Newsletter | March 24, 2020

03.24.20 -- Are You Protecting Your Product And People During ADC And HPAPI Manufacturing?

 
Are You Protecting Your Employees During HPAPI Manufacturing?
 

As biomanufacturers venture into the rapidly growing market of HPAPIs (highly potent active pharmaceutical ingredients), it is important to consider whether they have the resources and capabilities to protect their product and their employees.

Development Of A GMP Strategy For ADC Synthesis
 

Learn how the establishment and application of a good manufacturing practice (GMP) strategy can produce site-specific antibody-drug conjugates (ADCs) through the implementation of AJICAP technology, a chemical conjugation platform that employs IgG Fc-affinity peptides.

Continuous Flow Manufacturing Of Pharmaceutical Ingredients
 

Strong growth is anticipated for continuous flow manufacturing of active pharmaceutical ingredients (APIs) as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

Evolution Of AJICAP Technology
 
AJICAP technology is a novel platform for the site-selective conjugation of antibodies using a class of Fc-affinity compounds to install payload-compatible linkers to well-defined amino acid residue(s). This poster series illustrates the AJICAP technology story.
ADC Development And Manufacturing Capabilities With AJICAP Technology
 

Further understand the capabilities of AJICAP technology, including the cGMP process for the production of materials suitable for use in early development and GLP preclinical studies, obtaining a “homogenous DAR” ADC (antibody-drug conjugate), and comparative analytical methods for drug-antibody ratio (DAR) determination to apply to site-specific ADCs.

5 ADC Manufacturing Challenges You Need To Know
 

Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.

Solutions
Simplified ADC Supply Chain
 

Ajinomoto Bio-Pharma Services is a provider for high containment ADC (antibody-drug conjugate) manufacturing as well as fill and finish services for both HPAPIs (highly potent active pharmaceutical ingredients) and ADCs. Capabilities include process development, analytical development, formulation, clinical and commercial manufacturing for bio-conjugation, and fill/finish along with all supporting services for release and stability testing.