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Biopharmaceuticals are an innovative growth industry, set to challenge the frontiers of medical therapeutics. We talk biopharma with Gustavo Mahler, CEO of AGC Biologics.

Biopharmaceuticals is an industry that manufactures biological medical products – drugs synthesised from living sources, whether plant or animal. The products may include, for example, vaccines, blood, gene or cell therapy.

Ralf Otto and co., writing for McKinsey & Company in 2014, said that “The huge, complex structures of these drugs don’t just look extraordinary in the 3-D modelling systems used to design them; they also perform their jobs remarkably well, offering high efficacy and few side effects.”

Biopharmaceuticals make up about 20% of the global pharma industry and generate revenues of $163 billion. Moreover, it’s the fastest growing part of the pharma industry because the products can command a high price that reflects the degree of innovation needed to produce them and their safety.

All this means, says Otto and co., that “Biopharma looks poised to transform the industry once more.”

Here at Business Worldwide Magazine, we want to know what makes the industry tick. So we talked to Gustavo Mahler, CEO of AGC Biologics, an innovative biopharmaceutical company with international reach, about what they do and how they’ve achieved their extraordinary success.

Can you tell us about a bit more about AGC Biologics?

AGC Biologics is a leading global contract development and manufacturing organisation (CDMO), with a strong commitment to delivering the highest standard of service to our clients and partners.

AGC Biologics brings more than 60 years of combined CDMO experience, with more than twenty years of technical success in development and cGMP manufacturing.

We currently employ more than 850 employees worldwide, and our extensive network of state-of-the-art, commercially approved facilities spans the US, Europe and Japan.

We’ve successfully manufactured more than 200 biological products, from pre-clinical studies through commercial approvals. With an eye towards continuous innovation and an adherence to stringent quality standards, we’re dedicated to working alongside our clients, helping them to improve patient lives by bringing new biopharmaceutical products to market safely and effectively.

What specific services do you provide?

AGC Biologics offers deep industry expertise and unique customised services for the development scale-up and cGMP manufacture of protein-based therapeutics – from pre-clinical to commercial production and for mammalian and microbial.

Our comprehensive service offerings include cell line development, bioprocess development, formulation, clinical and commercial manufacturing, analytical testing, quality and regulatory services, process validation, antibody drug development and conjugation, cell banking and storage and protein expression — including our proprietary CHEF1® Expression System for mammalian production and our ASPEX platform for yeast manufacturing.

What makes your company unique?

I’d argue AGC Biologics is unique in several ways. Here are just a few.

We focus specifically on excellence in biologics development and manufacturing and are therefore continuously making strides and deepening our knowledge, expertise and innovative leadership within this dynamic industry.

Our experienced and dedicated team is focused on working side-by-side with our clients and partners to develop customised solutions and overcome complex challenges to enable project success and accelerate time to market.

We have the distinct capability to leverage the tools and resources associated with our expanding business while remaining responsive, agile and flexible to address our clients’ unique needs, requirements and timelines.

As a global leader in mammalian manufacturing, we bring industry-leading expertise in orphan drugs and mid-size products, with experience working with most expression systems on the market, as well as considerable experience with mAbs, complex proteins, coagulation factors, fusion proteins and more.

Finally, with a strong focus on integrated processes and technologies throughout our expanding organisation, we’re able to collaborate seamlessly and transition projects across our sites in the United States, Europe and Asia. This structure allows us to strategically place our clients’ projects in the locations best suited for their individual needs, with the readily available capability to quickly scale-up and transition to another site as appropriate.

What noteworthy innovations have you achieved in recent years?

At AGC Biologics, we are proud to have introduced several innovations in the Biologics CDMO space:

  • One of the first CDMOs to offer single-use technology in our manufacturing operations, both in the US and Europe
  • The first CDMO to introduce a 6-Packtm single-use manufacturing model that enables our clients to grow their manufacturing capacity as their demand grows
  • One of the first documented extensive uses of High-Throughput Technology to perform the process characterisation of a product, saving our clients time to market and cost of development
  • One of the first CDMOs receiving a breakthrough designation approval for a Biologic product

All these achievements are a testament to the innovative spirit of the AGC Biologics team. Our new R&D operations in our global headquarters will enable us to continue innovating our field.

How do you ensure that all of your products and services meet the high standards you set for yourselves?

We operate in a highly regulated industry regulated by US, European and Japanese agencies. The standards set by the authorities to manufacture biopharmaceutical products are one of the highest of our industry.

Additionally, we reinforce in each one of our employees a simple mantra: people like you and your family use the products we manufacture. You are responsible for the quality, safety and effectiveness of those products.

It takes a team with the right knowledge, dedication and personal ownership to deliver the quality products patients deserve.

You are President and CEO of AGC Biologics. What are the values which guide you in your role?

In my role, I’m guided by many values.

I’ve got a genuine passion for science and biomanufacturing. It is a fantastic time to be a part of this rapidly growing and innovating global industry.

We’re fortunate to be part of an industry that can have such a profound impact on patient lives. I do my best to inspire my team to remember this point and understand and adopt a similar passion for what we do here every day.

I’m interested in the pursuit of excellence. I continuously strive to seek new ways to improve our operations, services, innovations, collaborations and capabilities.

I believe in the value of success, first and foremost for our clients and partners.

Finally, I fundamentally believe we have a responsibility to our surrounding community. We should always remember that we cannot flourish without the support of our communities, and a mutually-beneficial relationship is the key to success.

And leading a company goes beyond revenues, profitability and growth. It involves social responsibility to both the community and the environment. AGC Biologics employees are encouraged to support local schools and charities, and we are working together with educators in our area to provide entry-level job opportunities for young people in our community.

We have a similar commitment to the environment. We are ISO 14,000 certified and have implemented several recycling and energy efficiency programs to minimise our environmental footprint.

What are your plans for 2018 and beyond?

In mid-July 2018 we inaugurated a new facility in Bothell, Washington as our Global Headquarters. This expansion provides us with the additional footprint to significantly increase our manufacturing capacity within the United States.

Also, we’ll be implementing a new, state-of-the-art R&D centre at our new site, dedicated to novel manufacturing technologies for the faster development of therapeutic proteins. We plan to continue this trajectory of sustained growth and innovation on a global scale as we invest in new opportunities for further expansion, novel scientific applications, uniquely customised services and new collaborations and partnerships.

We also are expanding our capacity by adding an additional 6-Packtm facility in Copenhagen, Denmark and building new labs in our operation in Heidelberg, Germany.

The future for biopharmaceuticals is full of promise, and we always have and will continue to deliver high-quality products to help improve patient lives around the world.