2nd HPAPI Handling & Manufacturing Summit 2022 - uventia

2nd HPAPI Handling & Manufacturing Summit 2022

2nd HPAPI Handling & Manufacturing
Event Details


HPAPIs (highly potent active pharmaceutical ingredients) are potent molecules that may aid in the treatment of serious and life-threatening illnesses and disorders. At a certain time, due to their great potency, these compounds pose a risk to the production facility’s staff. On the one hand, special efforts must be taken to ensure operator safety, while on the other hand, great product quality is also necessary.

Industry leaders, occupational toxicologists, and containment experts will share the most recent insights affecting the HPAPIs handling environment at our online meeting. Complex highly potent compound projects will be discussed, with a focus on safe and secure potent API processing, process development and scale-up, occupational health risks and toxicological assessment, advancements in isolators and facilities to reduce exposure risk, containment strategies and cross-contamination risk management, and more.

Ultimately, safe and efficient HPAPI handling demands a thorough assessment of a variety of parameters. Keep an eye out for more advances in HPAPI manufacturing and processing this upcoming September!


  • Occupational Exposure Bands (OEBS).
  • Determining HBEL for HPAPI – a focus on OEL.
  • HPAPI, how modeling the exposure can help setting adapted handling requirement.
  • Strategic elements within HPAPI projects.
  • Unique development of challenges with a natural product derived material.
  • Manufacturing of oncological products by a CDMO.
  • Integrated approach to technology transfer and scale up.
  • Toxicology assessments for HPAPI manufacturing: what constitutes quality in HBEL reports?
  • Verification and monitoring of containment performance.
  • Science and risk-based cleaning validation using ASTM standards.
  • Design & construction of HPAPI labs.
  • Integrating EHS into the product development process.
  • Are you protecting your workers during HPAPI manufacturing?


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] 2nd Annual HPAPI Handling & Manufacturing Summit 2022

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

Speaking Companies

Previous Event
HPAPI Handling-Manufacturing Summit
[•REC] - €345
September 29, 2021
10:00 am

● LaboratóRio Edol – Produtos FarmacêUticos S.A. ● Hameln Rds S.R.O. ● HAS Healthcare Advanced Synthesis SA ● Research Center Pharmaceutical Engineering GmbH ● Esteve Quimica, S.A. ● Sterling Pharma Solutions Ltd ● Douglas Pharmaceuticals Ltd ● Sanofi ● Wildlife Pharmaceuticals (Pty) Ltd ● Merck KGaA ● Toxiconsultant S.L ● Gedeon Richter Plc. ● Shaoxing Hantai Pharmaceutical Co., Ltd. ● Lamda Laboratories SA ● Hellenic Breweries Of Atalanti S.A. ● Maprimed S.A. ● Glatt Pharmaceutical Services GmbH ● SEQENS ● SANOFİ ILAC SAN. TIC. A.Ş. ● Evotec ● Sanovel Pharmaceutical ● Teva Pharmaceuticals Inc ● PharmaLex India Pvt. Ltd. ● Pharmascience Inc. ● Dr Abidi Pharmaceutical ● EUROAPI ● Ferring Pharmaceuticals ● Angelini Pharma ● Hammersmtih Medicines Research ● Cehtra ● Delpharm Reims ● Recordati S.P.A. ● Delpharm Poznan ●HPAPI Project Services Limited ● Halozyme ● Scale Up Solutions; LLC ● SafeBridge Europe ● Lonza ● BSP Pharmaceuticals S.P.A. ● CPCI™ ● Piramal Pharma Solutions

● 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

Speaker Board
Sebastian Joseph
Director Head of Toxicology
Guillaume Moussette
Industrial hygienist
Thomas R. Evans
Director EHS & Facilities Management
Jay L. Brown
Associate Director of EHS
Piramal Pharma Solutions
Hani El Kassas
Program Manager
Merck KGaA
Andrew Walsh
William A. Hawkins
Managing Toxicologist
SafeBridge, Europe
Lisa Wiesner
Fabio Zenobi
EHS Director
BSP Pharmaceuticals S.p.A.
Tara Dennis
Occupational Hygiene Manager
SafeBridge, Europe
Justin Mason-Home
HPAPI Project Services Limited
Rich Arnett
Manager, Industrial Hygiene & Toxicology
Pharmascience Inc.
Jack Brown
Scale up Solutions; LLC

Summit Agenda

◆  What is an OEB.

