Authors


Graham A. McGibbon

Latest:

Applying QbD in Process Development

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.


Sanjivanjit K. Bhal

Latest:

Applying QbD in Process Development

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.


Andrew Anderson

Latest:

Applying QbD in Process Development

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.


Carolina Diaz Quijano

Latest:

A Multifunctional Mineral Excipient

Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.


Hildegard Bruemmer

Latest:

Early Efforts Identify Unstable APIs

Forced degradation tests, conducted in early development stages, can provide insight into degradation pathways and products of a drug substance.


Wolfgang Schiemenz

Latest:

QbD: Improving Pharmaceutical Development and Manufacturing Workflows to Deliver Better Patient Outcomes

Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.


Michael Larson

Latest:

Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better

Traditional project decision-making is compared with a QbD approach.


Christopher J. Murray

Latest:

Industrializing Design, Development, and Manufacturing of Therapeutic Proteins

The authors discuss various approaches and related issues, including production of difficult-to express proteins using cell-free expression systems, scalability of protein expression, and site-specific chemical modifications.


Valere Logel

Latest:

Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.


Stephane Rault

Latest:

Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.


Aurelie Emond

Latest:

Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.


Kenneth C. Waterman, PhD

Latest:

Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.


Mark Florez

Latest:

Why Bottles with Desiccant Outperform Foil-Foil Blister Packaging

While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.


Joanne Sullivan

Latest:

How to Get the Most from Regulatory Outsourcing

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.


Philip Smith

Latest:

How to Get the Most from Regulatory Outsourcing

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.


Bettina Goldberg

Latest:

How to Get the Most from Regulatory Outsourcing

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.


Poonam Sheth

Latest:

Targeting the Lungs

Considerations in selecting a dosage form for drug delivery to the lungs.


Matthew T. Marmura

Latest:

Targeting the Lungs

Considerations in selecting a dosage form for drug delivery to the lungs.


Ad Gerich

Latest:

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.


Jorina Verhoog

Latest:

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.


Michiel Damen

Latest:

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.


Willy Verhoeven

Latest:

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.


Sai Prasanth Chamarthy

Latest:

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.


Rut Besseling

Latest:

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.


Thomas Peglow

Latest:

Cleaning Validation for APIs

The industry needs a single standard cleaning limit at 25 mg/m2.


Capsugel – Now a Lonza Company

Latest:

Enabling Formulations of Poorly Absorbable Drugs with Capsule Solutions

Two Airings! * NA, EMEA, LATAM: Tuesday, May 18, 2021 at 11am EDT |8am PDT| 4pm BST| 5pm CEST and APAC: Tuesday, May 25, 2021 at 4pm JST| 3pm CST| 5pm AEST| 12:30pm IST* Learn more about possible solutions to help overcome the challenges of formulating poorly absorbable APIs with different oral dosage forms. *On Demand Until May 25, 2022*




Ashok Kumar

Latest:

Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better

Traditional project decision-making is compared with a QbD approach.


ILC Dover

Latest:

The Future of Sterile Manufacturing is soloPURE™

Meet the soloPURE™ flexible aseptic isolator, a cost-effective closed-barrier system for sterile manufacturing that provides a closed Grade-A, aseptic environment for fill finish activities requiring positive and negative pressures.