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AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. (AAI-CML) have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With nearly 800 employees operating out of seven sites in the US and Europe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, ...
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. (AAI-CML) have joined to form a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With nearly 800 employees operating out of seven sites in the US and Europe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services.
This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules.
🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules
Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years?
We have achieved incredible milestones over the last two years, thanks
to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent
CDMO by building on the 50 years of expertise that we brought with us. In
addition, we expanded our capabilities and applied a more agile approach
available to us as a company singularly focused on life sciences. This has
allowed us to move into our second year with clear and strategic goals for
generating growth in our sites, people, capabilities, and offerings.
Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some
exciting growth milestones of my own. Most recently, we announced an estimated
US$ 30 million investment in our Devens, Massachusetts, site. This expansion
will allow us to build upon existing development and manufacturing capabilities
in ADCs and HPAPIs that will address the growing demand for strong US-based
capacity in these key drug modalities.
We also appointed our Advisory Board, thereby bolstering
Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas.
We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024.
🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board
Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years?
The pharmaceutical pipeline is witnessing an increasing number of
complex and highly potent molecules. This trend is driven by the demand for
more targeted, patient-centric therapeutics and the focus on innovative
modalities such as ADCs and other bioconjugates.
At Veranova, our expertise, world-class facilities, and scientific
excellence enable us to provide our customers with the clarity and solutions
needed to manage this development and manufacturing complexity and ultimately
deliver the required treatments to customers and patients.
Our people are key to this approach. We have an expert team ready to
collaborate with customers at any point, from early development through
large-scale commercial production. Our services include world-leading
crystallization development, process development, and specialized manufacturing
expertise for complex synthetic molecules, including those requiring
chromatography capabilities. In many cases, we can provide all these under one
roof.
Our service offering to our customers is also based on the foundational
element of strong quality and compliance systems. We operate multiple
facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually
focused on ways to strengthen our global quality management system.
Looking ahead, we are focused on continually investing in our facilities
and team to meet growing complexity, as evidenced by our recent announcement of
new investment in our Devens site. This investment signals our commitment to
providing state-of-the-art capacity and capabilities to enable these
next-generation therapies to reach patients. It is a key milestone as we
advance Veranova’s broader growth strategy.
🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems
How is Veranova approaching the challenge of designing and
manufacturing effective linker molecules for ADCs?
As a leader in complex linker-payload synthesis, Veranova is committed
to unlocking the life-changing potential of ADCs without letting their
complexities slow down the development of much-needed cancer therapies.
ADCs are intricate, multi-component molecules that require extensive
expertise and agile collaboration to overcome unique development challenges.
With over a decade of experience in ADC linker-payload systems, we have
developed the ability to anticipate challenges and avoid common pitfalls.
The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic.
We prioritize getting it right the first time, minimizing change orders
and ensuring high-quality results. We have developed a robust phase-appropriate
strategy that is backed by state-of-the-art analytical equipment and regulatory
procedures to ensure our partners can rapidly progress their ADC projects from
pre-clinical to commercialization.
🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects
Can you specify how Veranova is using artificial intelligence (AI) to optimize
manufacturing processes that can reduce costs and environmental footprint as
well as speed up development?
In May 2024, Veranova announced a partnership with Phorum.AI to leverage
AI to optimize pharmaceutical manufacturing processes. This collaboration aims
to enable the rapid development of processes that can drive efficiency and
reduce costs while maximizing environmental sustainability.
Our goal is to combine Veranova’s extensive empirical manufacturing dataset
of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers.
At Veranova, we are constantly looking to employ innovative technologies
and approaches to improve efficiency, accelerate time to market and reduce
environmental footprint. We have the means to work with a variety of partners
who have unique project requirements, without sacrificing time to market.
🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint
The pharmaceutical industry has long recognized the critical role
excipients or inactive ingredients play in drug formulation and delivery.
Excipients can comprise up to 90 percent of a medicine's total
ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings.
According to recent market research, the pharmaceutical excipients
market was valued at US$ 9.27 billion in 2023. It is growing at a compound
annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032.
The main factors driving market growth is an increased demand for
multifunctional excipients, coupled with the expanding use of generic
medications. The development in the biologics sector and advancements in
nanotechnology are also contributing significantly to market growth.
Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay
Pharmaceutical and Nippon Fine Chemical.
View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)
WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination
Last year, the World Health Organization (WHO) issued a health
alert linking at least 300 child deaths in the Gambia, Uzbekistan,
and Indonesia to the ingestion of contaminated cough syrups containing
unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG).
In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.
Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources.
Furthermore, the Indian Health Ministry proposed amendments to the
Drugs and Cosmetics Rules,
1945 to include details of excipients on drug labels. While listing
all excipients on every strip of medicine may be challenging, the ministry
suggested mentioning those causing hypersensitivity on the label. Applicants now
mandatorily need to submit evidence of stability and safety of excipients.
These regulatory developments have significant implications for
excipient manufacturers and pharmaceutical companies worldwide. Leading
pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet
these heightened quality and safety standards, given their long-standing
commitment to producing high-quality, compliant excipients.
View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)
Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt
In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market.
Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions.
The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.
Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics.
Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals.
Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities.
In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite
levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms
per gram or less, which is equivalent to 0.1 parts per million (ppm). The
company also started full commercial operation of its second manufacturing
facility for Ceolus in Japan, enhancing supply capacity and stability.
JRS Pharma and Gujarat Microwax opened
a state-of-the-art cotton-based croscarmellose
sodium plant in Mehsana, Gujarat (India). This facility aims to produce
high-quality excipients that meet global standards, potentially reducing
India's dependency on imports and boosting its presence in the global excipient
market. The Indian excipient industry accounts for less than 1 percent of the
global market share.
View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)
Seqens to advance innovative
polymer; biologics, personalized medicine create demand for specialized
excipients
Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of
polymer development experience, was chosen by Pleryon Therapeutics to advance
its leading osteoarthritis
candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.
The rise of biologics and personalized medicine has created a
demand for specialized excipients capable of stabilizing complex molecules and
enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl
pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea
starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients.
The trend towards patient-centric drug development has also
influenced excipient innovation. Excipients that can improve palatability, ease
of swallowing, or enable novel dosage forms (such as orally disintegrating
tablets) are in high demand. For example, IFF brought a super
disintegrant Ac-Di-Sol, that supports faster disintegration and drug
dissolution in oral disintegrating tablets, improving patient experience.
View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)
Our view
The heightened regulatory scrutiny on excipients due to product
contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies.
Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance.
Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.