Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.
The pandemic and shifting focus to more complex therapeutics are driving growth in the outsourced formulation development services market.
A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.
Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.
Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.
Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
As the therapeutic landscape grows more complex, so too must the analytical techniques for cleaning validation to ensure the utmost cleanliness is achieved.
Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.
Alternative approaches to freeze drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.