Issue:October 2015

EXECUTIVE INTERVIEW – ALTHEA: Giving Biopharmaceutical Companies the Power To Make

The biopharmaceutical industry has the power to make a difference, by creating new therapeutics that are improving the quality of life and inspiring a healthier world. To do this, these companies need a manufacturing partner who embraces their every challenge as its own, who shares the unwavering tenacity and dedication and can support them through the drug approval process. That’s The Power To Make. Althea is a fully integrated contract development and manufacturing organization committed to the success of its clients and for process development, drug substance manufacturing, and drug product manufacturing. With the capacity to support early stage clinical requirements through commercial manufacturing, Althea is giving Biopharmaceutical companies The Power To Make. Drug Development & Delivery recently caught up with David Enloe, Althea’s President and CEO, to discuss his company’s business strategy, why companies choose Althea, trends in the CMO industry, and how the company is growing since the acquisition of Ajinomoto.

Q: Can you provide our readers some history of the company and an overview of your business today?

A: Althea was founded in 1998 with an initial focus on developing plasmid kits and gene quantification assays. In 2000, the company expanded into microbial biologics manufacturing and eventually began offering fill and finish manufacturing. As Althea added analytical development services, the company became a fully integrated CMO. In 2013, Althea was acquired by Ajinomoto, a large Japanese company with more than 100 years of providing critical ingredients to the food industry, but with a growing life sciences portfolio of companies.

To date, Althea has partnered with hundreds of clients ranging from small to large biopharmaceutical companies, government agencies, and universities on both a local and international scale. We have worked on projects varying from the production of recombinant proteins, plasmid DNAs, vaccines, antibody fragments, to the fill and finish of injectable peptides, monoclonal antibodies, oligonucleotides, and small molecules. The number of lots of finished cGMP product that have been filled in our facility is in the thousands. Critical to all of this success and growth has always been Althea’s strong regulatory track record. We take great pride in the relationships we have established with multiple regulatory agencies, as well as in our numerous successful inspections which support advancing our clients’ products.

Q: What does Althea offer when it comes to contract manufacturing services?

A: Althea offers cGMP production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, we offer comprehensive development services, including upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release, and ICH-compliant stability testing.

Althea is a leading expert in executing drug formulation and aseptic fill finish, offering a broad range of sterile dosage forms, including prefilled syringes, liquid vials, and lyophilized vials. We have five Formulation Suites and five Independent Fill & Finish Suites with three automated aseptic filling lines. In addition, Althea offers a proprietary formulation technology platform, Crystalomics®, which offers a solution for large molecule products that must be delivered at high concentrations or as sustained-release formulations. We also have an innovative and proven recombinant protein expression technology called CorynexTM, which can deliver simplified production with better results. In a single location, we have the capacity to support early stage clinical requirements through commercial manufacturing.

Q: Why do companies choose Althea?

A: Althea offers a broad range of development and manufacturing services for biotherapeutic drug development. We are often told that clients come to us because of our responsiveness, technical expertise, and our commitment to always understanding our clients’ true needs. We completely align ourselves with our clients’ clinical programs, understanding the time-sensitive nature of their drug programs. Taking the time to understand our clients’ pain points and challenges shows the dedication and support we provide to them during their critical path through the clinic and into the marketplace.

We are also often told that we “get it,” we understand what our clients are going through, the pressures they are feeling, etc. At Althea, each client relationship is a partnership, and we are “in it together for the long haul.” From the time we embark with a client on their current phase of development and as they move through the drug approval process, we are right there with them every step of the way. The fact we are willing to get that detailed and that involved really lends itself to a different intensity with respect to our flexibly and our commitment, and I believe that is a real asset. We are often seen as an extension of our clients’ teams. This is one of the things about Althea that I am most proud of.

Q: What trends are you seeing in the CMO industry?

A: A trend that I’ve noticed for the past several years, and something I believe will continue in the future, is that biopharmaceutical companies, regardless of size, are identifying and understanding where their core expertise is and where they are lacking. Often, they are concluding that manufacturing is not within their core competencies, and certainly it is not an area that they wish to invest inside their organizations to expand.

There is great risk involved in carrying the entire amount of manufacturing infrastructure needed to introduce a new drug to the clinic that may not get all the way to a commercial success. Avoiding the “sticks and bricks” and instead keeping clinical development and other less-costly items in-house, they are coming to companies like ours and relying on our expertise as an extension of their team. We are able to spread out the manufacturing infrastructure costs basis over multiple clients, therefore making it more cost effective to produce their drugs as they proceed through clinical trials toward commercial distribution.

Q: What are the future plans for Althea?

A: Althea’s acquisition by Ajinomoto has led to several meaningful investments in our business, facilities, and overall operations. Recently, Ajinomoto and Althea’s boards of directors have approved the commitment to enter one of the most promising new cancer therapeutic markets, the Antibody Drug Conjugate (ADC) sector. Althea will soon be what we believe to be the only contract manufacturer in the United States to offer antibody drug conjugation services in conjunction with the fill and finish services required to get the product into vials to be used in clinical trials and commercial distribution. This new division of Althea will give us the capabilities to service the emerging biotech and pharma companies and support their needs with developing ADCs for oncology therapeutic drug programs.

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