Facilities Featured Articles

  1. The Importance Of Solid Fraction Data In Roller Compaction Operations

    Roller compaction is a continuous dry granulation process to increase the bulk density and uniformity of powders into free flowing granules used in downstream manufacturing operations. It is a complex procedure due to the diversity of available powder blends and the control and adjustment parameters involved in the process. In pharmaceutical operations, the Roller Compaction process has significant effect on particle size distribution, porosity, flowability in downstream operations, homogeneity, compactability and compressibility of the API, additives/ excipients. These factors influence dissolution profiles, disintegration time, and hardness of the produced solid dosage form.

  2. Perfect Potent API Processing: Handling Hazardous Drug Actives Effectively

    The journey from discovery laboratory to pharmacy shelf is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage of the journey.

  3. 3 Development Principles Of Advanced Biopharmaceutical Tubing

    Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. Advancements associated with tubing may not necessarily be perceived as revolutionary, but there is an ability to innovate in this space. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the three development principles in this article should take place.

  4. 5 ADC Manufacturing Challenges You Need To Know

    The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.

  5. How To Boost Profits With Single-Use Powder Transfer In Biopharma

    Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?

  6. Increase The Speed To Clinic Of New Biopharmaceuticals With This Approach

    The biopharmaceutical market has enjoyed a significant expansion over the past few years. By Hugo DeWitt, Mitch Scanlan, Tim Ward and Christel Fenge

  7. Methods Of Containment For Solid Dose Blending And Manufacturing

    Two methods of containing blenders have been demonstrated. Included here are the use of flexible enclosures and separate, disposable powder transfer systems.

  8. New Possibilities In Laboratory Automation With Ready-To-Install Subsystems

    Analytical laboratories have to provide sound results in a short time. Speed and reproducibility play a significant role here. Modern automation technology saves time, increases quality and reduces costs for the transport and distribution of samples. By Paul Kendall

  9. Automating Technology In The Production Of Infusion And Blood Bags

    The trend in automation technology is towards smaller, multifunctional components. Compact one-way flow control valves type VFOF-LE-BAH are one of the latest developments in the field of pneumatics. By Peter Kronawitter

  10. A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017

    The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.