Press Room

Developing an Orally Inhaled Dry Powder Formulation - A Complex Itinerary and a Technological Challenge The delivery of an orally inhaled API to the deep lung can be performed using different drug-delivery platforms, such as nebulizers, pressurized metered dose inhalers (pMDI), and dry powder inhalers (DPI). DPIs are increasingly becoming a more important drug delivery option and are expected to hit double-digit figures, reaching global sales of $31.5 billion in 2018 DPIs are conventionally formulated using a carrier-based approach, in which the API is size-reduced until it reaches an inhalable particle size and is further blended with a lactose carrier to enable dose metering and to improve powder flowability and dispersibility. Even though this formulation approach is the most commonly used, it presents several drawbacks. To overcome the limitations, as well as to address the renewed interest in pulmonary delivery of biotherapeutics and other advanced therapies, several alternative particle engineering approaches have been devised over the years, such as the production of composite particles by spray-drying where the API is embedded in an excipient matrix. Although the development of a DPI seems straightforward, it is a complex area that integrates multiple fields of knowledge. In a general way, the success of a DPI produced using a carrier-based formulation approach will be determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance. In this article, Gonçalo Andrade, business development manager at Hovione, spoke to Pharmaceutical Technology about the key considerations when developing an orally inhaled dry-powder inhalation formulation. Read the article here

Article
Pharmaceutical Technology, June 2015

Developing an Orally Inhaled Dry Powder Formulation

Jun 01, 2015

  The Life Science Leader Magazine recognizes Hovione for its achievements and awards:     Innovation Award (The business will improve our in-house capabilities with customized solutions)       Regulatory Award (The business is reputable and compliant) Life Science Leaders CMO Leadership Awards are based on industry research conducted by Nice Insight.   To view the Life Science Leader Magazine article click here    

News
Hovione wins two 2015 CMO Leadership Awards from Life Science Leader in the categories of Innovation and Regulatory.

Hovione receives 2015 CMO Leadership Award

Mar 17, 2015

The respiratory drug sector is experiencing a surge of interest as companies seek to capitalise on the rapidly growing market. With new product launches and novel formulation combinations in development, inhaled drug delivery is reaching far beyond its origins in asthma and COPD treatments. Authors: Gonçalo Andrade, PhD, Business Development Manager Peter Villax, Vice President of Innovation Carla Vozone, Senior Director, Product Development and Licensing Read the article here

Article
PMPS, 2015, February, pp. 30 - 33

The Time Has Come

Feb 10, 2015

Loures, Portugal, January 12th, 2015 – Hovione today announced the appointment of Dr. Filipe Gaspar as Vice President of its Research and Development organization. Dr. Gaspar will lead teams based in Lisbon and New Jersey that serve our clients’ drug development projects; he will also be defining long-term product development strategies and collaborations. He will report to Guy Villax, Hovione’s Chief Executive. “We are very pleased to have Filipe running our R&D. Filipe brings great science and leadership skills. For the last 10 years Filipe has been the driving force behind our Particle Engineering, and if we have four new drugs today on the market it is because he and his team made sure we had the right capabilities, knowhow and ability to deliver” said Guy Villax. “I am honored to have the opportunity to lead this talented R&D team and help fulfilling our mission of serving our customers developing and delivering innovative medicines for patients”, said Filipe Gaspar. Dr. Gaspar is the co-author and co-inventor of numerous publications, scientific presentations and patents. He is a Chemical Engineer from Instituto Superior Técnico (Lisbon) and has a PhD in Chemical Engineering from the University of Birmingham.  Dr. Gaspar joined Hovione in 2003 as a Manufacturing engineer and later became responsible for the technical leadership of spray drying technology. In 2004 Dr. Gaspar moved to R&D to start the Particle Engineering group, there he was involved in more than 120 projects from preclinical stage to commercial. During that period he was the Lead Scientist in four projects that reached commercial stage, including the first at Hovione submitted under Quality by Design. He was instrumental in many of the projects that contribute to Hovione’s growing success in Particle Engineering.  In 2012 he moved to a Business Development role and spent a year based in New Jersey.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets.  In the last 5 years it stood behind 1-2 NDA approvals each year, and its DMFs and CEPs are referenced in dozens of ANDAs and marketing authorization that are approved each year. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs.  It is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release

Hovione appoints Filipe Gaspar, PhD as Vice President R&D

Jan 12, 2015

In this article, Cláudia Moura, PhD Student; Eunice Costa, PhD, Scientist, Drug Product Development; Filipe Neves, PhD, Senior Scientist, Group Leader, Drug Product Development; all of Hovione, describe how composite formulations - API embedded in an excipient matrix - overcome the challenges in inhalation powder development, and make the case for spray drying as a highly suitable, tunable and scalable particle engineering method for producing them. Read article here

