Biomanufacturing

Biologics Manufacturing, Tuesday 19 September 2017

REALISING INDIA'S PHARMA VISION 2020

08:50

Organiser’s welcome remarks

Vikas Dandekar
08:55

Chairman’s opening remarks

Suja Chandy
09:00

Pharma Vision 2020, How close are we to the goal?

The Government of India unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacturing. The Indian pharma market is expected to grow to US$ 55 billion by 2020. With the government implementing many new initiatives in its stride toward Pharma Vision 2020, how close are we to achieving it?
Panel discussion
09:30

Boardroom panel: Creating a robust ecosystem for pharma in India

India is poised to become a top 5 global pharmaceutical hub by 2020. But in order to achieve this, there’s work to be done, to develop a successful ecosystem. Key stakeholders including the government, pharma, regulators and investors need to work closely together to build it. In this panel, we gather them to explore how, as we explore issues including:
 
  • How will the creation of new pharma clusters across India help enhance the ecosystem?
  • How is the Indian government playing an active role to help build up the ecosystem? (Building infrastructure, funding of incubators and accelerators, mission mode programmes)
  • Should a robust and sustainable ecosystem be centred around academic institutes to increase collaboration?
  • What are some existing models which India can emulate? (Boston,SF Bay area, Singapore, BioValley)
  • Is achieving that too idealistic? How far is India from achieving that?
10:30

Speed Networking

11:00

Networking Refreshments & Exhibition Visit

Rodrigo Blanco Zamora
11:30

LatAm: Investment, market access, and reimbursement issues in this key regional growth market

  • Highlighting the potential within the LatAm pharmaceutical markets
  • Regulatory reforms and deregulation in Mexico
  • Updates on the practical implementation of Mexico as a regional reference agency for other LatAm countries
  • Advantages for the registration of biologic drugs in LatAm
  • What it takes to successfully launch biologics in LatAm and their various reimbursement infrastructure

Roundtable discussion

11:50

Table 1: Technology road mapping and industry collaboration in biologics manufacturing

11:50

Table 2: Single-Use Technology - qualification testing for the films used in flexible bags (BioProcess Containers)

11:50

Table 3: Innovative market access, RWE and HEOR strategies for emerging and mature products in India

12:30

Networking Lunch & Exhibition Visit

Dhaval Tapiawala
Biologics Manufacturing
13:50

Chair’s opening remarks

Future of biologics manufacturing in India

Mehul Patel
Biologics Manufacturing
14:00

Automation to reduce human error in India’s biologics manufacturing

  •     Identifying prevalent human errors in manufacturing processes
  •     Exploring possible automation solutions to eradicate
  •     Analysis on productivity improvements
  •     How does increased automation improve GMP compliance of the future of Biopharmaceuticals and how to achieve EU GMP compliance 
Solomon Alva
Biologics Manufacturing
14:20

A step towards continuous processing: Downstream perspective

  •     Integrating continuous cell culture and purification 
  •     A case of multi-column chromatography for capture and polishing steps
  •     Current view of challenges for implementation
Abhinav Shukla
Biologics Manufacturing
14:40

Highly accelerated platforms for mAb and next generation mAb development

  •     Key elements of a mAb platform enabling gene to GMP in 9 months
  •     High throughput process development tools for developing next generation mAbs
  •     Challenges encountered with these novel types of molecules
  •     Rapid and streamlined process characterization and validation studies to enable BLA/MAA filings for breakthrough therapies and biosimilars 
15:00

Networking Refreshments & Exhibition Visit

Process Development

Janani Kanakaraj
Biologics Manufacturing
15:30

Best practices in scale up and technology transfer

  •     Creating the considerations for smooth scale up and technology transfer
  •     Analysing the new technologies available
  •     Case Study: Practical challenges in scaling up a Biosimilar process 
Annu Uppal
Biologics Manufacturing
15:50

Monoclonal antibody characterization: routine and advanced workflows

  •     Simpler and faster solutions for Routine mAb characterization 
  •     Exploiting SWATH, the data independent strategy for the identification of low abundance critical quality attributes (CQAs)
  •     Charge variant analysis; utilizing the separation power of capillary electrophoresis with mass spectrometry.
  •     Exploring MS based strategy as an orthogonal means of HCP analysis.
Kumar Gaurav
Biologics Manufacturing
16:10

Determining optimum conditions for scaling down models in downstream processing

  •     Making sure scaled down hardware is able to control and calibrate perimeters precisely and accurately
  •     Ensuring operational equivalence with all operational perimeters run at center of optimum range using large scale
  •     Understanding the importance of model qualification to pre determine acceptance criteria for scale down

Upstream Manufacturing

Dhaval Tapiawala
Biologics Manufacturing
16:30

Extractables and leachables testing using a Quality Risk Management approach

  • Understanding extractables and leachables for better adoption of single use systems
  • Ensuring safety of drug through determining the level of leachables throughout product life cycle
  • Case Study of implementation of standardized testing protocol
Kaumil Bhavsar
Biologics Manufacturing
16:50

