BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, has announced the addition of Ashley Ruth, PhD to its growing team of technical experts and consultants. Ashley joins BioTechLogic from the US Food and Drug Administration, Center for Drug Evaluation and Research, where she was a Research Chemist within the Division of Pharmaceutical Analysis. As a Senior Consultant in Analytical Services, Ashley will support clients in a variety of areas. She will provide expert advice for the development, qualification and/or validation of analytical methods pertaining to biopharmaceutical analysis and CMC development used throughout the drug development and approval process under GxP guidelines. She will also provide expert advice on the establishment of analytical biosimilarity for drug product using the 351(k) pathway, the generation of comparability plans and protocols, analytical method transfer, and SOP generation and compliance. She will also draft, review, author and perform expert reviews of the Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions. Ashley is also an expert in data compliance and integrity, with experience implementing such workflows for the FDA laboratory while at the agency.

While with the Agency, Ashley served as an expert in bioanalytical method development, qualification and validation, with expertise in mass spectrometry, chromatography and spectroscopy. Her work focused on the use of advanced analytical technologies for the characterization of complex biological drug products, with emphases on complex peptide products and higher order structure characterization. Her work also included studies correlating physicochemical characterization with functional assays. She has authored 17 peer-reviewed publications and is involved with several professional societies, including the American Society for Mass Spectrometry and CASSS. Prior to joining FDA, Ashley was a Chateaubriand Fellow of the Office of Science of Technology of the Embassy of France in the United States at École Polytechnique in Palaiseau, France. Ashley has a BA in Chemistry from Pomona College in Claremont, California and a PhD in Chemistry from the University of Arizona.

At Long Last, Nucleic Acid Therapeutics Are Coming of Age

Although meaningful progress toward the development of oligonucleotide therapeutics began in the 1970s, nearly a half century later, only three oligonucleotide drugs have been approved by the FDA. However, the field is gaining momentum and the clinical benefits of the more than 135 oligonucleotide therapeutics currently in various stages of clinical trials are extremely promising.

THE PROMISE & OPPORTUNITIES
What is so attractive about oligonucleotide therapeutics? Although this class of therapeutics is quite diverse, the excitement and dedication to this work is rooted in the following factors:

• Oligonucleotides offer promising treatment for a wide range of medical conditions.

• They allow for the development of therapeutics that affect protein targets that cannot be effectively treated by small-molecule or protein therapeutics.

• Interfering with RNA function at the cellular level, specific malfunctioning genes can be targeted, manipulated, silenced and/or modulated.

• Immune system modification is possible, offering the possibility of treatment for a multitude of autoimmune disorders that are in many cases extremely challenging to treat with currently available drugs.

• Oligonucleotides are synthesized pieces of chemically modified RNA or DNA. Scaling up for commercial-scale GMP production is more feasible than it is for many cell therapies or other biologic therapies.

• Side effects for many oligonucleotides are more controllable and minimal than the side effects experienced with other classes of drugs.

• As reported by Ryszard Kole in 1993, oligonucleotides can be used to modulate pre-mRNA splicing. Much work has been done to develop therapies targeting Duchenne muscular dystrophy, including progress treating the splicing mutation that causes Duchenne muscular dystrophy. These learnings hold much promise for a number of other conditions as well.

• In concept, when compared to small-molecular drugs as well as to large-molecule biopharmaceuticals, oligonucleotide pharmaceuticals are much more straightforward to both design and develop.

Continue Reading Article

Proteins—especially antibodies—are gaining in popularity in the pharmaceutical industry, both as drugs in their own right and as targeting agents for other drugs. In fact, these so-called biologics have been part of the therapeutic landscape for so long that some have already come off patent. Last year, the U.S. Food & Drug Administration approved the first generic, or biosimilar, version of a biologic drug—Zarxio, a version of the bone marrow stimulator filgrastim made by Sandoz. And just last month, FDA approved Hospira’s Inflectra, a biosimilar version of the autoimmune disease treatment infliximab.

Protein drugs, though, aren’t as simple to characterize as the small-molecule drugs that sit in most people’s medicine cabinets. Making sure that a batch of protein drugs is highly uniform or that a generic version duplicates an original biologic is a much more complex task than it is for small-molecule therapeutics.

Click here to read the full article on Chemical & Engineering News 

New drug approval and validation strategies are needed for Fast Track, Breakthrough Therapy and Accelerated Approval drugs. A new Pharmaceutical Manufacturing article, written by Tracy TreDenick, David M. Fetterolf, and Michael Boyne of BioTechLocic, explores the challenges of and new approaches for this new era in the pharmaceutical industry. Read Article

Visit BioTechLogic at Booth 308 at the BPI West conference in Oakland to enter for a chance to win a BB-8 Droid from the new Star Wars movie! While at our booth, learn about BioTechLogic’s extensive experience in Bioprocessing Validation and CMC Regulatory Submissions.

Stop by Booth 308 to discuss your process validation and CMC regulatory needs at the BioProcess International West (BPI West) Conference & Exposition. BPI West is the west coast’s largest bioprocessing event bringing you new ideas, demystifying technology, and fostering partnerships in highly engaging formats to move drug candidates closer to approval. BPI West will be held March 14-17, 2016 at the Marriott City Center in Oakland, CA.

Visit BioTechLogic at Booth 609 at the BPI conference in Boston to enter for a chance to win a BB-8 Droid from the new Star Wars movie! While at our booth, learn about BioTechLogic’s extensive experience in Bioprocessing Validation and CMC Regulatory Submissions.

BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, has announced the addition of Michael Boyne, PhD to its growing team of technical experts and consultants. Michael joins BioTechLogic from the US Food and Drug Administration where he was a Research Chemist in the Division of Pharmaceutical Analysis. As a Senior Consultant, Michael will support clients by providing expert advice on the establishment of analytical similarity for drug products using the 351 (k) pathway including protocols and requirements for statistical analysis, support the development, qualification, or validation of analytical methods used to characterize, identify, and establish the quality of intermediates, drug substances, or drug products, and draft, review, author and perform expert reviews of Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions.

While with the agency, Michael served as an expert in bioanalytical chemistry and the development and validation/qualification of bioassays, chromatography, mass spectrometry, and spectroscopy methods used for structure elucidation of complex drug products (naturally derived and biologics), for the identification and characterization of impurities and degradation products, and for evaluating the quality of US marketplace drugs. He has authored over 30 peer-reviewed publications and is an internationally recognized speaker on the application of modern analytical technologies to the evaluation of biotechnology products. Prior to joining the FDA, Michael was a postdoctoral scholar at Washington University Medical School in Saint Louis in Oncology. Michael has a BA in Chemistry from Northwestern University, Evanston, IL and a PhD in Chemistry from the University of Illinois Urbana-Champaign.

Stop by Booth 522 to meet our Oligonucleotide Manufacturing and Validation experts at TIDES 2015. IBC Lifesciences TIDES is the #1 meeting for Oligos and Peptides. TIDES will be held May 3-6, 2015 at Town and Country Resort in San Diego, CA.