Solid Dose Realities
While biopharma's parenterals may be the belle of the ball lately, solid dose's dance card remains booked; the dosage form of choice for billions of patients. Far from the dowdy, aging wall flower one might expect from such a mature segment , but the reality is some of the most exciting technological advancements in Pharma processing are occurring right now as Branded, Generic and CMO players push for more speed, more capacity and quality in solid dose cGMP operations. Editor Steven Kuehn takes a close look at the realities at work, highlighting innovations and best practices along the solid dose manufacturing continuum.
Critical Success Factors in Raw Material Storage and Conveyance
According to Mark Hoffman, PE, SSOE Group, a well-designed, reliable raw material storage and conveyance environment can make or break a pharmaceutical manufacturing environment. Raw material storage and conveyance is fundamental to quality assurance and profitability. Increasingly, this environment also has become integral to the rigorous regulatory requirements for tracking and tracing products throughout the supply chain. Hoffman explores ways to meet quality and standardization objectives and pursue design solutions based on an overview of the entire process from delivery of raw materials to the manufacturing site to delivery of product ingredients to the manufacturing line.
Proactive Quality & Compliance
High Potency Product Manufacturing
Approximately 25% of drugs in development worldwide are classified as highly potent, and according to Alkermes' Senior Director Fidelma Callanan, this percentage is expected to grow over the coming years. While such highly potent compounds can have significant benefits in the treatment of certain medical conditions, they present substantial challenges to the pharmaceutical industry. Callanan outlines elements that should be considered by any drug Sponsor/Donor when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
Integrated Continuous Manufacturing of Pharmaceuticals
Pharmaceutical manufacturing has been performed using batch technologies for over a century. This practice, say Salvatore Mascia and Bernhardt Trout of CONTINUUS Pharmaceuticals (a spin-off of the Novartis-MIT Center for Continuous Manufacturing), results in very long and expensive processes that have been supported by high gross margins. In contrast, the development of novel manufacturing technologies has the potential to transform the current batch manufacturing process into a novel integrated continuous manufacturing process. Initially validated by the Novartis-MIT Center, the team there designed and constructed a small-scale prototype system to demonstrate that pharmaceuticals can be produced continuously in a fully integrated manner with automated control. Mascia and Trout take a deep dive into the approach, which opens a new manufacturing paradigm for the pharmaceutical industry.
Supply Chain Excellence
Four Pivotal Steps in Early Stage MDI Formulation
Pressurized Metered Dose Inhalers (pMDIs) are complex systems and technically challenging to develop. According to Alex Slowey, a formulation specialist, 3M Drug Delivery Systems, in order to successfully formulate a pMDI system, there are many factors that need to be assessed and brought together. In his article, Slowey recommends a total system approach to fully design and optimize the production order for it to meet the stated design requirements.
Automation and Control
Siemens and Rutgers Team Up for Continuous Innovation
Rutgers University is at the forefront of the continuous manufacturing research and development. Early on, Siemens formed a relationship with Rutgers to help push the envelope and modernize pharmaceutical manufacturing and dosage forms for a more efficient future. The foundation of this relationship is built on Siemens becoming a member of the Center for Structured Organic Particulate Systems, more simply known as C-SOPS. Here Siemens recounts how C-SOPS' has made great use of Siemens SIPAT technology in support of continuous manufacturing's operational excellence.
Product round-up from prominent equipment suppliers.
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