Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.
The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage. In addition, 97% of patients surveyed, who received medicine from specialty pharmacies with a visual temperature indicator included in the package, agree that they would want an indicator in all shipments and 95% agree the indicator increased their confidence in the medicines received.
PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients (HPAPI) project. Backed by 30 years’ experience of managing potent molecules, PCI Pharma Services is the logical choice when selecting an outsourcing partner.
The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
To patients and consumers, tablets are a simple and convenient dosage form. But the science behind compressing a block of particles or granules into a single tablet can be complicated. That’s where common compression studies can help. This article explains how to develop tabletability, compactibility, and compressibility profiles.
When scaling a new drug formulation from the development side of R&D into manufacturing, there is often a reality check with respect to process scaleup and performance of the formulation at production levels. Problems with capping/lamination and sticking/ picking are often first realized when a formulation is introduced to a level of compression required to supply market demand.
Gx® RTF vials powered by Ompi EZ-fill® enhance flexibility by facilitating packaging needs from clinical stage to industrialization with the common goal to minimize customer product risks and optimize total cost of ownership. Gerresheimer combines the competencies in converting glass tubes to serum/ injection vials and ready-to-fill processing for our pharma and biotech customers.
PCI’s Tredegar Site Announces Significant Expansion of Analytical Laboratories at its Center of Excellence for Contained Manufacturing
Philadelphia, USA- March 19, 2018. Global pharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce a laboratory expansion at its site in Tredegar, Wales, UK.
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In today’s ever-evolving medical business, technological changes require innovation to meet growing market demands and to bring about advances in the industry. One such development currently taking place in the field of clinical research is how e-tools are initiating a boost in the productivity of clinical trials.
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The UK’s leading production line event is celebrating
its 30th Anniversary. Taking place at the NEC, Birmingham from 25-27
September 2018, the exhibition showcases the latest processing and packaging
machinery. Attended by thousands of manufacturers of food, pharmaceuticals and
FMCG as well as contract packers and more. More info >>
