Pharmaceutical Manufacturing

Pharmaceutical Manufacturing
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The pharmaceutical industry is characterized by strong regulations. And if other industries give their best to guarantee their products’ quality, the pharma industry is obliged to warrant the safety of its products to the final consumer. In this context a successful equipment maintenance strategy is the most important step for a production plant to...

Pharma companies continue to face challenges of globalization, complex supply chains and hyper-competition - all while demand for treatments continues to increase. As a result, the need for greater throughput, higher quality and reduced costs has become a top priority. Over the last two decades, lean programs have become a popular approach to...

Granulation processes are used routinely across a number of industries to transform the properties of powder blends, often with the aim of producing an optimized feed for subsequent processing. High shear wet granulation (HSWG) is a flexible, efficient and reproducible technology and the preferred choice for many pharmaceutical applications....

Pharmaceutical Manufacturing

 •  December 27, 2017

Rather than simply list a bunch of equipment introductions, I am presenting a smaller number of technologies (hardware and software) applicable to PAT/QbD. The format will be mini-interviews and will touch on the highlights of each instrument/program. Since I have some (professional) personal favorites, I am going “Oprah” in this feature. 1....

Pharmaceutical Manufacturing

 •  December 26, 2017

As part of a maturing industry, pharmaceutical companies are under significant pressure to both innovate and successfully manage increasingly complex operations, more stringent regulatory requirements and frequent consolidations. Many are rethinking their quality management systems (QMS), recognizing the imperatives to enhance agility and improve...

Pharmaceutical Manufacturing

 •  December 15, 2017

The move to an electronic batch record (EBR) system has been beneficial for most pharma manufacturers. By replacing paper-based workflows with computer-based workflows, they have reduced the risk of human error and sped up compliance processes. But EBR systems can do far more than digitize paper-based workflows and recordkeeping. When integrated...

Pharmaceutical Manufacturing

 •  December 15, 2017

Keeping up to speed with the ever-changing global regulatory environment is enough to make anyone’s head spin — yet it’s vital when it comes to ensuring ongoing compliance, as well as making the right decisions for pharmaceutical organizations. The benefits of proper regulatory intelligence are vast, especially at a time where speed-to-market is...

Pharmaceutical Manufacturing

 •  December 12, 2017

Sometimes a year will go by and the regulatory process will seem to move in geologic time (versus real time) and nothing new has happened, that was NOT the case in 2017 which has shaped up to be a very a busy year for the FDA and drug developers. This article will explore all the major changes this year including guidance documents drafted and...

Pharmaceutical Manufacturing

 •  November 27, 2017

Our cover story this month details the results of BioPlan’s Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. A common concern reported from respondents (both end-users and suppliers) was capacity constraints, and how improvements in upstream processing technologies have led to downstream processing bottlenecks....

Pharmaceutical Manufacturing

 •  November 21, 2017

Monoclonal antibody (mAb)-based therapeutics are the dominant class of molecule in the biopharmaceutical market today. Year-on-year the number of approved mAb-based therapeutics continues to grow and 2017 is set to be a record year with eight approvals already granted. It is well documented that mAbs are composed of a large number of variants which...