HPAPI Day 2- Thursday 2nd November 2017

Containment and Handling

Jeff Parry
09:10

Case study – bringing contained ways of working to an oral solid dosage form pilot plant

  • Containment problems and solutions for a mix of new and old equipment
  • Altering the scientist’s mindset
  • 3 years on…
Sylvain Querol
09:30

Containment Technologies and adapting solutions for Highly Potent APIs

  • What containment strategy to put in place depending on scale and potency of compounds
  • Key aspects of process consideration when implementing containment
  • Have we reached the limits of containment solutions? Looking to the future.
Stefano Butti
09:50

Case Study: Process equipment integration into HPAPI’s containment systems –from R&D to production scale

  • Efficient Containment strategy selection to meet product and process specification
  • Project Development critical phases
  • Fully integrated R&D, Pilot and Production Unit down to nanograms Containment Level
  • New challenges and solutions
Ildiko Ziegler
10:10

Evaluation of cross contamination risk in shared facilities: case studies on steroid hormone API endproducts and cytotoxic drugs

  • Toxicological approach and cross contamination guidelines
  • Complexity in risk analysis of cross contamination and some measures
  • Case studies: hormonal steroid API production and manufacturing parenteral cytotoxic products
10:30

Networking Refreshments

Regulatory Updates

Andreas Schreiner
11:30

Novartis case study: cleaning requirements for highly active substances

  • Cross-contamination risk and mitigation according to new EMA Guidelines
Ester Lovsin Barle
11:50

Applying EMA health based exposure limit (HBEL) guidelines

·         Expectations based on the EMA guideline and Q&A document
·         How to operationalise the guideline
·         How do the European and US guidelines differ?
Marc Suter
12:10

Requirements for the manufacturing of highly potent aseptic product in shared facilities

  • Safety through aseptic Isolator Technology
  • How to achieve aseptic conditions within Isolators
  • How to  for manufacturing highly potent, highly hazardous substances in an aseptic Isolator
Martin Axon
12:30

Evaluating CMO Ability to safely handle potent active pharmaceutical materials

  • A comprehensive metric to assess CMO capability across key areas
  • Common findings at pre-assessment
  • Maintaining capability to safely handle potent materials
  • Programme improvements over time
12:50

Networking Lunch

ADCs and New Molecules

Sir Gregory Winter
14:00

Bicycles - a paradigm shift in pharmaceutical drugs

  • New platform based on repertoire technology
  • Peptide conjugates with toxic drugs for treatment of cancer
Sir Gregory Winter, Master, Trinity College Cambridge, University of Cambridge
Olindo Lazzaro
14:20

Case study from Abbvie: IH/Containment improvement strategy

  • Containment improvement Targets and LRP
  • Containment in NPI Tech Transfer
  • IH exposure risk assessment metrics
  • Team Approach - Community of Practice
  • Banding system and engineering standards
Roger Beerli
14:40

Anthracycline-based antibody drug conjugates with potent immune-stimulatory functions

  • Site-specific conjugation using sortase enzyme (SMAC™-Technology), yielding homogenous ADCs
  • Highly potent payload, providing access to difficult-to-address targets
  • Anthracycline-based payload with attractive IO properties
Karoline Bechtold Peters
15:00

Challenges and solutions of manufacturing Antibody Drug Conjugate Drug product – facility design, multi-product use and application of disposables

  • Appropriate aseptic facility design
  • Rationale and procedures for multi-product use (ADCs and non-ADCs)
  • Options for disposables
15:20

Networking Refreshments

Equipment and facility Design

Ulf Johansson
16:00

Dispensing and sampling of potent APIs – the AZ approach

  • How is the AstraZeneca Swedish facility meeting increased demands for highly potent drugs?
  • A case study of their latest method for dispensing of toxic substances
  • Use and monitoring of containment screens, flexible isolators and hard isolators
Aurore Perzyna
16:20

Conceptual Design of new HPAPI facilities: from lab to pilot scale

  • How to define our target?
  • Which strategy of containment?
  • Next steps before building these new facilities
Rainer Nicolai
16:40

Single use packaging of high potent bulk material

  • FIBC-technology for high potent API bulk material
  • Adopting the packaging to process needs 
  • Future possible trends in packaging of high potent bulk material
17:00

Chair's wrap up discussion

17:15

End of Conference

last published: 09/Oct/17 10:35 GMT