◆  A brief history of OEBs.

◆  The use of occupational banding systems.

SafeBridge Europe, UK

◆  What are HBEL?

◆  What defines HPAPI?

◆  Concept for default vs. calcualted OEL for HPAPI.

Lonza, CH

◆  Opperational Condition and Risk management Measures from REACH regulation (OC&RMM).

◆  Exposure modeling (ART tool).

◆  Adapt your safety handling to your API mixture.


◆  Strategic HPAPI business decisions.

◆  Key HPAPI project elements – Hazard, Risk and Control.

◆  Practical Roll Out of HPAPI projects.

HPAPI Project Services Limited, UK

◆  What are some of the unique challenges when using a natural product as the starting material and how to overcome some of the challenges. What tools can be used and what systems may need to be investigated.


◆  New chemical entities have their own unique challenges, since many times may use new chemistries and potential energic materials. The task of defining what is the definition of a API starting material and where does the point of handling these materials as potent.

Scale up Solutions; LLC, USA

◆  New Product Introduction into a shared facility: Risk Assessment.

◆  Case Study: ADC Manufacturing.

◆  Waste & Wastewater management.

BSP Pharmaceuticals S.p.A., IT

◆  Development of secure and scalable processes.

◆  Dealing with containment setbacks in scale up of HPAPIs.

◆  cGMP manufacturing at pilot scale.

◆  Transfer of the process to the manufacturing facility.

Pharmascience Inc., CA

◆  PDE/ADE and OEL basic concepts.

◆  Regulatory expectations on scientific quality of HBEL assessments.

◆  What to look for while deciding your toxicology service provider.

◆  How to differentiate good quality and poor quality HBEL reports.

Pharmalex India Pvt. Ltd., IN

◆  Why do we need to assess containment performance.

◆  Guidance on carrying out a containment performance assessment.

◆  Interpreting results.

SafeBridge Europe, UK

◆  Importance of ASTM Pharmaceutical Standards.

◆  Cleaning Process Development and Validation Standard.

◆  HBEL Standard.

◆  Visual Inspection Standard.

◆  The Quantitative Measurement of Risk using Toxicity, Process Capability and Detectability Scales.

◆  The Shirokizawa Matrix.


◆  Containment Strategy for HPAPI.

◆  Designing for Single Digit ng (OEL levels, <10 ng/m3).

◆  Significant amounts of flammable material (XP environment).

◆  Regulatory requirements around biological burden risk and the regular cGMP requirements (ISO 8 rooms).

Merck KGaA, Darmstadt, DE

◆  Integrate EHS early in the process.

◆  Having the right team at the table.

◆  Information needs to ensure a smooth process.

◆  Resolving OEB and OEL disagreements with clients.

◆  Who pays containment and waste costs.

Piramal Pharma Solutions, USA

To create the necessary safe environment, there are three main areas of initial consideration:

◆  Design & Installation Considerations

o Key steps in preparing an effective user requirement specification plan to install an HPAPI fill line.

◆  Best Industrial Hygiene Practices vs. Good Manufacturing Practices

o Quantifying employee exposure when working with very low OEL compounds.

o Maintaining strict ISO 5 production and still isolating product from workers (e.g. positive pressure isolator vs. negative containment).

o Equipment cleaning and preventive maintenance.

o Training employees to be subject matter experts regarding HPAPI handling.

o Ensuring vials are safe to handle and transfer after the filling operation.

◆  Characterizing, Challenging, & Verifying Isolator Performance 

o How to create a complete commissioning plan that will give operators and EHS staff the tools and confidence to develop safe and effective operating procedures.

Halozyme, USA

Event Details