HPAPI Handling & Manufacturing Summit 2021 - uventia
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HPAPI Handling & Manufacturing Summit 2021

HPAPI Handling-Manufacturing Summit
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CONFERENCE OVERVIEW

Highly potent active pharmaceutical ingredients (HPAPIs) are known as powerful compounds that might help to treat severe and life-threatening conditions and diseases. At the same time, due to their high potency, these compounds have potential risks for the personnel in the production facility. Special precautions need to be taken to ensure the safety of operators and on the other hand high product quality is also required.

At our online meeting industry leaders, occupational toxicologists and containment experts will present the latest insights affecting the HPAPIs handling landscape. We will talk about complex highly potent compound projects focusing on safe and robust potent API processing, development and scale-up of processes, occupational health risks and toxicological assessment, advancements in isolators and facilities to minimize exposure risk, containment strategies and management of cross-contamination risks and more.

Inevitably, safe and efficient HPAPI handling requires a careful evaluation of multiple factors. Explore how pioneering pharma companies are approaching HPAPI development and processing this coming September.

WE WILL TALK ABOUT

  • Handling HPAPIs safely: factors affecting containment performance.
  • Assessment of co-manufacturability and cross-contamination risk: pharmaceutical and cosmetic semi-solids.
  • How to handle HPAPIs within chemical development.
  • Process equipment special design for HPAPI containment system integration.
  • Risk-based cleaning validation.
  • Lifecycle management of analytical methods for cleaning verification support.
  • HPAPI facilities and process design.
  • Worker and patient safety in the production of highly potent APIs.
  • Occupational exposure bands (OEBs).
  • Practical steps for delivering HPAPI projects.
  • Scale-up challenges with HPAPIs.
  • CMO strategies, outsourcing and HPAPIs supply chains.

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

  • HPAPI Manufacturing/ API Manufacturing/ Compounds Manufacturing
  • Occupational Toxicology/ Industrial Hygiene / EHS
  • Process Engineering/ Process Development/ Process Scale Up
  • Containment/ Cross Contamination/ Cleaning Validation
  • Cleanroom/ Facility Design/ Isolators
  • Risk Management/ Quality Assurance/ Quality Control
  • Analytical Development/ Analytical Methods
  • CMO/ CDMO/ Outsourcing

[Agenda] HPAPI Handling & Manufacturing Summit 2021

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

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Speaking Companies

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ATTENDEES IN 2021

● A/S Grindeks ● Abdi Ibrahim Global Pharm ● AdhexPharma ● AGC Pharma Chemicals Europe, S.L.U. ● Apotex Inc. ● AstraZeneca ● Aurobindo Pharma Limited ● Bayer AG ● BioDuro-Sundia Corporation ● Biotage GB Ltd ● Biovac ● Boehringer Ingelheim ● Boehringer Ingelheim Pharma GmbH & Co. KG ● Bristol-Myers Squibb ● Cambrex Corporation ● Catalent ● Cipla Ltd. ● Cristália Prod. Quim. e Farm. LTDA ● Custom Pharma Services ● Eurofins Amatsigroup ● FAREVA Mirabel ● Farmabios SPA ● FPS Food and Pharma Systems srl ● Fresenius Kabi ● Gedeon Richter Plc. ● Glatt India Engineering Pvt Ltd ● HPAPI Project Services Limited ● Johnson&Johnson ● Kindeva Drug Delivery ● Labesfal-Laboratórios Almiro S. A. ● Merck KGaA ● MSD Ballydine ● Novo Nordisk ● Nuvisan Pharma Services ● Oakwood Laboratories, LLC. ● Olon S.p.A ● Oncomed Manufacturing a.s. ● Organon Pharma BV ● Pharmascience Inc. ● Pharmascience Inc. ● PharmaZell GmbH ● Polpharma SA ● Quay Pharmaceuticals ● RCPE GmbH ● SafeBridge Europe ● Sai Life Sciences Limited ● Sandoz GmbH ● Saneca Pharmaceuticals a.s. ● Sanofi ● Sanofi Chimie ● Sanofi-Aventis ZRT ● Scale up Solutions ● Siegfried Evionnaz SA ● STADA Arzneimittel AG ● Symeres ● Vanessa Research

