10.19.21 -- Align Your CMC Strategy With Clinical Path Requirements And Timeline

Manufacturers must understand the challenges associated with creating a CMC strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.

Surrozen’s President & CEO, Craig Parker, discusses how the expertise, resources and flexibility of Lonza have been fundamental in advancing its novel and complex bispecific antibody candidates that target the WNT pathway.

This collection of articles documents each step in the vaccine development journey and how technology and partnerships make the difference in getting medicines to patients when they need them most.

Despite the potential of ADCs and other bioconjugates, they present a wide range of challenges for drug manufacturers trying to navigate their way to commercial success.

In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

Standard techniques often involve multiple purification steps, each associated with significant product losses, therefore requiring large amounts of starting DNA to guarantee sufficient vector and insert material to complete subsequent ligation and transformation steps. In this paper, we describe the use of these ultrafiltration devices in various steps of the cloning workflow that can provide a more streamlined process and compare them against traditional methods of subcloning PCR-generated fragments.

Centrifugation and filtration have been widely accepted as techniques required for clarifying complex cell cultures to recover extracellular proteins such as monoclonal antibodies (mABs). Read an alternative to the use of centrifugation/filtration/flocculation to clarify mammalian cells cultures and describes assessment of newly developed AcroPrep 24-well clarification and sterilization plate and AcroPrep 24-well sterilization plate for clarification of mammalian cell cultures (2 to 26 x 10⁶ cells/mL) and recovery of proteins present in the supernatant.

This infographic provides facts and figures regarding the global cell line development service market, approved biopharmaceutical active ingredients and the cost of GMP certification.