Bora Pharmaceuticals is one of the premier pharmaceutical companies in Taiwan—its operations covering the entire pharmaceutical supply chain from research and development all the way to sales and distribution. With its U.S. FDA, MHRA, and PIC/S certified facilities, Bora provides R&D, CDMO and CMO services to Taiwan domestic and global pharmaceutical companies around the world.
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Bora recently established its footprint in the North American market by setting up a sales office in Delaware and hiring Samuel Ricchezza to lead the expansion effort. Contract Pharma caught up with Mr. Ricchezza to talk about joining the fast-growing CDMO and learn first-hand how plans are unfolding.

Contract Pharma: In Fall 2019 Bora announced the launch of its first U.S. office and soon after your appointment to lead the company’s North American operations. What’s ahead for you and Bora in 2020?

Samuel Ricchezza, President of North American Operations: Bora is on a great trajectory and our growth has been steady and strategic. In the last eight years the company has extended its capacity and capabilities with key acquisitions in Taiwan including our FDA/MHRA approved facility in Zhunan and our Pharmaceutical Inspection Co-operation Scheme (PIC/S) cGMP facility in Tainan.

With oral solid dose (OSD) development and manufacturing operations now anchored in Taiwan, Bora is actively seeking opportunities to expand its presence and manufacturing footprint in North America. Our goal is to be where our customers need us most—helping them wherever their drug strategies take them.

Over the past decade Bora has made a considerable investment growing its operations and expanding its global capabilities. We recently opened our office in the U.S. as part of a two-year plan to invest in the North American market and better support our customers in this region. The U.S. office signals the next phase of the company’s international expansion plans, both in support of Bora’s future growth to better serve its growing, global client base, as companies across the U.S. continue to outsource their most complex OSD projects to Bora.

As president of operations in North America, I’ll be leading our growth in 2020 and expanding our presence in the region. I’ll be responsible for bringing our expertise with OSDs closer to customers here as well provide an experienced partner with operations in Taiwan that can provide reliable access to Asia and the Pacific’s most challenging markets.

Contract Pharma: What strategies do you think will be driving sponsor drug development in the coming decade? And how are contract service partners responding?

Ricchezza: Although that portion of pharma development will gain share over time, what can’t be denied is the continued momentum and growing strength of small molecule OSD development.

Pharma will always pursue best-in-class drug strategies via small molecule, orally administered, patient-centric dose forms. OSD medications are preferred by patients and offer broad therapeutic value to payers. For the past five years OSDs have dominated FDA approvals. In 2018, 71 percent of new molecular entities (NMEs) were small-molecule, chemically synthesized OSDs.*

Whether a sponsor needs to see a new potent, novel API through approval and commercial launch or modify the release of a formula in pursuit of a 505(b)2 life-cycle management (LCM) extension, OSDs are becoming harder to formulate, process and manufacture.

That’s driving demand for increasingly sophisticated technical and analytical capabilities from contract manufacturers. It is clear CDMOs are working hard to stay ahead of this curve. Bora’s focus is fixed squarely on being world-class at manufacturing complex OSD forms and our investments and acquisitions will continue to demonstrate that.

Contract Pharma: Are there specific technologies, processes or capabilities contract service providers must have to compete for business in the near term? What about five years from now?

Ricchezza: Pharma is seeking expertise, experience and quality from its outsourcing partners. That’s true now and will be true five years from now. To remain competitive and meet the needs of pharma’s innovators, OSD contract manufacturers will always have to consistently invest in their technical expertise, processing technologies and operations. Regulators label compliance current GMP after all.

Many APIs being developed for immunotherapy and oncology are potent and insoluble. To be therapeutically effective and more patient centric, the release of these compounds needs to be controlled or modified–often to help bioavailability or control dosing (and unwanted side effects) over time.

There are a number of OSD technologies that can effectively control and modify release in formulation. Bora offers advanced extrusion-spheronization formulation and manufacturing expertise for example.

