obtain high concentrations of proteins

From B2436 to commercial Jetrea®: a story of how a CMO and Biotech navigated through process development, validation, submission and inspection to approval

• Jetrea®, a new biologic ophthalmic medicine from ThromboGenics NV, received regulatory approval in 2012 from FDA and in 2013 from EMEA
• From early in Jetrea's clinical life ThromboGenics worked with Fujifilm Diosynth Biotechnologies (formerly Avecia) as CMO to provide process development and cGMP manufacturing
• By establishing a deep and intimate collaboration, Fujifilm Diosynth helped ThromboGenics navigate through validation to successful and timely USA and EU approvals
• Many lessons were learned on route that can help other biotech and pharma companies making the same journey
• This presentation by programme leaders from Fujifilm Diosynth and ThromboGenics will seek to share aspects of this learning and show how the story unfolded

• Successfully upscaling single-use UPS systems
• Understanding the cost implications of using single use systems

• The smart way to optimise polishing steps in downstream processing
• Virus and contaminant clearance strategies; safety and robustness meet economically attractive solutions
• Polishing operations: Understand the impact of ligand chemistries and membrane surface modification
• The Orthogonal concept: Regulations request a minimum of two independent methods for Virus Reduction Steps - Find out about your options within current state-of the art technologies
• Learn from case studies of global players

Successfully applying productivity strategies from early development, clinical material supply through to process validation and production

• Case study examples of productivity improvements from early development, clinical material supply until process validation and production
• Implementing robust process improvements at commercial scale by using opex techniques

A novel high throughput fed-batch process development approach 

• Exploring the use of 96 deepwell plates and micro-scale bioreactors for fed-batch process development
• How to quickly improve process performance using media and feed blending approaches
• How to screen factors that affect Critical Quality Attributes

• Achieving higher titres in DSP by using customising technologies

• Successfully adapting screening technologies to the product’s needs to obtain better results

• Reducing material and labour costs during DSP by using analytical technologies
• Efficiently screening resins and conditions prior to up-scaling to chromatography

• Using efficient production processes to streamline developmental procedures and shorten developmental timelines
• Creating platform approaches to speed up products from clinic to market
• Understanding how to create a robust proof of concept
• Successfully dealing with late stage challenges

Successfully identifying the optimumsingle-use bioreactors from R&D to manufacturing

• Understanding how to define and process optimisation parameters and scale-up
• Efficiently using single-use bioreactors for mammalian cell-culture, vaccine and antibody production
• Speeding up tough processes by selecting the most suitable single-use bioreactors

Successfully applying QbD to DSP to enhance quality and comparability

• Understanding how to sustain QbD from tech transfer to commercialisation of proteins
• Successfully setting out key processes parameters for down stream processes
• Efficiently linking raw material attributes and process parameters to CQA

 Using life cycle management to speed up development processes and reduce the risk of failures

• Efficiently simplifying tech transfer processes to lead cost effect processes
• Improving awareness to gain insights, leverage and structure process information
• Utilising the latest QBD initiatives to build a toolset that is required for an efficient lifecycle management process
• Understanding how to structure and process vital information right from the beginning

Successfully overcoming the challenges in developing bioprocess for live-virus vaccines

• Understanding the alternatives to generating live virus vaccines
• Implementing key steps of bioprocess development

Successfully obtaining higher yields in DSP by using high performance anion-exchange chromatography (HPAC)

• Designing an optimum protein purification system by implementing HPAC processes
• Improving DSP by carefully carrying out individual steps 

Successfully meeting product quality and consistency in both tech transfer and scale-up processes

• Meeting tough regulatory criteria in a scale up process
• Using risk based control strategies to have a successfull tech transfer and up-scale process

Successfully using CHO genome data to enhance protein expression and secretion by characterising the most optimum clones

• Efficiently generating high yields of protein by selecting the productive CHO clones
• Identifying the genes that enhances protein production and secretion
• Improving protein yield drastically to 5-7g/l by using technological
• Successfully genetically modifying CHO cells

Evaluating new methodologies to eliminate viruses in DSPs

• Efficiently eradicating contaminants by designing specific filters to target specific viruses 
• Understanding how to measure the particle size profile by using mathematical modelling to predict how viruses will be distributed
• Successfully using viral clearance technologies such as virus filtration system in a production facility

Enhancing productivity by using cross-functional work including the quality organisation 

• “Breaking up” with traditional roles and responsibilities
• Dare to delete work that is not value adding
• Implementing one planning and follow-up system

Using change execution analysis to initiate change with small volume products 

• As patents are running out, biotech companies are investing specialised medication therefore they need to implement lean principles to stay profitable
• Understanding how to implement quick changeover method and lean approaches
• Efficiently investing the optimum equipment for small volume products