The authors examine the selection process of the contract manufacturing-pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.

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The authors examine the selection process of the contract manufacturing–pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.

Customer Relationship Management in Contract Manufacturing

Andrea Zobel, Senior Director Product Management, Clinical Trial Supply & Logistics, PAREXEL, discusses how clinical trial and logistics requirements for novel therapeutics differ from those for traditional therapies, and shares best practices for planning and collaboration.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Preparing an Approach to Cold Chain for Cell- and Tissue-Based Therapies

Biopharmaceutical experts Stephen Perry, CEO of Kymanox, James Blackwell, principal consultant with The Windshire Group, and consultant Mike Ultee, share best practices and musts to avoid in biopharmaceutical technology transfer.  Some crucial takeaways?  Share all data (especially data on failed runs in the past), and include clear instructions for sampling.  In addition, aim for reproducibility.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

Getting Biopharmaceutical Tech Transfer Right the First Time

Demand for biologic drug processing is placing pressure on contract manufacturing organizations to meet capacity demands in a timely manner. Christoph Winterhalter, senior vice-president of business development at Rentschler Biotechnologie GmbH, discusses the ways the company is prepared to handle new challenges related to client requests and heightened scrutiny from regulatory authorities.

BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.

CMOs Tackle New Challenges

Compared to traditional small-molecule generics, the R&D costs and development times for biosimilars are significantly greater. With demand for services in the biosimilars space set to soar, many contract development and manufacturing organizations are increasing their capabilities in this field.  Expansions including in-house development, partnerships and joint ventures, or bolt-on acquisitions are summarized.

Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.

Gearing Up for Biosimilars

Aseptic manufacturing is an important part of drug development and commercialization that must be approached with utmost care and attention to detail. Getting a drug product packaged and passing successfully through clinical manufacturing and into the marketplace will depend on many factors, some which are fundamental and straightforward while others require careful consideration of different criteria that can affect each individual situation. The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

Insourcing vs Outsourcing: Choosing the Right Strategy

CMO partnerships can be challenging both for the CMO and the product owner. The article maps out optimal organizational designs for CMOs and product owners that increase the likelihood of a successful partnership and ensure consistent, reliable, and quality supply of drug product.

Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.

Operations and Quality Oversight of CMOs

As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues.  Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

Quality Metrics and CMO Agreement

A pharmaceutical manufacturer can perform its own audits as part of supplier qualification; or authorize a suitable third-party audit provider to perform the audit on its behalf; or buy an audit report from a commercial provider. The main focus of interest is the final audit report, which in any case, should be written informatively and distinctly, and should enable the reader to gain a comprehensive impression of the audited firm. This article reports some experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.

BioPharm International-05-15-2017