Authors


Nicholas Simmons-Stern

Latest:

Innovative Contracting Solutions in a Changing Healthcare Landscape

Pharmaceutical and biopharmaceutical manufacturers must start thinking about new ways to navigate the evolving healthcare marketplace while continuing to deliver life-changing therapies to patients and responding to the demands of an increasingly informed and sophisticated customer base.


C. Vervaet

Latest:

Understanding Fluidized-Bed Granulation

This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.


Anthony Prior

Latest:

How to Give Pharma’s Culture a Collaborative Shot in the Arm

Everyone talks about “open innovation,” but without the right working culture it won’t succeed. MeetingZone’s Anthony Prior explains how unified communications can help kick-start the necessary change.


Sangita Ghosh

Latest:

Addressing Segregation of a Low-Dosage Direct Blend

The authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.


Palak Shah

Latest:

Identifying Causes Of Delamination

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.


Carol Rea Flynn

Latest:

Identifying Causes Of Delamination

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.


Dan McNerney

Latest:

Identifying Causes Of Delamination

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.


Robert Harris

Latest:

Outsourcing Formulation Development for High-Potency Compounds

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.


Elaine Gray

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


David Keire

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Barbara Mulloy

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Ali Al-Hakim

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Christina Chase

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Monica Da Luz Carvalho Soares

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Damian Cairatti

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


John Hogwood

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Paulo Mourão

Latest:

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.


Krasimir Vasilev

Latest:

Controlled Release from Porous Platforms

The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.


Gordon Haines

Latest:

Why Training Matters

Investing in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.


Marcus Spreen

Latest:

Why Training Matters

Investing in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.


T. De Beer

Latest:

Understanding Fluidized-Bed Granulation

This study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.



Bob Serfas

Latest:

Best Practices for Color Coding

Pharmaceutical manufacturing facilities can help prevent contamination and cross contamination by using color coding.


Ambuj Jain

Latest:

Emerging Markets—An Opportunity for Pharma to Drive Sustainable Growth

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.



Bob McDowall

Latest:

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.


Patricia Santos-Serrao

Latest:

Reducing the Documentation Burden in Process Validation

The author discusses the collection and evaluation of data part of FDA’s definition of process validation.



Courtney M. Callis

Latest:

EMA Guideline on Setting Health-Based Exposure Limits

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.


Bruce D. Naumann

Latest:

EMA Guideline on Setting Health-Based Exposure Limits

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.