Sandoz Product Development

Nanoliposomal Irinotecan: SOS determination by 1H NMR spectroscopy
Hearts are made to be cut - Applying "heart-cutting" technique for simultaneous determination of trace amounts of benzene and benzaldehyde
Roxadustat L-Proline – Sandoz´ first co-crystal in full development
Smart statistical approach for in vitro bioequivalence testing of micellar products to overcome regulatory challenges
Ready-to-use (RTU) Azacitidine
Cyclophosphamide LIVI: Rejuvenating an old player
Excipient compatibility studies: (in)convenient approach to ensure drug product stability?
Liposomal amphotericin B: reducing drug toxicity by liposomal encapsulation
Marathon journey: introducing digital imaging to full-scale high-shear granulation processes
Single method for 24 Elements by ICP-MS
CD go-guidance tool: concept to reality
Evaluating Viscoelastic Modulus Curves for Rheology Studies in Semisolid Generic Drug Product Development
Modern experimentation using Customized Design of experiments (Computer generated designs) for Formulation optimization of Obeticholic acid film coated tablets 25mg
How to perform method development and optimization in ten days?
3D Printing – Towards Medicine Personalization
Systematic Development of Empagliflozin (EMPA) Amorphous Solid Dispersion (ASD) using Conventional Spray Granulation Process
Unique High throughput multivariate method for evaluation of oncology products
Formulation strategy for the development and optimization of stable Binimetinib film coated tablets using Amorphous and Hygroscopic API of Binimetinib
Use of In-vitro dynamic gastrointestinal models for better in-vivo predictions
Statistics and Particle size selection: Special emphasis on Polymodal distributions
Alternate Approach for Respiratory Clinical Endpoint Bioequivalence Studies: Functional Respiratory Imaging
IVIVC Collaboration Between SDC INHY and Kundl: Leveraging Historical Bioequivalence Data for Product Development and Decision of Omitting Pilot Bioequivalence Study
High throughput Bioanalysis: Key for eFTF complex project
A Deeper Insight Into Degradation of Venetoclax Along With Implementation of Analytical Quality by Design (AQbD)
Palbociclib capsules: Evaluation and Development of a digital twin approach for optimization and scale up
Preclinical development of complex generics
Development of a clinically equivalent AirBuFo® High strength dry powder inhalation product within a year time frame to support commercial viability of AirBuFo® Mid strength & Sandoz respiratory strategy
Rheology by Design - Design Space exploration of the 3D matrix of solid dosage forms
Leaving Excel finally behind - Level C IVIVC in WinNonlin
Silicone nasal cast study of nasal sprays deposition
Scientific and regulatory lessons learned in co-developing a drug using the 505(b)(2) pathway: A case study of baclofen intravenous infusion (with Orphan Drug Exclusivity)
The Power of in Silica – stabilizing amorphous solid dispersions
Scientific Advice - Challenging Health Authorities to Reach the Sky above the Current Regulation
Successful bioequivalence study based on inconclusive comparative dissolution results
Accelerated mindset efficiently embedded in regulatory strategies ensuring first-to-market launches
Process development and scale-up for Avibactam sodium Form C
Application of Accelerated Predictive Stability (APS) Studies for Prediction of long-term stability based on accelerated short-term stability testing using Dynochem
Neratinib FCT 40 mg – prototype in 5 months, many challenges, one goal – robust product
Gx development of Ellipta® platform – Powder Filling and Packaging Development of Complex Dry Powder Inhalation Products
Successful rescue of a PK similarity study of Erelzi from COVID-19 pandemic
Acc Gx: Is parallel PBE study design appropriate for all products?
Ready to Use and Ready to Administer Products for the US Market
Sandoz Value Creation via US BD&L Pipeline
Center of Excellence (CoE) for evaluation of mutagenic impurities (MIs): Sandoz Product Development response to ensure safe and high quality drug products!
Characterization of generic synthetic peptide drug products to meet the US regulatory requirement
Development of Sodium Zirconium Cyclosilicate (NaZS-9) production process
Critical Insights on the Conception of Microenvironment pH Based Forced Degradation Studies on the Drug Substance in Solid State
Effect of patient use study with simulated patient use – a surrogate approach
Effect of gastrointestinal transit on micro-environmental pH inside HPMC matrix tablets –in vitro study
Physiologically Based Biopharmaceutics Modeling – a rescue medicine for life cycle management
Conceptualization & execution of a product understanding roadmap to realize Gx to Ellipta® platformproducts to support respiratory strategy of Sandoz

Nanoliposomal Irinotecan: SOS determination by 1H NMR spectroscopy

Hearts are made to be cut - Applying "heart-cutting" technique for simultaneous determination of trace amounts of benzene and benzaldehyde

Roxadustat L-Proline – Sandoz´ first co-crystal in full development

Smart statistical approach for in vitro bioequivalence testing of micellar products to overcome regulatory challenges

Ready-to-use (RTU) Azacitidine

Cyclophosphamide LIVI: Rejuvenating an old player

Excipient compatibility studies: (in)convenient approach to ensure drug product stability?

