eBooks

eBook: Of Microbrews and Medicines — Understanding Their Similarities and Differences in Bioprocessing Can Help Improve Yields and Quality While Reducing Cost

Meeting a biopharmaceutical scientist or engineer who proclaims a love for brewing is not surprising. Perhaps it’s because of the challenge of mixing raw ingredients together and waiting patiently for the final product, maybe it’s the hands-on nature of the equipment or the data analytics entertainment, or it just might be the simple joy of creating something. Whatever attracts a scientist or engineer to making medicines and/or craft brews, a surprising number of principles hold true for both bioprocesses despite…

eBook: Bioinks for Bioprinting — Three-Dimensional Printing in Research and Medicine

Three-dimensional (3D) printing is one method of digital biomanufacturing for both basic biological research and translational, clinical applications. The medical field has used it to create such constructions as 3D surgical models for preoperative planning, to assist surgeons in their procedure preparations, which improves postsurgical outcomes. Examples here include generation of cleft-palate models (1), orthopedic applications (2), and cardiovascular surgical planning (3). Other forms of 3D printing for biological applications — such as 3D bioprinting — go beyond such surgical…

Postapproval CMC Changes: Increasingly a Fact of Biopharmaceutical Life

The manufacture of vaccines and therapeutic proteins has suffered from a reputation of being part art and part science, with heavy doses of regulatory uncertainty thrown in. Postapproval changes (PACs) to chemistry, manufacturing, and controls (CMC) were initiated reluctantly and carefully in the era of “the process is the product.” Today, CMC PACs are a normal part of the biopharmaceutical industry business. Emma Ramnarine (head of global biologics quality control at Hoffmann-La Roche in South San Francisco, CA) notes that…

eBook: Challenges Facing Biosimilar Entries into US Markets

Since the 2009 enactment of the Biologics Price Competition and Innovation Act (BPCIA) (1), the US Food and Drug Administration (FDA) has licensed six biosimilar products under PHS 351(k) and approved one product under FD&C 505 (b)(2). It also provided complete response letters (CRLs) to four biologics license application (BLA) filings (Table 1) (2). By comparison, the European Medicines Agency (EMA) has approved 31 biosimilar products (3) and refused or withdrawn about five. There is no doubt that US market…

High-Throughput Technologies: Accelerating Process Development

One of the key elements of any biopharmaceutical drug development project is the timeline from identification of the appropriate DNA sequence to investigational new drug (IND) application filing and the start of clinical trials. Typically, this timeline ranges from 18 to 20 months, depending on the type of molecule being developed and the extent and requirements of the chemistry, manufacturing, and controls (CMC) packages supporting the nonclinical and clinical parts of a development program. There is constant pressure to shorten…

U.S. Approval of Three Rapid Microbiological Methods for MACI Product Release

Short time frames are a major challenge in developing alternative microbiological methods for autologous cell therapy products. Ideally, results are made available in under a day. Obtaining regulatory acceptance also can be a challenge, but it is made easier if methods are included in an application (e.g., a biologics license application, BLA) rather than changing a method that is already part of an approved process. Comparing different detection platforms can be a challenge if they have different readouts, and validation…

Comparing Adherent-Cell Technologies: Amplification of Virus Stocks and Viral Vectors

FUJIFILM Diosynth Biotechnology (FDB) is a multifunctional commercial development manufacturing organization (CDMO) that manufactures virus-based therapeutics. Its site in Texas specializes in both adherent and suspension cell culture for production of virus vectors and for development of analytical assays to support production and expression of our clients’ therapeutics. We work with a number of cell lines such as human embryonic kidney (HEK293) and human retinal cells (Johnson & Johnson/Crucell’s proprietary PER.C6 line), which can grow in suspension. However, many of…

eBook: Advances in Single-Use Platforms for Commercial Manufacturing

This special report from Sartorius Stedim Biotech explores recent advances in single-use process platforms for commercial production of biopharmaceuticals. Enormous developments have been made in single-use systems, allowing biomanufacturers to adopt the technology in critical applications within their commercial-scale facilities. The authors illustrate how companies can work with teams of experts from supplier organizations to implement end-to-end single-use bioprocesses at scales up to 2,000 L by carefully considering the approach from the earliest stages in process development. Finally, the report…

Are All Protein A Resins the Same? A Performance Comparison of Eight Different Protein A Resins

Protein A affinity chromatography continues to be the preferred method for commercial purification of antibodies due to its very high selectivity and robust resin performance over repeated purification cycles. It is now estimated that over US$125 billion of yearly sales will be generated from monoclonal antibody (MAb) products by 2020 (1). The clear majority will be purified by large-scale protein A affinity chromatography. With the continued growth and therapeutic commercial importance of MAb production, the availability of high-quality resin material…

eBook Download: A New Paradigm in Process Development

  As the need to accelerate biopharmaceutical development around the world continues to grow, biomanufacturers face a host of challenges so they, too, can grow. Increasing process productivity, reducing cost, mitigating risk, and bringing products to market faster are just a few of the issues frequently addressed. But with support in process development, cGMP manufacturing and training, accelerating bioprocess development can become less challenging. Several biomanufacturers have successfully navigated these issues in collaboration with GE Healthcare’s Fast Trak Services. Whether…