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Speaker Board
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Martin Kohan
Martin Kohan
Managing Toxicologist
SafeBridge Europe
Mariann Neverovitch
Mariann Neverovitch
Sr. Manager Logistics Operations
Bristol-Myers Squibb
Butti Stefano
Stefano Butti
Head of Sales Group
F.P.S. Food and Pharma Systems
Claudia Sehner
Claudia Sehner
Senior Toxicologist
Boehringer Ingelheim Pharma GmbH
Ildiko Ziegler
Ildikó Ziegler
QA Manager
Vanessa Research
Martin Axon
Martin Axon
Senior Principal Occupational Hygienist
SafeBridge Europe
Vincenzo De Sio
Vincenzo De Sio
HPAPI Manufacturing Manager
Cristália Prod. Quim. e Farm. LTDA
Justin Mason-Home
Justin Mason-Home
Director
HPAPI Project Services Limited
Rich Arnett
Rich Arnett
Manager, Industrial Hygiene & Toxicology
Pharmascience Inc.
Fred Ohsiek
Fred Ohsiek
Principal Cleaning Process Consultant
VTI Life Sciences
Jack Brown
Jack Brown
Consultant
Scale up Solutions; LLC
Thomas Adam
Thomas Adam
Head of GQA Chemical APIs
Bayer AG
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Summit Agenda
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◆  Quantifying the performance of containment systems.

◆  Isolators, SBVs, continuous liners, proprietary systems; design and usage are the key.

◆  Factors affecting containment performance: «the data» doesn’t usually lie.

SafeBridge-TrinitySafeBridge-Trinity

SafeBridge Europe, UK
Speakers:

◆  Guidelines regarding cross contamination and toxicological approach.

◆  Complexity in risk analysis of cross contamination and some possible measures.

◆  Case study: ointments for different uses.

Vanessa-ResearchVanessa-Research

Vanessa Research, HU
Speakers:

◆  GMP-Compliance and Regulatory Environment.

◆  Cleaning of Equipment in the Manufacturing of HPAIs.

◆  Prevention of Cross-Contamination in Shared Facilities.

◆  Case study new HPAI kg facility.

BayerBayer

Bayer AG, DE
Speakers:

◆  Are all standard process equipment suitable to handle HPAPI in safe way?

◆  Process equipment critical analysis for containment system integration.

◆  Case studies.

◆  Conclusions and new challenges.

FPSFPS

F.P.S. Food and Pharma Systems, IT
Speakers:

◆  Defining and implementing risk controls.

◆  LCM approach to cleaning based on quality risk management.

◆  ICH Q9 and HBEL principles to measure the risk level.

Novo-NordiskNovo-Nordisk

Novo Nordisk, USA
Speakers:

◆  Equipment Cleaning is a critical GMP element of the Manufacturing Process. It ensures quality and safety of future batch. Cleaning Validation/verification is a measurement of the effectiveness of the cleaning process.

◆  In this presentation we will go over advantages and challenges of specific and nonspecific analytical methods based on risk assessment of the residual product.

◆  Case studies, training and qualification programs will also be discussed.

Bristol-Myers-SquibbBristol-Myers-Squibb

Bristol-Myers Squibb, USA
Speakers:

◆  Productivity vs occupational exposure in new facilities.

◆  How to design a modern HPAPI plant and related technology.

◆  Developing a process by considering the available facility and the waste management.

Cristalia-Prod.-Quim.-e-FarmCristalia-Prod.-Quim.-e-Farm

Cristália Prod. Quim. e Farm. LTDA, BR
Speakers:

◆  Regulatory background and principals for the calculation of OELs and PDEs.

◆  OELs/PDEs during development.

◆  Are OELs and PDEs required for new modalities?

◆  Considerations for implementation.

Boehringer-IngelheimBoehringer-Ingelheim

Boehringer Ingelheim, DE
Speakers:

◆  What are OEBs?

◆  History of OEBs.

◆  Use and communication of OEBs.

◆  Case studies - OEBs for compounds with limited data.

SafeBridge-TrinitySafeBridge-Trinity

SafeBridge Europe, UK
Speakers:

◆  Toxicological Hazards, Risk Assessments and Control.

◆  Key HPAPI Project Decision Making.

◆  Practical and Pragmatic HPAPI Project Roll Out.

HPAPI-Project-Services-LimitedHPAPI-Project-Services-Limited

HPAPI Project Services Limited, UK
Speakers:

◆  HPAPIs offer unique challeneges due to lack of experimentation, how do you fill the gaps.

◆  Process safety for HPAPIs needs to include both the chemical and thermal safety data, how to provide this

◆  Where to decide to start treating starting materials and intermediates as HPAPIs in a HPAPI faciltiy?

Scale up Solutions; LLC, USA
Speakers:

◆  Evaluating CMO’s ability to safely handle high potent APIs.

◆  Early-phase and late-phase CMOs vs integrated HPAPI outsourcing partner.

◆  Effective supply chain management in CMO partnerships.

PharmasciencePharmascience

Pharmascience Inc., CA
Speakers:
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