Liposomal amphotericin B: reducing drug toxicity by liposomal encapsulation

Marathon journey: introducing digital imaging to full-scale high-shear granulation processes

Single method for 24 Elements by ICP-MS

CD go-guidance tool: concept to reality

Evaluating Viscoelastic Modulus Curves for Rheology Studies in Semisolid Generic Drug Product Development

Modern experimentation using Customized Design of experiments (Computer generated designs) for Formulation optimization of Obeticholic acid film coated tablets 25mg

How to perform method development and optimization in ten days?

3D Printing – Towards Medicine Personalization

Systematic Development of Empagliflozin (EMPA) Amorphous Solid Dispersion (ASD) using Conventional Spray Granulation Process

Unique High throughput multivariate method for evaluation of oncology products

Formulation strategy for the development and optimization of stable Binimetinib film coated tablets using Amorphous and Hygroscopic API of Binimetinib

Use of In-vitro dynamic gastrointestinal models for better in-vivo predictions

Statistics and Particle size selection: Special emphasis on Polymodal distributions

Alternate Approach for Respiratory Clinical Endpoint Bioequivalence Studies: Functional Respiratory Imaging

IVIVC Collaboration Between SDC INHY and Kundl: Leveraging Historical Bioequivalence Data for Product Development and Decision of Omitting Pilot Bioequivalence Study

High throughput Bioanalysis: Key for eFTF complex project

A Deeper Insight Into Degradation of Venetoclax Along With Implementation of Analytical Quality by Design (AQbD)

Palbociclib capsules: Evaluation and Development of a digital twin approach for optimization and scale up

Preclinical development of complex generics

Development of a clinically equivalent AirBuFo® High strength dry powder inhalation product within a year time frame to support commercial viability of AirBuFo® Mid strength & Sandoz respiratory strategy

Rheology by Design - Design Space exploration of the 3D matrix of solid dosage forms

Leaving Excel finally behind - Level C IVIVC in WinNonlin

Silicone nasal cast study of nasal sprays deposition

Scientific and regulatory lessons learned in co-developing a drug using the 505(b)(2) pathway: A case study of baclofen intravenous infusion (with Orphan Drug Exclusivity)

The Power of in Silica – stabilizing amorphous solid dispersions

Scientific Advice - Challenging Health Authorities to Reach the Sky above the Current Regulation

Successful bioequivalence study based on inconclusive comparative dissolution results

Accelerated mindset efficiently embedded in regulatory strategies ensuring first-to-market launches

Process development and scale-up for Avibactam sodium Form C

Application of Accelerated Predictive Stability (APS) Studies for Prediction of long-term stability based on accelerated short-term stability testing using Dynochem

Neratinib FCT 40 mg – prototype in 5 months, many challenges, one goal – robust product

Gx development of Ellipta® platform – Powder Filling and Packaging Development of Complex Dry Powder Inhalation Products

Successful rescue of a PK similarity study of Erelzi from COVID-19 pandemic

Acc Gx: Is parallel PBE study design appropriate for all products?

Ready to Use and Ready to Administer Products for the US Market

Sandoz Value Creation via US BD&L Pipeline

Center of Excellence (CoE) for evaluation of mutagenic impurities (MIs): Sandoz Product Development response to ensure safe and high quality drug products!

Characterization of generic synthetic peptide drug products to meet the US regulatory requirement

Development of Sodium Zirconium Cyclosilicate (NaZS-9) production process

Critical Insights on the Conception of Microenvironment pH Based Forced Degradation Studies on the Drug Substance in Solid State

Effect of patient use study with simulated patient use – a surrogate approach

Effect of gastrointestinal transit on micro-environmental pH inside HPMC matrix tablets –in vitro study

Physiologically Based Biopharmaceutics Modeling – a rescue medicine for life cycle management

Conceptualization & execution of a product understanding roadmap to realize Gx to Ellipta® platformproducts to support respiratory strategy of Sandoz