Development of biologic therapies can present a number of unique challenges for formulation scientists and process engineers. Issues such as the stability of the biologic material in a solution state must be considered along with the overall practicality of a formulation in terms of manufacturing, storage, transport, and administration.

CDMOs in the pharmaceutical/biotech industry rely heavily on state-of-the-art instrumentation to bring their client’s products from drug development through drug manufacturing to the patient. To better serve their client’s needs as technology and the pharmaceutical industry advances, a CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation.

Active ingredients have become increasingly complex and costly to manufacture. This paper outlines strategies aseptic drug manufacturers can adopt to maximize the final yield of their products.

By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.

Explore the impacts of a fully integrated filler/isolator system with built-in decontamination technology operating principles, which combine to radically reduce and simplify manufacturing documentation. 

Batch sizes required to manufacture therapies have grown smaller since the days of blockbuster medicines, challenging smaller pharma companies to change equipment and manufacturing processes.

Inadequate communication and knowledge transfer between the originator and the CMO creates risk. This paper covers methods to reduce risks when moving from the lab to a GMP manufacturing setting.

This article addresses some of the challenges and solutions available to pharma/biotech companies and their supply chain partners to ensure critical clinical supply materials are ready when needed.

A small, research-focused biotech received positive results in the clinic for its current program. It needed urgent help getting clinical supplies to its distributor to make it in the clinic by January 2020.

Dealing with CDMOs can be a daunting task for some drug developers. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right partner.

Life sciences companies with complex warehousing and shipping requirements have a lot of questions. Here are the questions to ask to identify a logistics vendor with the right competency.

Learn how to perform various risk assessments to adequately determine the level of control required to ensure the safe transport of products throughout the pharmaceutical supply chain.

If you’re struggling to achieve legitimate value, take advantage of this 3-step process to strengthen your supply chain partnerships.

Supply chain visibility is paramount, but what criteria should be considered when evaluating monitoring devices whose data can be accessed from the provider’s software platform in real-time?

Once you have successfully encapsulated an (API), the next task is to characterize that product and understand its release kinetics, such that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.

The emulsion system created when forming microparticle can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.

When an employee performs a wide range of manufacturing tasks, both in and beyond his or her comfort zone, there is less likelihood of burnout.

Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow client access to data.

This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.