Karen Zink McCullough
As scientists, we recognize that ours is not a static discipline. We are trained to reflect on the scientific literature so that we can codify accumulated knowledge, test new hypotheses and move forward. We are innovators. In the 1970s, “But we’ve always done it this way” was a rallying call to change how we thought about pyrogen testing and work together as representatives of industry, government and academia to have the LAL test accepted as a substitute for the rabbit pyrogen test. I’m privileged, humbled and very proud to have been a part of that effort.
Casey Fowler
The pharmaceutical industry relies on innovation to develop new medical treatments, but bringing a product to market is high risk and high cost. It can take decades to develop a new medicine and cost hundreds of millions of dollars. What role will IP management play in protecting pharmaceutical companies in the future?
Yunyu (Linda) Yi, Li Zang
Monoclonal antibody (mAb) has become one of the fastest growing therapeutic modalities within the pharmaceutical industry, with an increasing number of blockbuster mAb drug products approved over recent years. Heterogeneity of therapeutic antibody products as a result of enzymatic/chemical modifications during bioprocessing and storage is well-documented. Protein characterization methods using LC-MS, including top-down, middle-down or up, and bottom-up approaches, have been widely used to study antibodies during drug discovery and development.
As the largest distributor of specialty products – and a leading partner in the commercialization of orphan drugs – AmerisourceBergen has become a leader in the health care industry. With the advances set forth by the Human Genome Project and the remarkable innovation of manufacturers, a new class of drugs are transforming the continuum of care.
Larry Wigman, Rolf Schulte Oestrich, Stefan Hildbrand, Hiroshi Iwamura, Francis Gosselin, Wolfgang Göhring, Fabian Schwarb, Jean-Philippe Crochard
According to ICH Q7, a starting material is defined as the point at which the sponsor commits to GMP manufacture of a drug substance. Drug substance processes are generally convergent and each branch of the synthesis begins with one (or more) starting materials. To protect patients from potential unknown impurities introduced prior to the GMP process, proposing very short synthetic routes with complex custom-made starting materials without an appropriate control strategy is not recommended; and, guidance is provided in ICHQ11.
Erin E. Jordan, Philip A. Searle
Since its early introduction in the 1960s, Supercritical Fluid Chromatography (SFC) has had a slow climb toward establishing itself as a valuable chromatographic separation tool in the pharmaceutical research industry. For decades, SFC was limited as a capillary chromatography technique; however its evolution into packed column chromatography in the 1980s,
Emilie Branch
Since 1975, when provisions allowing for the submission of data from foreign clinical trials were codified, the clinical trial landscape has grown increasingly global, with approximately half of all clinical trial sites outside the United States.
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, PhD, MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in December, 2016.
Jun Huang, Ph.D., David Lauri Pla
High shear wet granulation (HSWG) and fluid bed drying (FBD) are critical unit operations that impact granule and subsequent tablet properties in solid dosage manufacturing. An integrated Advanced Process Control (APC) system for multi-step process optimization, combining multiple technology components such as PAT, soft sensor, advanced analytics and control, has been implemented and validated in commercial manufacturing.
Avecia manufactures custom-synthesized oligonucleotide drug substances of which the majority are lyophilized to facilitate packing and shipping. These compounds are naturally hygroscopic and, unlike many small molecule product formulations, typically contain high percent levels of water. The water content must be accurately determined in order to perform mass balance analysis for assay. The assay content is critical for the drug product formulation calculations.
Tim Sandle, PhD
Sterility is a key quality attribute for a class of medicines required to be sterile. The consequences of non-sterility are direct patient harm. The degree of harm is dependent upon the route of administration and the types and numbers of microorganisms, as well as the health and immune state of the patient. The likely outcomes of the administration of a non-sterile product are disability or death.
Over the past 10 years, we have
seen a steady increase in the adoption of single-use technologies
(SUT) by the biopharmaceutical industry. The widespread
utilization of single-use filter cartridges and capsules paved
the way for acceptance of single-use bags and assemblies. The
speed and flexibility of deployment coupled with a reduction
in capital costs are the key drivers pushing industry adoption of
SUT. Furthermore, the advantages of pre-sterilization and reduced
risk of cross-contamination have made these technologies the
preferred choice for many applications.
Ken Wong, Jeffrey Johnson, Sally Kline, Robert Repetto, Ekta Mahajan
Single-use technologies (SUT) for biomanufacturing, otherwise known
as disposable technologies, have the potential to transform the industry
through more cost effective solutions and solve crucial manufacturing
and compliance problems. Today, suppliers have made great advances
in SUT, but the vision of better, faster and lower-cost operations has not
been fully realized. Over the past two years, the BioPhorum Operations
Group (BPOG, see box) has been painstakingly developing best
practices for SUT and work streams for extractables and leachables, user
requirements and change notifications are advancing and improving the
implementation of SUT. Collectively, these efforts represent thousands
of man-hours and pool the knowledge and real-life experiences of many
of the leading biomanufacturers embracing this technology. But much
more is on the horizon. BPOG and its member companies are developing
a five-year vision (see Figure 1) for SUT, targeting a selection of SUT and
auxiliary systems that are critical to ensure that SUT are a mature and
established technology for biomanufacturing.
What are some “must-have” features that
pharma companies are looking for when
evaluating Liquid Chromatography and Mass
Spectrometry equipment?
Davy Guillarme, Ph.D., Jean-Luc Veuthey
Reversed phase liquid chromatography (RPLC) is the gold standard
analytical strategy in the pharmaceutical industry. In this contribution,
we will describe two alternative chromatographic approaches, namely
hydrophilic interaction chromatography (HILIC) and supercritical fluid
chromatography (SFC), which are more and more commonly used in
pharmaceutical analysis. Among their advantages, these two strategies
offer better retention of polar substances, alternative selectivities and
enhanced MS sensitivity, in comparison with RPLC.
Serguei Tchessalov, Ph.D., Dawood Dassu, Dave Latshaw II, Suresh Nulu
While freeze-drying modeling is well established and documented,
the extent of its application to routine operations, including
development and manufacture, has not yet been fully realized. A
survey, conducted by the BPOG collaboration of major pharmaceutical
companies, revealed that only a few companies use modeling for
scale up and transfer. For the last year, the collaboration has been
combining individual company efforts with the aim of harmonizing
best practices and helping to define minimum regulatory standards.
This paper outlines different applications of modeling to freeze-drying
of biopharmaceutical products at commercial scale. It also signals the
intent of the BPOG collaboration to champion a wider adoption, and
realize the full potential of modeling across the industry to standardize
lyophilization practices, accelerate technology transfers and optimize
operational performance.