Newsletter | May 2, 2021

05.02.21 -- Anticipating Issues And Solving Challenges In Biologics Therapy Development

Systematic Approach To Early Phase Sterile Drug Product Technology Transfer

How should a manufacturer prepare for the initial transfer of a lab-scale process to the manufacturing plant? The more systematic the production approach and the more coordinated the effort between formulation scientists and manufacturing personnel, the more likely it is that the transfer will be successful.

Maximizing Batch Yields In Aseptic Manufacturing: High-Value Actives

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.

Overcome The Challenges Of Biologics Finished Product Manufacturing

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.

Case Study: Truly "Focused On Faster" For Aseptic Filling

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.