Flexible production scheduling from a CDMO helps sponsors control costs and timelines even when unexpected development delays occur.

Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.

To serve client needs as pharma tech advances, a CDMO must know when to acquire new tech, increase overall instrument capacity, and maintain existing validated instrumentation.

Advances in drug and biologics discovery have allowed the development of more sophisticated and highly targeted therapeutics, with active ingredients becoming increasingly costly to manufacture. Handling high-value, complex active ingredients requires a mindset that rigorously protects against unnecessary loss of active ingredient.

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.

As pharmaceutical companies develop therapies targeting rare diseases, more small batch projects are emerging, along with an increase in outsourcing projects with short lead times for aseptic filling. This case study presents a small, research-focused biotech company that quickly needed their finished drug product clinical supplies delivered to their distributor.

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.

The main challenges associated with scale-up and manufacture of the first clinical supplies of an aseptic drug product fall into one of three categories: formulation, fill/finish, or post-production. Explore these areas to find considerations and explanations surrounding the development of biologics therapies.

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.