INDUSTRIAL IMPACT

BioDuro-Sundia Acquires 2nd US-based Commercial Drug Product Manufacturing Facility along with Commercial Supply Agreement

BioDuro-Sundia | November 09, 2021

BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today it has entered into a definitive agreement to acquire a fully-operational 45,000 ft2 commercial oral solid dose drug product manufacturing facility located at 9601 Jeronimo Road, Irvine, CA. As part of the acquisition, BioDuro-Sundia will employ most of the current staff and provide continuous operations to support production of multiple existing products through a commercial supply agreement. Subject to customary closing conditions, BioDuro-Sundia will assume operations on January 1, 2022.

The Jeronimo facility is located in Irvine, California on the same campus as BioDuro-Sundia’s first US-based commercial facility, announced in August 2021. The deal includes an additional 25,000 ft2 of future space with combined facilities representing ~100,000 ft2 holding a supply capacity > 4 billion doses annually. Commercial production capabilities include aqueous and organic solvent process for fluid bed and coating capabilities, amorphous solid dispersion, along with multiple high speed tableting and encapsulation machines.

The continuity of the operation, including a highly experienced team and established processes, allows a seamless transition for commercial manufacturing in a facility with outstanding production track record and audit history But, we are also adding new commercial-scale capabilities, such as spray dry dispersion and hot melt extrusion, which establish us as a top provider for amorphous solid dispersion manufacturing in North America.”

 Alex Rodriguez, GM of the Irvine Facility at BioDuro-Sundia

“The acquisition of these commercial drug production facilities is a significant milestone in our 25-year history pioneering bioavailability enhancement for oral solid dosage forms, and a credit to our team’s dedication to quality operations, client satisfaction, and growth,” said Kent Payne, who led the acquisition in his role as President, Development and Manufacturing US/EU at BioDuro-Sundia. “It is also representative of our commitment to clients across the company and the investments we continue to make to grow capacity, establish new technology, and help our partners achieve success. We look forward to supporting our commercial-stage clients with quality drug product manufacturing, as we do all of our clients who entrust us with critical programs from discovery to development to manufacturing.”

BioDuro-Sundia’s US-based clinical development facility is located only an hour drive south in San Diego, California. The development operation has a track record of 1,000+ clinical programs, specializing in solubility enhancement leveraging amorphous solid dispersions.

About BioDuro-Sundia
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and 10 global sites.

Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.

BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.


About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.

About Bridgewest Business Group
Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group's private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.


Spotlight

For centuries, farmers have used tools, from plows to tractors, to turn over,
or till, their soil to remove weeds before planting. While this has been a
common and effective method for generations, it can ultimately lead to soil
erosion and loss of essential soil nutrients. Advances in biotech crops and
crop protection products are allowing farmers worldwide a new approach
through conservation – or no-till – agriculture. By leaving the soil untilled,
farmers build up the nutrients in their fields and preserve topsoil, which
boosts yields and helps our environment

Spotlight

For centuries, farmers have used tools, from plows to tractors, to turn over,
or till, their soil to remove weeds before planting. While this has been a
common and effective method for generations, it can ultimately lead to soil
erosion and loss of essential soil nutrients. Advances in biotech crops and
crop protection products are allowing farmers worldwide a new approach
through conservation – or no-till – agriculture. By leaving the soil untilled,
farmers build up the nutrients in their fields and preserve topsoil, which
boosts yields and helps our environment

Related News

GSK Starts Phase 2/3 Study of COVID-19 Antibody Treatment with Vir Biotechnology

GlobeNewswire | September 01, 2020

-Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc announced that the first patient was dosed last week in a Phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enroll approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021. Last week’s initiation of the study follows the signing of a collaboration between the two companies in April 2020 to research and develop solutions for coronaviruses.

Read More

KYAN Therapeutics Exclusively Enters License Agreement with Georgetown University for AI-Powered Cancer Drug Development

KYAN Therapeutics | September 24, 2020

KYAN Therapeutics, Inc. ("KYAN"), a frontier biotech company with a novel drug-dose combination optimizing platform, Optim.AI, has entered into an exclusive license agreement with Georgetown University for novel selective Class II HDAC inhibitors. KYAN has already commenced preclinical development of the lead candidate, which has been designated as KYAN-001, with early positive results. In vitro and in vivo studies of KYAN-001 have shown high efficacy for Multiple Myeloma and Prostate Cancer. The low toxicity and metabolic stability of KYAN-001 indicates a better safety and tolerability profile than FDA approved pan-HDAC inhibitors which suffer from toxicity issues and side effects. KYAN-001 also uniquely inhibits HDAC4 nucleoshuttling to further drive its anti-cancer effects. "We're very excited to proceed with KYAN-001 because of its promising features and we are confident that we can identify optimal combination therapies across multiple cancer indications with Optim.AI," said Lisa Chow, COO and General Counsel of KYAN.

Read More

Yufan Biotechnologies and Abound Bio Sign Multi-Year Agreement to Develop Next Generation CAR T-cell Therapies for Cancer

Yufan Biotechnologies | September 17, 2020

Exhaustion of T-cells is a key reason why CAR T-cell therapy may fail to control cancer. Recent work led by Xuebin Liao, PhD, Professor of Pharmaceutical Science at Tsinghua University (Si et al., Cancer Cell 2020) shows that HPK1 (hematopoietic progenitor kinase 1) promotes T cell exhaustion via NFkB-Blimp1 activation and that blocking HPK1, either by gene knockout or by small-molecule inhibitors, is an attractive strategy to improve CAR T-cell immunotherapy. These innovative approaches are being evaluated clinically by Yufan Biotechnologies, co-founded by Professor Liao and Yan Zhang, CEO. Yufan Biotechnologies has now partnered with Abound Bio, Inc, a life sciences company with world-renowned expertise in finding antibodies to direct CAR T-cells against cancer targets. Abound Bio was co-founded by Dimiter Dimitrov, PhD, and John Mellors, MD, CEO. The three-year partnership covers the incorporation of antibodies to novel cancer targets into the enhanced, HPK1-inhibited CAR T-cell platform.

Read More