White Papers

Drug Labeling Specialist on New Pregnancy Labeling Rules

Pharmaceutical Development Group

On June 30, 2015, the new pregnancy labeling rules for prescription drug labeling took effect, marking the demise of pregnancy categories (A, B, C, D, X), in use since 1979.

Drug Labeling Specialist on New Pregnancy Labeling Rules

Sartorius Lab Instrument's Cubis® Balance Range Meets the Cleanability Requirements of the Pharmaceutical Industry

Sartorius

Balances in Satorius Lan Instrument's Cubis® product range have been designed for the demanding pharmaceutical environment, which is regulated by good manufacturing practices (GMP) and good laboratory practices (GLP).

Sartorius Lab Instrument's Cubis® Balance Range Meets the Cleanability Requirements of the Pharmaceutical Industry

Gold Nanoparticle Applications and Characterization by Nanoparticle Tracking Analysis

Malvern Instruments

Gold nanoparticles are one of the most popular and extensively researched type of nanoparticle.

Gold Nanoparticle Applications and Characterization by Nanoparticle Tracking Analysis

Characterisation Information of Critical Excipients for Sourcing Critical Raw Materials

Pfanstiehl

The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation component.

Characterisation Information of Critical Excipients for Sourcing Critical Raw Materials

ePAT Automated Lab Reactor Optimised for 24/7 Data Capture

SYSTAG Systems Technik

Systag Systems presents ePAT, a cost-effective device for automation in the laboratory.

ePAT Automated Lab Reactor Optimised for 24/7 Data Capture

The ImmunoPrecise Rapid Prime System Reduces the Immunization Stage of Hybridoma Production to 18 Days

ImmunoPrecise Antibodies

The ImmunoPrecise Rapid Prime System Reduces the Immunization Stage of Hybridoma Production to 18 Days

The ImmunoPrecise Rapid Prime System Reduces the Immunization Stage of Hybridoma Production to 18 Days

Case Study: Compaction Behaviour of Orally Dispersable Mini-Tablets

Gamlen Instruments

This whitepaper describes a method for performing dynamic powder compaction analysis and for measuring tensile fracture strength of tablets.

Case Study: Compaction Behaviour of Orally Dispersable Mini-Tablets

Orthotopic and metastasis models for preclinical efficacy testing of novel cancer drugs

Pharmatest Services

Lack of efficacy is one of the major causes of attrition in the clinical development of new compounds to treat cancer.

Orthotopic and metastasis models for preclinical efficacy testing of novel cancer drugs

Experienced Accessible Pharma Professionals and Global Regulatory Services

Pharmaceutical Development Group

PDG has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals a...

Experienced Accessible Pharma Professionals and Global Regulatory Services

An Analysis of Antibodies Using Multi-Detector SEC Methodology

Malvern Instruments

Antibodies' innate ability to direct their neutralisation attacks toward specific components in harmful agents has generated a large amount of interest within the pharmaceutical industry.

An Analysis of Antibodies Using Multi-Detector SEC Methodology

Application: Operating Reactor Systems for Process Research and Development

SYSTAG Systems Technik

In this case study, three reactor systems (FlexyCUBE 70ml, FlexyPAT 2l, and ChemTeacktor 25l) are operated on the same PC using application software FlexySys.

Application: Operating Reactor Systems for Process Research and Development

Benefits of Trehalose

Pfanstiehl

Products such as monoclonal antibodies (mAb), fusion proteins, peptides, vaccines, antibody drug conjugulates (ADC) and stem cells benefit from the stabilising effects of Trehalose.

Benefits of Trehalose

Optimising Development Resources for Efficient Product Development

SYSTAG Systems Technik

Development departments suffer from a shortage of resources and are often overburdened with administration tasks.

Optimising Development Resources for Efficient Product Development

From Gene to Finished Vial

Biovian

Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals, covering services from early development to finished vial.

From Gene to Finished Vial

Validated Metal Analysis

Pfanstiehl

Four commonly utilized carbohydrates for ptotein stabilization are Sucrose, Trehalose, Mannitol, and Maltose.

Validated Metal Analysis

Processability Assessment of Crystal Habit-Modified Active Pharmaceutical Ingredients

Gamlen Instruments

The efficiency of downstream processing of active pharmaceutical ingredients (API) can depend on their particulate properties, including size and shape.

Processability Assessment of Crystal Habit-Modified Active Pharmaceutical Ingredients

An Analysis of Polymer Branching Using GPC / SEC Methodology

Malvern Instruments

Polymer branching has been proven to have a potentially considerable impact on many physical properties of synthesised polymers, such as the disruption of crystallinity and a possible increase in single chain density and chain entanglements.

An Analysis of Polymer Branching Using GPC / SEC Methodology

Paradigm Shift Regarding API and Formulation Components

Pfanstiehl

This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limite...

Paradigm Shift Regarding API and Formulation Components

Gamlen Study: Breaking Anisotropic Rod-Shaped Particles

Gamlen Instruments

Gamlen presents a study conducted by V. Penkavova1, L. Kulaviak1, M.C. Ruzicka1, M. Puncochar, and P. Zamostny on the 'Beaking of Anisotropic Rod-Saped Particles'.

Gamlen Study: Breaking Anisotropic Rod-Shaped Particles

Softigel by Procaps Brochure

Softigel

Procaps is one of the world's largest softgel companies, specialising in the production and development of advanced gelatin-related technologies.

Softigel by Procaps Brochure

Stability Analysis of Proteins for the Biopharmaceutical Industry

Malvern Instruments

The biggest class of biopharmaceuticals on the market is monoclonal antibodies (mAb) and their specific binding nature provides an opportunity to use them to modulate pharmaceutically-relevant molecule activity to control or prevent disease.

Stability Analysis of Proteins for the Biopharmaceutical Industry