By CERBIOS-PHARMA SA
Denis Angioletti (Cerbios CCO) contribution to Chemistry Today panel on HPAPIs
Lugano, Switzerland: – Leading pharmaceutical CDMO Cerbios-Pharma SA (Cerbios) has a long standing experience in the development and commercial production of highly potent active ingredients (HPAIs).
Cerbios-Pharma Chief Commercial Officer Denis Angioletti, participating in a panel discussion of the HPAPI sector organised by the online magazine Chimica Oggi (Chemistry Today), said CDMOs needs to keep the focus on innovation and safety to meet the challenges that new HPAPIs bring with them.
HPAPI market overview
The panel was convened to consider how the synthesis of small and large molecules (peptides and antibodies) has required the development of new technologies in chemical synthesis, along with purification and isolation steps. These breakthroughs have created a new class of highly active and therefore high toxicity High Potency Active Pharmaceutical Ingredients (HPAPIs).
In simplest terms, there has been a shift in emphasis from protection of the molecule from cross contamination or deviation from process to prioritization of protection of the environment and workers from contamination by the molecule.
The Chemistry Today panels, representing senior professionals from 15 development and manufacturing organisations were asked to assess current HPAPI market trends, challenges, regional variations and their own company’s responses.
Ever greater specificity and potency
In his responses, Denis Angioletti began by acknowledging the clinical need to boost the efficacy of the molecules and make them more site specific while reducing their side effects.
He said this had led to the development of more targeted molecules, drug designed to increase their specificity as well as get the necessary stability in the body, specifically at their actual site of actions.
“From a manufacturer perspective, this leads to the need to have in place different complex technologies and be prepared to use them for HPAPIs,” said Mr. Angioletti.
“It also means it is not just about making HPAPI, it is more and more about which technology for which class of HPAPI. It is not just a matter of potency but a matter of having complex and specific technologies applied and installed to manage HPAPIs,” he explained.
HPAPI manufacturing challenges
“You must have the right risk management and containment strategy when using complex equipment and technologies. For this reason you need to know how to design your plants and install equipment accordingly. In parallel, it is of essence having the necessary know-how for all your technical team, from R&D to engineering and production, ensuring for anyone a continuous training,” Mr. Angioletti declared.
For Cerbios this had required not only increasing its HPAPI manufacturing capacity but also making it more sophisticated and regulation compliant.
“In 2021 we completed and got SwissMedic approval for a new HPAPI unit which allows us to manufacture batches up to 30 Kg/batch improving our range of capacity from very small scale up to these 30Kg/batch with different lines for cytotoxic and non-cytotoxic units,” Denis Angioletti reported.
HPAPI facility investments
He said Cerbios was additionally advanced in the construction of a new building, due to enter service in early 2023, which will have two complete HPAPI manufacturing lines primarily dedicated to Antibody Drug Conjugate (ADC) payloads and cytotoxic APIs.
“Next to these manufacturing units, we have recently opened new R&D units which increase by 50 percent our R&D capabilities for HPAPIs chemical development and double the capacity for R&D analytical services for biotech and chemical products,” said Mr. Angioletti.
“All these investments allow us to guarantee to our clients much more flexibility and speed to execution as well as completing our offer with an expanded range of technologies and scale of manufacturing,” he observed.
Ideal HPAPI partner attributes
Mr. Angioletti said the ideal CDMO partner for a HPAI should be capable of developing a process from the earliest discovery stages.
“As we all know, discovery and innovation come frequently from start-ups and small companies that need to move fast from discovery to the first in human. These companies need a partner who can develop the manufacturing process of their small molecule or biotech discovery to a process robust enough to be scaled to cGMP production,” he explained.
“Additionally, a CDMO partner has to be a specialist and must have done, be doing, and be ready to do, the necessary investments for the necessary technology, due to the increased complexity of the molecules,” he added.
“A CDMO needs to have the necessary know-how to handle such technologies or, primarily, to be prepared to engineer and install new technologies in its plants, as particular molecules demand. This is a continuous work in process, with more and more particular technologies becoming absolutely necessary,” said Mr. Angioletti.
Cerbios is a privately held company located in Lugano, Switzerland, specialized in manufacturing Pharma Products and in offering CDMO services.
Cerbios is the ideal CDMO partner from clinical to commercial supply of API, HPAPIs, Payloads, ADCs, Proteins and Antibodies. Services offered include Process & Analytical Development, Scale-up and Clinical Supply, Industrial Validation, Commercial Supply, Full CMC Regulatory Support. Proveo™, a division of Cerbios, was recently created to provide end-to-end development and manufacturing services for ADCs.
Cerbios is also a global leading supplier of a portfolio of Generic APIs primarily used in Oncology and for the treatment of Respiratory and Dermatological disorders. Cerbios has additionally a 40 years’ experience in the probiotics field: the portfolio includes a FDF based on proprietary strain SF68® for treatment of diarrhea and dysbiosis by antibiotics and two new Food Supplements for the management of ACNE & Seborrheic dermatitis and to boost immune response.
Learn more at: https://cerbios.swiss
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