Lonza to Present Live Webinar on Cell-based Potency Assays: Expectations and Realities

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Life Sciences event will define and discuss challenges and regulatory expectations of cell-based potency assays, as well as review a case study of an adenoviral gene therapy product

Lonza will offer a live Webinar featuring viral-based therapeutics in cell-based potency assays for biological manufacturing—on Thursday, September 6, 2012 at 8:00 AM EST and 1:00 PM EST. Each session is 60 minutes and includes Q&A.

Bob Schrock, Ph.D., Head, Quality Control of Viral-based Therapeutics at Lonza Houston, Inc., will demonstrate Lonza's viral manufacturing capabilities in the area of cell-based potency assays and will discuss a case study that illustrates a timeline from development to validation.

Webinar will feature:

  • Definition of “Potency”: measuring biological activities specific to a viral-based product
  • Challenges encountered when developing and validating cell-based potency assays
  • Expectations from regulatory agencies and available guidelines to reference
  • Potency assay approaches to consider
  • Real-world case study of an adenoviral gene therapy product

To register for Session 1 (8 AM EST), visit https://www4.gotomeeting.com/register/796777679

To register for Session 2 (1 PM EST), visit https://www4.gotomeeting.com/register/637109799

About Viral-Based Therapeutics
Lonza's Viral-based Therapeutics business brings a unique perspective in that its scientific and regulatory team has both CMO and relevant product development experience through BLA. We are the only CMO team with experience producing viral-based products and developing processes suitable for commercial use. Our scientific and regulatory expertise paired with a strong customer focus, makes Lonza Viral the leader for outsourced viral-based gene therapy and viral vaccine product development. We support a wide range of product types such as adenoviral vectors, AAV vectors, and lentiviral vectors. Our services range from cell line optimization and vector development to process development and cGMP manufacturing through product release testing. We produce cGMP materials and perform release testing for preclinical through Phase III clinical batches. Further information can be found at http://www.lonza.com/viral

About Lonza
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of chemical and biological active pharmaceutical ingredients. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection, and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets.

Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza is not subject to the SGX-ST’s continuing listing requirements. Lonza is subject to the listing rules of the SIX Swiss Exchange, which do not have specific requirements equivalent to the listing rules of the SGX-ST in respect of interested person transactions, acquisition and realizations, and delisting. In 2011, the company had sales of CHF 2.69 billion. Further information can be found at http://www.lonza.com.

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