Article
ONdrugDelivery, 2014, December, pp. 16 - 23

Design of Composite Particles via Spray Drying for DPI Formulations

Dec 31, 2014

  Loures, Portugal, December 17th, 2014 – Hovione today announced that the U.S. Food and Drug Administration (FDA) performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings. At the conclusion of the inspection, the FDA issued a Form 483 with three inspectional observations.  The inspection carried out by the FDA Investigator Mr. Ramon Hernandez and by the Chemist, Mr. Jose A. Lopez Rubet, lasted 5 days as initially planned, started on 1st December and concluded on the 5th. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP). On the outcome of the inspection, Luisa Paulo, Hovione's Compliance Director, said "Addressing these observations is the top priority of the site management and the points raised will be replied to within 15 working days from the receipt of the Form 483. We are taking this result to improve our quality system both here and at our other sites.  The investigators spoke positively of many of our initiatives.  We have a strong pipeline of products under development with new NDAs being filed in the next 12 months, and we need to work diligently to continue to deserve our clients’ trust”. “We have a culture of quality that puts patient safety first. This shapes our behaviors and motivates us to improve. This is a Team effort, and I am very encouraged to see everyone so committed.” said Guy Villax, Chief Executive.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Press Release
Hovione today announced that the FDA performed a Pre-Approval Inspection to its plant in Loures, Portugal, covering two NDA filings.

Successful FDA inspection at Hovione

Dec 17, 2014

Cork, Ireland, 27th of November 2014 – Hovione announced today it has filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA). This event represents a milestone in Hovione’s strategy of developing improved drug delivery options for established drugs. The IND was submitted for minocycline gel, a novel formulation using a new patented crystalline base form of minocycline, to administer topically one of the most widely prescribed oral antibiotics for acne. Currently, there are no approved topical formulations of minocycline for the treatment of acne. While oral administration of minocycline has a well-established efficacy and safety profile in acne, it is also associated with certain adverse events, due to systemic exposure. Pending FDA’s acceptance of the IND submission, Hovione plans to initiate human clinical Phase 1/2 studies in early 2015. “This filing represents a turning point in Hovione’s history.  It builds on 50 years of manufacturing Active Pharmaceutical Ingredients, Particle Engineering and Formulation” commented Carla Vozone, Hovione’s Senior Director of Product Development and Licensing. “This is a novel route of administration for a drug with proven safety and efficacy over more than 30 years of clinical use. We believe the targeted delivery to the site of action will reduce systemic exposure and thus potentially reduce the adverse events profile”.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release

Hovione files its first Investigational New Drug Application with the FDA

Nov 27, 2014

Paul joined Hovione on the 1st of October 2014. He holds a BSc in Chemical and Pharmaceutical Science from the University of Sunderland (UK) and a PhD in Organic Chemistry (asymmetric synthesis using organometallics) from Sheffield University (UK). He started his industrial career with Fisons Pharmaceuticals in Loughborough, where he worked in the R&D Analytical Laboratory. In early 1997, Paul joined Ciba-Geigy in Grimsby as a Process Chemist in the Chemical Operations area (Ciba-Geigy merged with Sandoz at that time and became Novartis later in 1997). He subsequently held several senior lead roles in both Quality and Production with Novartis. In 2007 he moved to New York to head up the Operations Unit  for Pharmaceutical Operations. As a result of Paul’s success in this function he was asked, in 2009, to take on the role of Global Head of Pharmaceutical Operations Strategy for Technical Operations at Head Office in Basel, where he stayed until 2012. Paul then chose to return to Cork with his family  and was invited by Chanelle Group to become Director of Operations near Galway. Paul brings to Hovione over 20 years of relevant experience of development, quality, APIs manufacturing and formulation, as well as pharma strategy with Novartis and Chanelle. He also has considerable expertise in operational efficiency and world-class team leadership in pharma operations.   Hovione Cork - click here  

News

Hovione Cork – New General Manager - Paul Downing – since 1st October 2014

Oct 01, 2014

The author (Guy Villax) presents arguments for an FDA Dean's List as a means to drive the right behaviors in the industry. FDA is moving in the right direction when it looks to rank quality across pharmaceutical manufacturing sites. However quality is a matter of culture rather than metrics or compliance. Read the extended version with links to references, examples and case studies here Read the article in Pharmaceutical Technology  here  

Article
Pharmaceutical Technology, September 2014

Quality Metrics - A Case for an FDA Dean's List

Sep 23, 2014

If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing. Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.   Read article here  

Article
Outsourced Pharma, 8 September 2014

Are Regulators Providing The Right Quality Incentives?

Sep 08, 2014

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