Tim Wright, Editor03.09.16
Lonza’s pharma and biotech segment recently announced the expansion of its footprint to offer customers a complete portfolio of development and manufacturing services for clinical outsourcing requirements by entering into drug product services.
These drug product services will focus on parenteral dosage forms, including products for injection and infusion for intravenous, subcutaneous, intraocular and other routes of parenteral administration. Services will include options for monoclonal antibodies, other biologics, drug conjugates, peptides and small molecules that require a parenteral dosage form.
Drug product services will be offered in the fourth quarter of 2016 from laboratories based in Basel, Switzerland with an initial focus on formulation development and drug product analytical development and quality control. Specialized services will also be available for customers, such as particulate identification, characterization and quantification, excipient and surfactant characterization, extractables and leachables assessment and testing of container closure integrity.
Heading the drug product business is Prof. Dr. Hanns-Christian Mahler, who for 10 years led the departments of pharmaceutical development and supplies and formulation R&D biologics for Roche. Contract Pharma spoke to Dr. Mahler about Lonza’s move into drug product development services. —TW
Contract Pharma: What was the motive for entering the field of Drug Product Development Services?
Hanns-Christian Mahler: Drug Product Services complements Lonza’s current drug substance offerings and enables us to provide one-stop-shop services to our customers. By providing integrated development and manufacturing services of the highest quality, we support our customers in meeting some of the greatest challenges in patient treatment.
CP: How will this move facilitate growth and what does it say about the direction your business is headed?
Mahler: The addition of Drug Product Services makes us a fully comprehensive partner by extending our capabilities beyond drug substance. By combining our drug substance and drug product service offerings, we provide our customers a less complex procurement model. This allows rapid and effective progression of their candidates to the clinic and benefits our customers and, ultimately, their patients.
CP: What is the action plan for integrating this new service offering over the coming years?
Mahler: Drug Product Services will initially focus on formulation development, drug product analytics and quality control. Additional specialized services will also be available including: particle identification (subvisible and submicron), extractables and leachables, and container closure integrity.
We believe that Drug Product development is an area of significant challenges; and the combined development approach of formulation, drug product processing, primary packaging and integration of the Drug Product/Drug Substance activities will yield a successful product for the patient.
CP: Why choose parenteral dosage forms as the target area?
Mahler: While oral dosage forms such as tablets or capsules have become a commodity for small molecules, they do offer other areas of challenge, including solubility and permeability that warrant skilled services. Currently, parenteral dosage forms are, and will remain, a major challenge. The more complex molecules such as biologics, next-generation biologics, cell therapy products and other treatment options, require parenteral delivery.
CP: How would you describe the current state of the market for parenteral dosage development and manufacturing?
Mahler: The market for parenteral dosage forms is fragmented. Some companies focus on fill/finish services while others offer formulation services. A third group offers specialty services such as extractables and leachables or particle identification. In order to address current challenges of parenteral drug product development, we believe that an integrated approach that combines all of these services is the only way to efficiently address the challenges and meet the needs of our customers. This integrated approach delivers accelerated development timelines for early stage clinical testing, process robustness and reliability for commercialization.
CP: What would you say are three key trends and/or drivers in the contract parenteral dosage business?
Mahler: For one, we are seeing more variable and challenging molecules, along with new formats including more potent molecules (e.g. ADCs) and parenteral product administration moving away from intravenous (IV), towards subcutaneous (SC) or intravitreal (IVT, intraocular) injections. There are specific development challenges with SC and IVT related to stability (e.g. aggregation, particle formation), viscosity (e.g. manufacturability, injectability) and volume to be delivered.
Second, regulatory expectations are constantly increasing and vary from country to country. Third, more patient-centricity, a stronger focus on safety and convenience and a trend towards self-administration/home use all drive a need for drug/device combination products.
CP: Where are the opportunities for growth?
Mahler: Given the expertise and experience of our Drug Product Services team, we will be able to provide state-of-the-art services based on strong, industry-based strategies and regulatory experience. Drug Product will be an integrated part of Lonza’s offerings in mammalian, microbial, chemistry, conjugates, cell and viral therapy technologies.
CP: Conversely, what are the major challenges or obstacles in the market?
Mahler: More potent molecules require smaller doses and ultimately smaller batch sizes. Regulatory expectations are constantly changing and vary from country to country. The fragmented drug product market requires customers to work with several vendors in order to meet regulatory requirements and progress their product to the clinic.
CP: How are customer expectations evolving?
Mahler: As a drug substance services provider, we have been asked if we offer drug product services. Customers are requesting high quality drug substance/drug product integrated offerings from a provider with a strong focus on people who are handling pharmaceutical drug products, including healthcare providers and patients. Customers also want experienced staff with strong regulatory backgrounds, and state-of-the-art offerings including analytical sciences. Drug product development and drug product design can help to differentiate a product in the market and can support lifecycle management.
CP: What does the trend towards one-stop-shop service solutions say about the contract development and manufacturing market?
Mahler: One-stop-shop service solutions reduce complexity in supply chain by working with selective strategic partners. Working with one strategic partner from discovery through clinical supply allows a more in-depth knowledge of the product, which supports pharma companies having “clinical value vs. cost” discussions with payers.
