White Papers

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

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

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

Validated Metal Analysis

Pfanstiehl

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

Validated Metal Analysis

Critical Containment Products for the Pharmaceutical Industry

PBSC

Due to its relationship with US-based Presray, PBSC has been able to expand its product range for the laboratory and cleanroom settings and the two company's product ranges complement each other.

Critical Containment Products for the Pharmaceutical Industry

Micrometirics Product Brochure

Micromeritics

The physisorption line is designed to measure surface area and porosity for a wide range of materials, determining the quality and utility.

Micrometirics Product Brochure

Pharmaceutical Consulting and Generic Drug Professionals

Pharmaceutical Development Group

On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products'.

Pharmaceutical Consulting and Generic Drug Professionals

Paediatric Clinical Trials 2016

SMI

Paediatric Clinical Trials 2016 - enhancing your paediatric strategy in line to maximise clinical benefits for patients.

Paediatric Clinical Trials 2016

Bioneer Biomarker Services

Bioneer

The attached white paper is a presentation from Bioneer, which provides more information about the company and the services it provides, including immune bioactivity human DCs, biomarkers and molecular histology.

Bioneer Biomarker Services

Measurement of Pharmaceutical Lubricants Using the TriStar II Krypton Option

Micromeritics

A major advantage of using the TriStar II with the krypton option is the ability to measure low surface areas.

Measurement of Pharmaceutical Lubricants Using the TriStar II Krypton Option

Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design

Pharmaceutical Development Group

Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.

Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design

Medical Device Consultant on 510(k) Submissions

Pharmaceutical Development Group

As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.

Medical Device Consultant on 510(k) Submissions

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

Innovator or Generic, All Roads Lead to the 505(b)(2)

Pharmaceutical Development Group

Faced with decreasing R&D output, billions of dollars in patent expirations and increasing generic competition, innovators are forced to re-evaluate traditional business models.

Innovator or Generic, All Roads Lead to the 505(b)(2)

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

Discover New Opportunities For Your API

LTS Lohmann Therapie Systeme

LTS is the market leader in transdermal patches and oral thin films.

Discover New Opportunities For Your API

Kemwell: Keeping You Competitive

Kemwell

Kemwell is a 100% customer oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products.

Kemwell: Keeping You Competitive

Emerging Biotech Investment: Strategic Analysis of Private Equity and Venture Capital Funding

GlobalData

An excerpt from GlobalData's latest PharmaSphere report, this whitepaper provides in-depth analysis of the current trends and factors shaping the private equity (PE) and venture capital (VC) segments of the financial industry.

Emerging Biotech Investment: Strategic Analysis of Private Equity and Venture Capital Funding

Scientific Pharmaceutical Compounding Using Hot Melt Extrusion

STEER

Pharmaceutical Compounding using hot melt extrusion (HME) involves achieving a homogenous solid dispersion or solution by mixing and/or melting API with one or more excipients such as polymers, lipids, surfactants, diluents, lubricants, glidants, pla...

Scientific Pharmaceutical Compounding Using Hot Melt Extrusion

Use of the Fios Genomics Analysis Approach for Determining Immunity Pathways

Fios Genomics

This study determined which immunological pathways are responsible for clearance of parasitic infections in people affected by river blindness.

Use of the Fios Genomics Analysis Approach for Determining Immunity Pathways

Melusine Venom Libraries: Designed to Discover Tomorrow's Drugs

Bachem

Melusine Venom Libraries are high-quality venoms prepared and pre-fractionated on an automated platform and dispensed in micro-plates ready for high throughput screening (HTS) in targeted lead discovery projects.

Melusine Venom Libraries: Designed to Discover Tomorrow's Drugs