This well-known pelleting methodology is proving to be just what the industry needs right now to manage the precise control and delivery of APIs. It’s also a perfect vehicle to engineer today’s most advanced and effective dose forms including fixed, combined-dose (FCD) capsules and multi-unit particle system (MUPS) tablets. Spheronization is also perfect for preparing APIs for dispersion by emerging sprinkle capsule forms designed to answer dose compliance among geriatric and pediatric patient groups.

Contract Pharma: What are drug owners and developers wanting more of from contract manufacturing suppliers? What do they seem to be wanting less of?

Ricchezza: For the most part it seems owners and developers are seeking a true partnership rather than a vendor set-up. They need experience and are also seeking deeper collaborations, and increasingly that includes financial collaborations as well.

It’s also apparent that pharma is looking for the best technical partners to wed their drug strategies to. Pharma’s sponsors seem to want to set up “housekeeping” with competent partners experienced at meeting the bigger challenges associated with long-term manufacturing relationships like scale-up.

Contract Pharma: Pharmaceutical manufacturing is increasingly a global affair. U.S. companies are seeking partners in Asia, while others seek partners in North America. How is Bora meeting the strategic interests of these customers?

Ricchezza: It’s true and Bora is responding to pharma’s emerging pharma business opportunities in both regions—that’s why we’re building our presence in Asia and North America. How is Bora meeting our customer’s strategic interests in this case?  Quite simply, by offering a world-class manufacturing platform to launch global drug programs.

A center for OSD excellence and commercial manufacturing, our Zhunan facility offers a full range of capabilities to a global customer base. This includes dry and wet granulation, extrusion-spheronization bead manufacture, Wurster fluid-bed coating, tablet compression, single and multi-component encapsulation, functional and non-functional film coating and serialization-ready packaging.

Our sites continue to maintain an excellent inspection track record with global regulators. But that’s not too surprising from my perspective – even though regulatory pressures continue to mount, Bora puts all the right operational and technical pieces in place, then teams them with great science and experienced, well-trained employees. In fact, over a quarter of our staff are in a devoted quality role.

Because our Taiwan facilities are sanctioned by the world’s leading regulators, Bora is currently approved to export products to 18 countries—including the U.S. and EU, Canada, China, and Japan.

Of all drugs manufactured and exported from Taiwan to global markets, Bora manufactures 11 percent. Further, 52 percent of all pharmaceuticals exported from Taiwan into the U.S. are manufactured by Bora.

With our great facilities and OSD experience in Taiwan we like to think Bora is uniquely positioned to help pharmaceutical companies meet their global strategies, make their products efficiently and reach new markets faster.

Contract Pharma: What do you think makes one potential outsourcing partner more strategic than another?

Ricchezza: Besides the fundamentals of capability, capacity and experience, I would have to say it is commitment. For Bora we find we’re strategic with our customers because with every relationship we’re committed to doing things right from the beginning, solving customer challenges efficiently and maintaining strong relationships based on mutual respect

Contract Pharma: In pharma manufacturing, quality is Job 1. How important a role will contract pharma play in maintaining drug quality, and how is this manifesting itself at Bora?

Ricchezza: Indeed quality is pharma’s highest priority and for the most part it’s the industry’s contract manufacturers who are leading the charge—and that includes Bora. Our role couldn’t be more important; innovators, developers and regulators are all relying on contract pharma to deliver better, safer outcomes to patients.

Bora’s ethics stem from a culture that values the pursuit of purity and precision. This philosophy manifests itself uniquely well at Bora—from my long experience in contract pharma I could tell right away that there was nothing “missing” from a quality standpoint.

Our quality strategy integrates quality control, quality assurance, compliance and audit, quality systems and analytical development. Bora’s quality unit capabilities and organization are industry leading and I think our inspection and release track record speaks for itself. 

*https://www.dcatvci.org/5852-small-molecules-still-leading-in-new-drug-approvals