INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Are Oral Dose Manufacturing Projects Becoming More Complicated?

  Has the complexity of oral dose manufacturing projects changed in recent years? Are CDMOs evaluated on the same metrics for simple and complex oral dose manufacturing projects? Data from ISR’s new report provides insight on these questions and more.

• Choosing The Right CDMO For HPAPI Development, Manufacturing & Packaging

  Pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging, and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Experts discussed the key considerations and best practices when outsourcing HPAPI development, manufacturing and packaging to a CDMO.

• Multidrug Combo For Companion Animals

  A leading multi-national animal healthcare client was working on a novel three-drug combination product for the treatment of seasonal ticks in companion animals. The client wanted to stabilize a low dose drug that is highly prone to hydrolytic degradation and also ensure content uniformity of the active within the microgram dosage.

• The Shift Toward US Pharmaceutical Manufacturing

  The pandemic has brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and re-igniting discussions around the value of reshoring production. Explore effective strategies to secure and de-risk pharmaceutical supply chains.

• Orphan Drug Development – A Pragmatic Approach To Developing A Rare Disease Drug

  9/1/2021

  We are beginning to see a rise in the interest of developing "orphan drugs," or pharmaceutical agents intended to treat rare diseases. Discover challenges and considerations associated with the expedited development of orphan drugs and how to successfully work through them.

• Commercial Manufacturing In Half The Time

  9/1/2021

  Due to US FDA requirements for commercial manufacturing of regulated (GMP) intermediates, a global pharma company quickly needed a dedicated production facility to produce its commercial antibiotic (carbapenem) intermediate.

• We Are Asymchem

  8/30/2021

  We're a CDMO that researches the possibilities, develops new technologies, and applies new processes in a continual drive toward optimization.

• Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Product Development

  8/16/2021

  A key tool to address tight timelines and complex molecules is precision powder micro-dosing in capsules, which makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited API, while avoiding premature termination of otherwise promising APIs.

• Benefits Of RABS And Isolator Technology In A Changing Regulatory Landscape

  8/10/2021

  Restricted Access Barrier System (RABS) or isolator technologies represent an integral component of a manufacturer’s quality control strategy. The current regulatory landscape requires drug manufacturers to employ a RABS or isolator as part of their risk mitigation approach, and companies looking to develop in-house capabilities or contract to a CDMO should understand the key elements of each in order to make the best, most informed decision for their product.