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CMC Expertise Accelerating Biologics Development for 20 Years and Counting

CMC Expertise Accelerating Biologics Development Timelines for 20 Years and Counting

Tracy TreDenick-Fricke
Founding Partner, Head of Regulatory and Quality

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs for an array of biologic modalities, including gene and cell therapies, recombinant proteins, oligonucleotides, peptides, antibody-based therapeutics, recombinant proteins, vaccines, and more.

These 20 years have been exciting for the industry, as 20 years ago, large-molecule biologics had just started coming into their own. Today, they account for 46% of pharmaceutical industry revenue in the U.S., and BioTechLogic has played a meaningful role in helping to manifest the commercial prosperity of numerous biotherapeutics. We have provided CMC resources that augmented our clients’ teams through hands-on and expert consultancy to speed their journeys to the market.

Often, we helped our clients overcome significant obstacles that had or would have significantly delayed filings and commercial approval. For the last ten years, BioTechLogic has focused primarily on the gene and cell therapy sector, and we see this segment of the market maturing just as large-molecule biologics did. We have also completed many successful projects in biosimilars, synthesized macromolecules (i.e., oligonucleotides and peptides), vaccines, and combination drug product areas, and we see tremendous opportunity in these areas as well. As BioTechLogic continues celebrating its 20th anniversary, we decided to reflect on our accomplishments.

20 Years of CMC Excellence

1,400+ projects, 257 clients

Modalities Served

  • 73 gene therapy products
    • 3 approved
  • 26 cell therapy products
  • 76 biologically derived innovator products
    • 26 recombinant proteins
    • 18 vaccines
    • 23 antibodies
    • 9 blood-based products
  • 34 biosimilar products
  • 23 synthesized macromolecules
    • 15 oligonucleotides
    • 8 peptides
  • 35 combination products
    • 18 pre-filled syringes
    • 6 drug device delivery systems
    • 1 needle-free injector
    • 1 drug with excipient in a PFS
    • 1 novel therapeutic API for use in a fibrin sealant
  • 2 Type III medical devices
  • A variety of complex drug products with unique formulations
  • Led and provided the overall strategy for 57 Process Validation Programs, including:
    • 20 approved by the FDA and/or EMA
    • 2 submitted and in review by FDA and/or EMA
    • 9 ongoing global process validation programs
    • 6 – gene therapies, 2 – cell therapies, 7 – biosimilars, 8 – vaccines, 5 – antibodies, 11 – recombinant proteins, 1 – peptide, 1 – oligonucleotide, 2 – blood-based, 8 – drug-device combination products, 4 – other
  • Primary CMC author for 102 Submissions:
    • 48 INDs (2-antibodies, 3 – oligonucleotides, 3 – peptides, 1 – recombinant proteins, 7 – cell therapies, 1 modified particle, 23 – gene therapies, 4-biosimilars, 3 – drug-device combination products, 2-other)
    • 6 IMPDs (2 – gene therapies, 2 – vaccines, 1 – cell therapy, 1 – biosimilar)
    • 26 BLAs (4 – vaccines, 3-antibodies, 3- recombinant proteins, 3 – gene therapies, 1 – peptide, 4 – biosimilars, 6 – drug-device combination products, 1 – oligonucleotide, 1 – blood-based,
    • 3 BLAs / 315(K) (3 – biosimilars)
    • 2 NDAs (1 – peptide, 1 – oligonucleotide)
    • 7 MAAs (1 – vaccine, 1 – recombinant protein, 1- gene therapy, 1-biosimilar, 2 – oligonucleotides, 1 – fusion/protein combo)
    • 1 PMA (1 – drug-device combination product)
    • 9 CTAs, Health Canada (9 –gene therapies)
  • Major contributors to 31 approved submissions that have resulted in commercial products, including:
    • 17 FDA-approved biological products (BLAs and NDAs)
    • 6 EMA-approved biologic medicinal products (MAAs)
    • 2 EMA-approved biologic biosimilar (MAAs)
    • 1 FDA-approved drug/device combination product (NDA)
    • 4 FDA-approved small molecule products (NDAs)
    • 1 FDA-approved device (PMA)

It brings me a lot of joy to appreciate what we’ve accomplished throughout the last twenty years, and we’re looking forward to continuing to play our role in the industry’s success in the years to come. Thanks so much to all of you who have been a part of our journey, and we’re always looking forward to our next exciting challenge. Let us know if we can help.

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