From biologics to delivering in the COVID-19 pandemic, adaptable CDMOs are helping overcome many of biopharma's biggest challenges—a view from Syngene

*Partnered content

The questions that were posed to the biopharmaceutical industry in 2020 were more urgent than ever before, as the COVID-19 pandemic brought much of the world to a standstill.

But the industry delivered with aplomb, developing vaccines and therapeutics that have allowed many people to return to healthy, productive and vibrant lives.

What is even more incredible about this achievement is that much of the science underpinning the new vaccines, in particular, has been based on mRNA technology, a new approach that was never used in patients until now.

The scale of this challenge has made the manufacturing behind the vaccines crucial, and brought into action an ecosystem beyond the pharma companies themselves.

Syngene International (NSE: SYNGENE), an integrated research, development and manufacturing organization, is well-placed to understand the demands surrounding raw materials, technology and complex manufacturing processes, and the crucial role that contract manufacturing organizations (CMOs)/contract development and manufacturing organizations (CDMOs) play when meeting huge demands rapidly and safely.

Syngene is an innovation-led CDMO offering integrated scientific services from early discovery to commercial supply.

- How can people get in touch/find out more?  Email or with the ‘Get in Touch’ form via  this link

The challenges that come with producing vaccines for a scenario like the COVID-19 pandemic, drugmakers’ use of conventional manufacturing facilities —coupled with the cost of setting up new capacities capable of producing millions of doses—are among the reasons that using CMOs/CDMOs provide risk mitigation, according to Syngene’s chief operating officer, Mahesh Bhalgat.

Such companies can ease capacity constraints, and help in responding more quickly to changes in demand. Whether the technology involved is reliant on r-proteins, viral vectors, or mRNA, many CDMOs already have the expertise/capacity in this area to produce first-generation vaccines, at speed.

The flexible facilities with single-use disposables for manufacturing that are used by most CMOs/CDMOs also have advantages over reusable systems used by traditional biopharma companies, leading to cost savings and faster time to market.

Experience of embracing the biologics revolution

Long before the pandemic, Syngene was evolving to keep pace with the changing challenges landscape and technologies in the biopharma sector, including the arrival of large molecules, or biologics.

Dr Bhalgat told The Pharma Letter of the type of difficulties that drugmakers can face in this field. Biologics, or biopharmaceuticals, are large protein/peptide/nucleotide (DNA/ RNA) molecules that have a complex production process and are often challenging products to develop and manufacture.

Additionally, given the success of biologics in various medical indications, there is a constant drive to develop successful drugs while reducing costs to keep biologics affordable, Dr Bhalgat explained.

Cycle times in drug development are longer than small molecules.

“Process time is longer—from 10 to 60 days,” Dr Bhalgat said. “Molecules are prone to undergo multiple complex changes during manufacture mechanisms such as post-translational modifications.

“There is a need for rigorous process control strategies. Some unit operations may not be linearly scalable.”

How Syngene can help

Syngene’s understanding of the challenges is important, but even more so are the solutions it offers.

“We have a well-developed single integrated platform that is available to everyone, thus leading to reduced timelines and costs,” Dr Bhalgat said. “We apply technologies that lead to robust scalable processes, reducing the time to reach the market.”

Syngene is able to cut cycle times with application of high throughput technologies that reduce time-consuming activities. The company’s use of the aforementioned single-use technology—disposable bioreactors—ensures sterility, no risk of contamination and fast changeovers.

For all class of modalities, the company has built up significant in-house expertise and can offer end-to-end services. The establishment of a platform for accelerated time to market has shortened the time from gene to GMP to nine months.

Dr Bhalgat said: “Syngene’s development and manufacturing facility has been designed to handle multiple projects simultaneously; we have built up state-of-the-art analytical capabilities towards characterization and understanding of molecules; our facilities are designed to US Food and Drug Administration and European Medicines Agency standards; design is focused on engineering controls for robust compliance; we have established scale down models up to 50-times scale up.”

Years of experience working with the world’s top biopharma companies

Syngene’s track record as a quality-driven organization is proven by a host of international awards, recognitions and accreditations to prove the safety and efficiency of its facilities and systems.

But Dr Bhalgat also believes that the company’s flexibility, early decisions to enter into biologics and openness to new ideas set it apart from other CDMOs. Developing the ability to manufacture mRNA has just been one example of this.

“We have worked on several complex molecules ranging from growth hormones, monoclonal antibodies, bispecifics, single chain variable fragments, conjugated proteins to whole microbiomes,” he said. “We offer a one-stop solution from sequence to GMP manufacturing, with all required testing and analysis. We have many years of experience in working with the world’s top biopharma companies who work with us not just for operational execution but also for product strategy.”

Options for flexible business models

Adaptability and flexibility are truly two of Syngene’s most differentiating prominent features, building on inherent strengths of scientific prowess and expertise.

“We provide options for flexible business models,” Dr Bhalgat said. “We cater for a wide variety of requirements, starting from stand-alone small projects, integrated projects to dedicated centers.“In the biologics space, Syngene offers services from lead identification to clone development, to GMP cell banking to process development and scale-up to commercial manufacturing of drug substance and drug product. Syngene also provides unique services for a one-stop experience suchas viral testing and virus clearance services as well as dedicated stability centers.”