PHARMACEUTICALS
Expert CDMOs are playing a critical role in driving the success of complex biologics , supporting biotechs with scientific expertise that is both comprehensive and diverse . Overcoming the challenges that these therapeutics present relies not only on in-depth technical knowledge but also on fostering collaboration between teams to provide a holistic understanding of the drug and production processes .
Challenges in ADC production
ADCs combine the specificity of antibodies with the potency of small molecule cytotoxic drugs , enabling targeted cancer treatment . By bringing biological and chemical components together , these therapies have been demonstrated to be more efficacious than traditional chemotherapies . Their success has subsequently led to the approval of 13 ADCs to date by the US FDA for various haematological and solid organ cancers . 4
The biopharma industry was initially slow to embrace ADCs , owing to their complexity . Challenges surrounded poorly designed linkers , limited therapeutic profiles and a lack of stable conjugation methods . Chemists have since focused on developing linker technologies to attach the drug payload to the antibody and optimising the structure of the drug payload to improve its potency and reduce its side effects .
Despite advances , developers and manufacturers still face many challenges when producing ADCs . In particular , the conjugation reactions used in ADC development and manufacturing are becoming more complex , relying on multiple steps and potentially requiring purification steps between reactions .
When seeking support for ADC production , biotechs must identify
CDMOs with the biological and chemical expertise needed to effectively manufacture cytotoxin , support conjugation and work with controlled substances . The teams involved must collaborate closely with a holistic understanding of the project to ensure that biological and chemical components work together seamlessly . By offering facilities specifically designed to handle highly potent compounds and equipped with state-of-the-art technology , expert CDMO partners can manage the complex processes involved in ADC production and ensure timely and efficient delivery to the market .
Advancing CGT therapies
The intersection of chemistry and biologics has paved the way for personalised medicine , tailoring treatments to individual patients based on their genetic makeup , disease characteristics and response to therapy . As a result , the CGT space is expanding rapidly , giving patients personalised treatments for genetic diseases .
By tailoring CGTs to the individual patient ’ s genes , these therapies can target the underlying genetic cause of the disease and provide a more effective and durable treatment option . There are currently more than 2,100 gene therapies in the development pipeline , targeting indications ranging from cancers to rare diseases and neurological disorders . 5
However , the complexity of the manufacturing process is a significant hurdle when delivering these innovative products to patients . The intricate steps of cell culture , fermentation , purification and quality control demand precise execution to ensure the safety , efficacy and consistency of the final product .
CGTs also have unique requirements throughout manufacturing , such as the need to separate full viral vector capsids . Scaling these products adds further challenges , particularly triple transfection steps , where a solid understanding of fluid dynamics is essential for increasing the likelihood of an efficient and successful transfection process .
Biotechs must therefore choose a CDMO partner with the necessary capabilities to support their CGT project as it scales from clinical to commercial and which possesses the technical expertise to overcome these unique challenges .
They must also have an in-depth understanding of biochemistry , including the molecular mechanisms underlying gene expression , cell signalling and immune responses , to develop safe and effective therapies . In particular , expertise in biochemistry is critical when engineering viral vectors to enhance targeting abilities and resistance to immune responses . 6
MAY / JUN 2024 SPECCHEMONLINE . COM
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