Personalized insights

Highlights from our discussion with Akhil Ravi, CEO of Aurigene Pharmaceutical Services.

Adaptation

Aurigene, a fully owned subsidiary of Dr Reddy’s, was formed by integrating the company’s discovery and CDMO arms in 2020.

“Attending DCAT Week 2022 is actually the first time we are attending an event physically since our formation,” says Akhil. “And it feels special even more for that reason. The challenges posed by the pandemic continue but, as a community, we have learned to adapt.”

Like other segments, the pharmaceutical industry is transforming, partially due to the pandemic, but digitization and automation leveraging artificial intelligence and machine learning are also transforming pharmaceutical research, development, and manufacturing. Artificial intelligence and machine learning will enable us to augment our discovery and process development.

Accelerating oligonucleotides

In 2018, just seven oligonucleotide therapies had received marketing authorization in the USA and/or Europe; by 2021, this number had more than doubled to sixteen. Increasing demand for oligonucleotide drugs is based on the fact that they allow for personalized approaches, as they selectively target genes with minimal side effects. For the same reason, it is possible to target patient specific sequences that are causes of rare diseases.

“Aurigene Pharmaceutical Services envisioned a breakthrough growth in this area,” explains Akhil. “This is why we proactively invested in a discovery scale oligonucleotides facility to support integrated discovery services.”

The company is continuously improving its oligonucleotide analytical capability with technology and experience, using technologies such as deconvoluted Mass Spectra to maintain accuracy in the chemical synthesis of oligonucleotides. Controlling crude purity, purification and meeting specs – especially bioburden and handling – are major challenges up up-scaling, but these can be addressed by developing robust processes, controlling the input specifications, and appropriate environmental controls.

Advancing RNA-based therapies

RNA-based therapeutics have been described as having a “limitless future” – certainly, they have created a new paradigm in global health. Success stories are already emerging in cancer care using neo-antigen-based approaches, and rapid strides made in machine learning and artificial intelligence will be a booster to mRNA-based personalised medicines. Moreover, mRNA can be a potential game-changer even for monoclonal and other antibody-based therapeutic modalities.

“The success of the COVID vaccine is only the tip of the iceberg,” says Akhil. “The true potential of this new class of therapeutics is poised to be unleashed in personalized medicine, which will likely be its most significant impact. At Aurigene, we have the capabilities to work with our partners to discover new mRNA-based therapies.”

Faster expectations

The mRNA COVID vaccines were produced remarkably quickly, and there is no doubt that they set new standards for the speed at which mRNA therapeutics can be designed and developed. It has also triggered new expectations in health care and, as more funding and investment pumps in, further advancements in mRNA delivery technologies, analytical and quality control platforms are likely.

Aurigene Pharmaceutical Services Limited (APSL) is a 700+ organization and is an integrated partner for global pharma companies. It covers the entire value chain for new therapeutics, from drug discovery, clinical research, and development to manufacturing APIs and formulation at commercial scales. It has development laboratories from discovery to clinical phase III for New Chemical and Biological Entities (NCEs/NBEs) and cGMP manufacturing facilities in the UK, Mexico, USA, and India. The technology platforms include: cytotoxic APIs, carbohydrates, steroids, PEG derivatives, prostaglandins, peptides, and oligonucleotides. Large molecule discovery services include ADC, MAB, MRNA, CART-T  as well as development services in MAB and protein therapeutics.

DCAT Week is the premier global event held annually in New York City for companies engaged in the Bio/Pharmaceutical manufacturing value chain. It is hosted by the Drug, Chemical & Associated Technologies Association (DCAT), a not-for-profit, corporate member-supported, and volunteer-led global business development association for companies engaged in the Bio/Pharmaceutical manufacturing value chain. Learn more at www.dcat.org.