Ensuring quality and stability in cell-line development

  • Avoiding animal-origin material contact through use of a serum free medium
  • Exploring ways to address the translation, secretion and cell trafficking issues
  • Evaluating glycosylation and charge heterogeneity for consistency
17:10

Networking Drinks Reception

last published: 18/Sep/17 06:35

Biologics Manufacturing, Wednesday 20 September 2017

09:00

Chair’s opening remarks

Looking to the Future

Taslimarif Saiyed
09:10

An organised approach to promoting nation-wide innovation

When it comes to encouraging innovation centers in India, the government has a more decentralised approach where states have the flexibility and funds to build individual programs and innovation centers to promote the growth of biotech hubs. However, sometimes too many cooks may end up spoiling the broth. So how do different government units truly measure the real return of investment of these expenditures, and how do stakeholders work together in organising a more united approach to instilling real innovation within India?
 
Mithua Ghosh
09:35

Is the future of medicine personalised?

With the recent advancements in the study of genomics, much progress has been made creating medicines tailored specifically to an individual’s conditions and symptoms. Are we entering a new era of medicine with personalized medicine? To what extent are payers, providers, systems, physicians and patients ready for the change? How will digital technologies and solutions play into the vision of personalised medicine? What are the remaining challenges in making the vision of personalised medicine a reality?
Bindu Ajit
10:00

Creating the workforce of the future: A case study on Biocon Academy

Biotechnology is a relatively young field in India, and it can sometimes be challenging to source for helpful manpower as real talented young individuals often get allured by overseas opportunities. This case study will share Biocon’s success story in building an academy with financial support and assistance to help young graduates to explore more options in their career, whilst growing essential talents to support the local ecosystem in India.
 
10:25

Networking Refreshments & Exhibition Visit

Sanghamitra Bhattacharjee
Biologics Manufacturing
11:15

Chair’s opening remarks

Downstream Manufacturing

Hemant Dhamne
Biologics Manufacturing
11:20

Strategies for overcoming the downstream bottleneck for Cell and Gene Therapy (CGT)

  •     Identifying the key areas of bottleneck in downstream processing (harvesting, washing, cell concentration, formulation, final fill/finish, and preservation)
  •     Balancing between high specificity and high throughput of downstream platforms for maximum efficiency
  •     Exploring ultra scale-down tools to better predict large scale downstream processing steps 
Rahul Fadnis
Biologics Manufacturing
11:45

Viral safety testing and clearance in biopharma industry

  •     Overview of viral contamination events in the Biologics Industry
  •     Consequences of the viral contamination in Biologics drugs
  •     Importance of viral risk mitigations in ensuring safety of drugs
  •     Regulatory expectations for viral safety in Biologics
  •     Syngene’s  support towards meeting viral safety requirements of the Biologics manufacturers
13:00

Networking Lunch & Exhibition Visit

Biologics Manufacturing
13:25

Chair’s opening remarks

Quality & Compliance

Panel discussion
Biologics Manufacturing
13:30

Ensuring uniformity of GMP inspections in biologics manufacturing

Countries across the globe are concerned about the safety and efficacy of the drugs supplied. As India expands its biologics supply globally, there is an increased emphasis in ensuring uniformity in inspection requirements for drugs manufactured in India. This panel discusses how global regulators such as US FDA, EMA can work closer together with CDSCO in ensuring uniformity in GMP inspections.
  • Overview of India’s inspection landscape and updates
  • Understanding the differences and overlaps in current standards
  • Exploring ways for various regulators to work closer together, including more combined inspections for newly recruited CDSCO inspectors
Dr Akshay Goel
Biologics Manufacturing
14:10

Scaling up Vaccine Production: Process Validation

  • Demystifying process validation
  • Process validation deliverables
  • Application in vaccine industry: Post Approval change
  • Application in Pharma industry: Warning letter

Analytical Development

Sanghamitra Bhattacharjee
Biologics Manufacturing
14:30

Analytical Development of novel immuno-oncology (IO) drugs

  •     Exploiting various modes of biological IO treatments
  •     Efficacy assays and predictive toxicology for target validation
  •     Analytical process development and CMC strategies for novel I-O drugs
Anita Krishnan
Biologics Manufacturing
14:50

Practical considerations for establishing analytical similiarity in biosimilars

  • Assessment of critical quality attributes (CQA) and evaluation of tiers
  • Using risk management principles to supplement statistical approaches for assessment of analytical similarity for CQAs
  • Ranking of quality attributes based on potential impact on activity, PK/PD and immunogenicity
Dipak Thakur
Biologics Manufacturing
15:10

Development of liquid chromatography-Mass spectrometry (LC-MS/MS) based methods for pharmacokinetic and toxicokinetics study of biologics

  • Advantages of LC-MS/MS based methods over ELISA methods
  • Parameters to be considered while developing LC-MS based methods for pK/tK  study
  • Challenges during method development and validation: requirement of stable isotope labeled internal standards

Close of Biopharma India 2017

last published: 18/Sep/17 06:35