Tim Wright is editor of Contract Pharma. He can be reached at twright@rodmanmedia.com.
These drug product services will focus on parenteral dosage forms, including products for injection and infusion for intravenous, subcutaneous, intraocular and other routes of parenteral administration. Services will include options for monoclonal antibodies, other biologics, drug conjugates, peptides and small molecules that require a parenteral dosage form.
Drug product services will be offered in the fourth quarter of 2016 from laboratories based in Basel, Switzerland with an initial focus on formulation development and drug product analytical development and quality control. Specialized services will also be available for customers, such as particulate identification, characterization and quantification, excipient and surfactant characterization, extractables and leachables assessment and testing of container closure integrity.
Heading the drug product business is Prof. Dr. Hanns-Christian Mahler, who for 10 years led the departments of pharmaceutical development and supplies and formulation R&D biologics for Roche. Contract Pharma spoke to Dr. Mahler about Lonza’s move into drug product development services. —TW
Contract Pharma: What was the motive for entering the field of Drug Product Development Services?
Hanns-Christian Mahler: Drug Product Services complements Lonza’s current drug substance offerings and enables us to provide one-stop-shop services to our customers. By providing integrated development and manufacturing services of the highest quality, we support our customers in meeting some of the greatest challenges in patient treatment.
CP: How will this move facilitate growth and what does it say about the direction your business is headed?
Mahler: The addition of Drug Product Services makes us a fully comprehensive partner by extending our capabilities beyond drug substance. By combining our drug substance and drug product service offerings, we provide our customers a less complex procurement model. This allows rapid and effective progression of their candidates to the clinic and benefits our customers and, ultimately, their patients.
CP: What is the action plan for integrating this new service offering over the coming years?
Mahler: Drug Product Services will initially focus on formulation development, drug product analytics and quality control. Additional specialized services will also be available including: particle identification (subvisible and submicron), extractables and leachables, and container closure integrity.
We believe that Drug Product development is an area of significant challenges; and the combined development approach of formulation, drug product processing, primary packaging and integration of the Drug Product/Drug Substance activities will yield a successful product for the patient.
CP: Why choose parenteral dosage forms as the target area?
Mahler: While oral dosage forms such as tablets or capsules have become a commodity for small molecules, they do offer other areas of challenge, including solubility and permeability that warrant skilled services. Currently, parenteral dosage forms are, and will remain, a major challenge. The more complex molecules such as biologics, next-generation biologics, cell therapy products and other treatment options, require parenteral delivery.
CP: How would you describe the current state of the market for parenteral dosage development and manufacturing?
Mahler: The market for parenteral dosage forms is fragmented. Some companies focus on fill/finish services while others offer formulation services. A third group offers specialty services such as extractables and leachables or particle identification. In order to address current challenges of parenteral drug product development, we believe that an integrated approach that combines all of these services is the only way to efficiently address the challenges and meet the needs of our customers. This integrated approach delivers accelerated development timelines for early stage clinical testing, process robustness and reliability for commercialization.
CP: What would you say are three key trends and/or drivers in the contract parenteral dosage business?
Mahler: For one, we are seeing more variable and challenging molecules, along with new formats including more potent molecules (e.g. ADCs) and parenteral product administration moving away from intravenous (IV), towards subcutaneous (SC) or intravitreal (IVT, intraocular) injections. There are specific development challenges with SC and IVT related to stability (e.g. aggregation, particle formation), viscosity (e.g. manufacturability, injectability) and volume to be delivered.
Second, regulatory expectations are constantly increasing and vary from country to country. Third, more patient-centricity, a stronger focus on safety and convenience and a trend towards self-administration/home use all drive a need for drug/device combination products.
CP: Where are the opportunities for growth?
Mahler: Given the expertise and experience of our Drug Product Services team, we will be able to provide state-of-the-art services based on strong, industry-based strategies and regulatory experience. Drug Product will be an integrated part of Lonza’s offerings in mammalian, microbial, chemistry, conjugates, cell and viral therapy technologies.
CP: Conversely, what are the major challenges or obstacles in the market?
Mahler: More potent molecules require smaller doses and ultimately smaller batch sizes. Regulatory expectations are constantly changing and vary from country to country. The fragmented drug product market requires customers to work with several vendors in order to meet regulatory requirements and progress their product to the clinic.
CP: How are customer expectations evolving?
Mahler: As a drug substance services provider, we have been asked if we offer drug product services. Customers are requesting high quality drug substance/drug product integrated offerings from a provider with a strong focus on people who are handling pharmaceutical drug products, including healthcare providers and patients. Customers also want experienced staff with strong regulatory backgrounds, and state-of-the-art offerings including analytical sciences. Drug product development and drug product design can help to differentiate a product in the market and can support lifecycle management.
CP: What does the trend towards one-stop-shop service solutions say about the contract development and manufacturing market?
Mahler: One-stop-shop service solutions reduce complexity in supply chain by working with selective strategic partners. Working with one strategic partner from discovery through clinical supply allows a more in-depth knowledge of the product, which supports pharma companies having “clinical value vs. cost” discussions with payers.
Tim Wright is editor of Contract Pharma. He can be reached at twright@rodmanmedia.com.
