Elizabeth Admirand
The hurdles and costs associated with bringing a drug through the
development and approval process have skyrocketed. Over the past
forty years, the average cost of running a preclinical program has jumped
from hundreds of millions of dollars to billions of dollars. This financial
commitment is burdensome for everyone in the pharmaceutical industry
but can be crushing for a small company.
Zvonimir Majic PhD, Erik J. van Asselt, PhD, Rafik H. Bishara, Ph.D.
Global air freight industry contributes with 0.5% of global world trade in volume but raises at the same time up to 35% of its value or $6.4 trillion according to Air Transport Action Group (ATAG). Managing the transportation of temperature controlled products (refrigerated and frozen) will total $12.6 Billion in 2016 of the total of $78.8 Billion pharma logistics market.
Jeffery M. Carrico
The USP has created a new chapter to address the storage and
distribution of IDP. This is significant because it is the first time in the
long history of USP standards that this topic has been addressed. But in
order to fully understand the depth and scope of this new chapter, the
history of its inception must be covered first.
Christian Gross
Serialization has emerged as a complex challenge for the pharmaceuticals sector. The industry is currently facing a multiplicity of differing regulations governing serialization that vary from one country to another. Several countries including China, South Korea, Turkey, Argentina and Brazil already have different types of regulations in place, that must be complied with, that in turn require different types of serialization solutions for their pharmaceuticals, whilst many others, including countries in the EU and the US, face pending compliance requirements.
Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) for January-February, 2016. In these two months, FDA approved 25 NDAs.
Eric S. Langer
Around 45% of biopharmaceutical manufacturing organizations expect to off-shore at least some of their operations over the next five years, with the figure dependent on the nature of the activity, according to BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.
Haiko Pillu
When clinical trials were first developed to test the effectiveness of drugs in treating diseases, it was usual to carry out tests using multiple drug samples, including for pharmacokinetics (PK) and other assessments such as pharmacodynamics (PD). Samples were taken individually, and the time required for processing each was limited. Typical preparation techniques included centrifugation, aliquoting and freezing. Other preparative techniques would be employed when larger sample preparation flows were necessary.
Ed Price
The roles of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are growing at light speed as pharma, life sciences and biotech firms of all shapes and sizes discover the benefit of outsourcing key functions in the race to get products to commercialization faster and more efficiently. But unlike the traditional model, in which a company conducts R&D, as well as manufacturing and commercialization in-house, this new services-based model requires a new way of thinking. So what does it take to ensure a good working relationship between a sponsoring organization and the CMO/CRO?
Gil Y. Roth
The number one trend from last year’s edition demands a repeat (see - (http://pharma-bio.org/pdfs/CPhI%20annual%20report%202015.pdf - page 46). The CMO/CDMO sector remains fragmented, and business logic dictates that the sector needs to consolidate (or rationalize, if that’s your term of choice). It’s been this way for years, so if we keep calling for it, it’s bound to happen, right?
Govindra Singh
Whether producing biologic or small-molecule drugs, pharmaceutical manufacturers (sponsors and contract service organizations) must manage a complex network of raw material suppliers, which provide chemical and biological materials; including starting compounds, intermediates, solvents, cell lines, yeast, bacteria, cell-culture media and feeds, excipients, production materials such as tubing, single-use manufacturing equipment and packaging materials, among others. Ensuring that the correct materials have been received and that they meet quality and other specifications (such as manufacture under GMP conditions) can be a daunting task. Extensive collaboration with preferred suppliers and reliance on third-party vendors that can handle some of the workload are two strategies that can help simplify the issue and reduce supply chain risk.